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Welch, E. "Denis Roche: l'un ecrit, l'autre photographie." French Studies 62, no. 3 (July 1, 2008): 364–65. http://dx.doi.org/10.1093/fs/knn062.
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Magno, Luigi. "Denis Roche ou de l'écriture « comme activité torsatoire »." L'Esprit Créateur 58, no. 3 (2018): 28–37. http://dx.doi.org/10.1353/esp.2018.0030.
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Scotto, Fabio. "Denis Roche, Saggi di letteratura arrestata/Essais de littérature arrêtée." Studi Francesi, no. 169 (LVII | I) (April 1, 2013): 212–13. http://dx.doi.org/10.4000/studifrancesi.3539.
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Arena, Sara. "Denis Roche: l’un écrit, l’autre photographie, sous la direction de Luigi Magno." Studi Francesi, no. 154 (LII | I) (June 1, 2008): 224. http://dx.doi.org/10.4000/studifrancesi.9340.
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Kunz Westerhoff, Dominique. "La photographie au révélateur littéraire : de Denis Roche à Anne-Marie Garat." Études de lettres, no. 3-4 (December 15, 2013): 183–204. http://dx.doi.org/10.4000/edl.582.
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Martens, David. "Une supercherie collaborative: Claude Bonnefoy et Denis Roche dans l'ombre de Marc Ronceraille." Nottingham French Studies 58, no. 3 (December 2019): 348–65. http://dx.doi.org/10.3366/nfs.2019.0262.
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Published in 1978, Marc Roncaille by Claude Bonnefoy is a hapax in the « Écrivains de toujours » collection. It introduces an author invented from scratch by Bonnefoy, with the active complicity of the collection's director, Denis Roche, himself the author of a substantial part of the photographs that illustrate the book. This small volume appears as a carnivalesque gesture at the moment of crossing a symbolic threshold, that of the hundredth volume of the series. Suffice it to say that if this monograph relating to an imaginary writer did not really fool the public, it presents the singular characteristic of being the fruit of the work of two creators, each moving to a different field of production and therefore a different status: from a literary critic to that of writer (Bonnefoy), with the other (Roche) extending his range of activities from that of publisher to that of photographer.
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Baquey, Stéphane. "La poésie de Denis Roche. Proposition d’un protocole de lecture : une pragmatique érotique." Aletria: Revista de Estudos de Literatura 27, no. 3 (December 29, 2017): 147–71. http://dx.doi.org/10.17851/2317-2096.27.3.147-171.
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La poésie de Denis Roche est à la fois une poésie qui appelle pour elle-même la relecture, par la force de son lyrisme, et une poésie qui, du structuralisme aux renouveaux actuels de l’esthétique, soulève des questions fondamentales pour la théorie et la critique. Compte tenu de lectures antérieures (C. Prigent, J.-M. Gleize, D. Kunz), un protocole de lecture, défini comme une pragmatique érotique, est ici proposé et illustré. Il est basé sur une dimension pragmatique du poème dont la pertinence ne repose pas sur la recherche d’une entente, mais se déroule sur la scène où se dit le désir, telle que l’a analysée Jacques Lacan. Il s’agit ainsi de suggérer que la scène de l’écriture ne peut être dissociée de la scène de la lecture, autrement dit l’esthétique d’une poétique, qui est toujours une poétique singulière.
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Bricco, Elisa. "Thibaud Baldacci, L’alias e lo sciame II. Poesia & fotografia nell’opera di Denis Roche." Studi Francesi, no. 150 (L | III) (December 31, 2006): 639. http://dx.doi.org/10.4000/studifrancesi.28078.
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Welch, Edward. "Photobiographies: pour une écriture de notation de la vie (Roland Barthes, Denis Roche, Annie Ernaux)." French Studies 70, no. 1 (November 3, 2015): 127–28. http://dx.doi.org/10.1093/fs/knv296.
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Lauper, K., D. Mongin, S. A. Bergstra, D. Choquette, C. Codreanu, D. De Cock, L. Dreyer, et al. "OP0231 COMPARATIVE EFFECTIVENESS OF JAK-INHIBITORS, TNF-INHIBITORS, ABATACEPT AND IL-6 INHIBITORS IN AN INTERNATIONAL COLLABORATION OF REGISTERS OF RHEUMATOID ARTHRITIS PATIENTS (THE “JAK-POT” STUDY)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 146–47. http://dx.doi.org/10.1136/annrheumdis-2020-eular.346.
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Background:In many countries, JAK-inhibitors (JAKi) have only recently been approved as treatment for patients with rheumatoid arthritis (RA).Objectives:To evaluate the effectiveness of JAKi compared to bDMARDs in RA patients in the real-world population in an international collaboration of registers (the “JAK-pot” collaboration).Methods:Patients initiating either JAKi, TNFi, IL-6i or abatacept (ABA) during a time period when JAKi were available in each country (19 registers, Table) were included. We compared the effectiveness of JAKi and bDMARDs in terms of retention using crude and adjusted survival analysis. Missing covariates were imputed using multiple imputation.Results:Among 25521 included patients, 6063 initiated a JAKi, 13879 a TNFi, 2348 ABA, and 3231 an IL-6i. Patients were on average 55 years old, with a mean disease duration 10 years, mostly seropositive (67%), female (77%) and with moderate disease activity at treatment initiation. The main reason of stopping treatment was ineffectiveness (49%), followed by adverse events (21%). Patients on JAKi were treated more often as monotherapy, had higher CRP and disease activity at baseline and had experienced more previous ts/bDMARDs. Crude median retention was 1.4 (95% CI 1.2-1.5) years for JAKi, 1.6 (1.6-1.7) for TNFi, 1.5 (1.3-1.7) for IL6i and 1.1 (1.0-1.3) for ABA. After adjustment, the hazard ratio (HR) for discontinuation tended to be lower for JAKi (HR 0.86 (0.65-1.13)) compared to TNFi, but comparable for ABA (1.02 (0.94-1.10)) and IL6i (0.99 (0.88-1.10)) (Figure 1). HRs differed notably between countries (Figure 2).Table 1.RegistersCountry, registerNJAKi, n (%)Austria, BIOREG*Belgium, TARDIS62882113 (33.6)Canada, RHUMADATA528114 (21.6)Czech Republic, ATTRA374253 (67.6)Denmark, DANBIO4721506 (10.7)Finland, ROB-FIN807234 (29.0)Germany, RABBIT*Italy, GISEA757250 (33.0)Israel, I-RECORD40094 (23.5)Netherlands, METEOR16424 (0.2)Norway, NOR-DMARD50799 (19.5)Portugal, REUMA.PT79744 (5.5)Romania, RRBR593328 (55.3)Russia, ARBITER526483 (91.8)Slovenia, BIORX.SI583146 (25.0)Spain, BIOBADASER781139 (17.8)Switzerland, SCQM2956796 (26.9)Turkey, TURKBIO2150397 (18.5)UK, BSRBR111163 (5.7)*Registers planning to participate in future studies but not included yetConclusion:The adjusted overall drug retention of JAKi tended to be higher than for TNFi, with large variation between countries. Other measures of effectiveness, such as the evaluation of CDAI remission and low disease activity are planned to shape a more comprehensive picture of JAKi effectiveness in the real world.Disclosure of Interests:Kim Lauper: None declared, Denis Mongin: None declared, Sytske Anne Bergstra: None declared, Denis Choquette Grant/research support from: Rhumadata is supported by grants from Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Consultant of: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Speakers bureau: Pfizer, Amgen, Abbvie, Gylead, BMS, Novartis, Sandoz, eli Lilly,, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Diederik De Cock: None declared, Lene Dreyer: None declared, Ori Elkayam Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Novartis, Jansen, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Nevsun Inanc: None declared, Eirik kristianslund: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Burkhard Leeb Grant/research support from: chairman of BioReg, Consultant of: AbbVie, Pfizer, Roche, Lilly, Grünenthal, Gebro,, Paid instructor for: Lilly, Biogen, Speakers bureau: Biogen, Lilly, Pfizer, Grünenthal, Astropharma,, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Dan Nordström Consultant of: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Speakers bureau: Abbvie, Celgene, Lilly, Novartis, Pfizer, Roche and UCB., Karel Pavelka Consultant of: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Speakers bureau: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Delphine Courvoisier: None declared, Axel Finckh Grant/research support from: Pfizer: Unrestricted research grant, Eli-Lilly: Unrestricted research grant, Consultant of: Sanofi, AB2BIO, Abbvie, Pfizer, MSD, Speakers bureau: Sanofi, Pfizer, Roche, Thermo Fisher Scientific
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SERRY, HERVÉ. "The Work of Editing, its Context and Transformations: Denis Roche’s Fiction & Cie Collection (1974-2004)." Australian Journal of French Studies 58, no. 2 (July 1, 2021): 123–36. http://dx.doi.org/10.3828/ajfs.2021.11.
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Drawing on source material from archives and press articles, this article presents the conditions in which the Fiction & Cie collection, published by Éditions du Seuil, was founded by Denis Roche in 1974 and how it subsequently evolved. Imagined by an avant-garde writer, this collection offered a new editorial model that ultimately brought about a reconfiguration of the power dynamics within Le Seuil. It illustrates how, at the end of the 1970s, as Marxist or structuralist theoretical-political debates subsided, space opened up for other approaches to editing and aesthetics. Through the prism of Roche’s editorial practice, the relationship between different forms of aesthetic discourse and editorial logic over a period of three decades is examined. Translated by Daniel Henkel
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Libasci, Fabio. "Fabien Arribert-Narce, Photobiographies. Pour une écriture de la notation de vie (Roland Barthes, Denis Roche, Annie Ernaux)." Studi Francesi, no. 179 (LX | II) (September 1, 2016): 366. http://dx.doi.org/10.4000/studifrancesi.4476.
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Kostakoglu, Lale, Maurizio Martelli, Laurie H. Sehn, David Belada, Angelo-Michele Carella, Neil Chua, Eva Gonzalez-Barca, et al. "Baseline PET-Derived Metabolic Tumor Volume Metrics Predict Progression-Free and Overall Survival in DLBCL after First-Line Treatment: Results from the Phase 3 GOYA Study." Blood 130, Suppl_1 (December 7, 2017): 824. http://dx.doi.org/10.1182/blood.v130.suppl_1.824.824.
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Abstract Introduction: Quantitative 18fluorodeoxyglucose positron emission tomography (PET)/computed tomography assessment using total metabolic tumor volume (TMTV) and tumor lesion glycolysis (TLG) measurements has been found promising as an objective method to predict survival in diffuse large B-cell lymphoma (DLBCL) patients (pts). However, the methodology for PET-derived metrics is still evolving, and their predictive value is yet to be proven in large-scale, prospective, multicenter studies. We investigated the prognostic value of baseline maximum standardized uptake value (SUVmax), TMTV and TLG for progression-free survival (PFS) in a large pt cohort treated with obinutuzumab (GA101; G) or rituximab (R) combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in the Phase 3 GOYA study (NCT01287741; Vitolo et al. J Clin Oncol 2017). Methods: Pts aged ≥18 years, with previously untreated, CD20-positive DLBCL and an International Prognostic Index (IPI) score ≥2 and low-risk pts with IPI scores of 1 (not due to age alone) or 0 (with bulky disease) were randomized 1:1 to receive 8 x 21-day cycles of G (1000mg intravenous [IV] on Days [D] 1, 8, and 15 of Cycle [C] 1 and D1, C2-8) or R (375mg/m2 IV on D1, C1-8) plus 6 or 8 cycles of CHOP. All pts had a baseline and end of treatment (EOT) PET. PET images were segmented using an automated workflow program in MIM software, applying thresholds of 1.5 x liver background and a minimum volume of 1mL to the whole body PET images. The data were analyzed for the overall population and according to germinal center B-cell-like (GCB), unclassified, and activated B-cell-like (ABC) subtypes of DLBCL. TMTV, TLG, and SUVmax were split into 4 categories/levels according to the following quartiles: Q1, <25%; Q2, 25-50%; Q3, 50-75%; and Q4, 75-100%, which were obtained based on their distribution in the available population. The reported hazard ratios (HRs) refer to stratified log-rank tests comparing Q2, Q3, and Q4 to Q1, adjusted for stratification factors of the study: IPI score (low [0-2], intermediate [3], and high [4-5]) and number of planned CHOP cycles (6 or 8). Results: Of 1418 enrolled pts, 1346 had a baseline PET scan and 1334 had detectable lesions. There was no statistical difference in PFS between the treatment arms (G vs R), thus the entire cohort was analyzed as a whole. Results of the predictive value of baseline TMTV for PFS are presented in quartiles in Figure 1, and results of the predictive value of TLG for PFS are presented in quartiles in Figure 2, for the overall PET intent-to-treat population. After a median follow-up of 29 months TMTV and TLG were highly predictive of PFS when comparing Q4 vs Q1: HR=2.21, 95% CI 1.48-3.29, p<0.0001, and HR=1.91, 95% CI 1.28-2.85, p=0.0005, respectively. TMTV was also predictive of overall survival (OS): HR=2.63, 95% CI 1.55-4.46; p<0.0001. However, SUVmax-based prediction of PFS was not statistically significant (HR=0.84, 95% CI 0.57-1.23, p=0.3782). Three-year PFS for pts in TMTV Q1, 2, 3 and 4 was 86% (95% CI 81-89%), 84% (95% CI 78-88%), 78% (95% CI 72-83%) and 66% (95% CI 59-71%), respectively. TMTV also showed a trend for a better prediction of PFS (Figure 3) and OS in pts with the unclassified and ABC DLBCL subtypes when compared with those with the GCB subtype. Conclusions: This large prospective study confirms baseline TMTV and TLG as predictors of PFS and OS in DLBCL after first-line immunochemotherapy, while SUVmax may not be a predictor. Furthermore, TMTV and TLG appear to be better predictors of survival for pts with the unclassified and ABC subtypes of DLBCL than for those pts with the GCB subtype. Further analyses are underway comparing these results with the predictive value of percentage change from baseline to EOT PET, Deauville score-based analysis of EOT PET, and the various molecular DLBCL subtypes. Figure 1 Figure 1. Disclosures Kostakoglu: Roche: Consultancy, Other: GOYA is sponsored by F. Hoffmann-La Roche Ltd. Third-party editorial support, under the direction of Lale Kostakoglu and Denis Sahin, was provided by Helen Cathro of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd. Sehn: Celgene: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Roche/Genentech: Consultancy, Honoraria. Chua: Lundbeck: Honoraria; Roche: Honoraria; Seattle Genetics: Honoraria; Gilead Sciences: Honoraria; Merck: Honoraria. Gonzalez-Barca: Gilead: Consultancy; Sandot: Consultancy; Janssen: Speakers Bureau; Roche: Speakers Bureau. Pinto: Millenium Takeda: Research Funding; Gilead: Honoraria; Roche: Honoraria; Bristol Myers Squibb: Honoraria; Merck Sharp Dome: Honoraria; Celgene: Honoraria; Helssin: Honoraria; Mundipharma EDO: Speakers Bureau. Fingerle-Rowson: F. Hoffmann-La Roche Ltd: Employment, Equity Ownership. Knapp: Roche: Employment. Mattiello: Roche: Employment. Nielsen: F. Hoffmann-La Roche Ltd: Employment, Equity Ownership. Sellam: Roche: Employment. Sahin: Roche: Employment, Equity Ownership. Vitolo: Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria; Mundipharma: Honoraria; Takeda: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Trněný: Janssen: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; BMS: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding.
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Barnett, R. L. Etienne. "Jeux transgressifs." Revue Romane / Langue et littérature. International Journal of Romance Languages and Literatures 46, no. 1 (June 27, 2011): 127–35. http://dx.doi.org/10.1075/rro.46.1.06bar.
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In the textualized universe of Denis Roche, the poetic impulse is inextricably linked to the unstable framework in which such matter is cast. Utterances of language translate the power of transgression.The text is birthed as an object of inquiry, ultimately to be dismantled : the poem is both “inadmissible” and “inexistant.” As a self-fixed interrogator focused upon the residual matter that it is and which it only can be, it is no longer subservient to the references it struggles to invoke, much less to signify. Writing, then, is an unending auto-reflexive process of annihilation and reification, and subsists, as such, to the sole extent that it disassociates from all conventional voices of articulation. More obtusely, to poeticize is to re-transcribe — otherly and with abruptness — the withered sputtering(s) of the artistic imperative. Poetry, like photography, aims and frames, slices the world into sequences and images — partial, scattered, at once undone so as to be resuscitated, briefly, again. The extant is eschewed. At stake and at center-stage : a propelled form of motivity, speed, accelerations and dead-stops, an aleatory array of unremitting shifts, “instantanées” — obstinately un-emblematic. Raging or controlled, the poem or the photo can only be a non-representational sliver, the transitory residue of an infinite combinatorics of possibles. Hence, arbitrary breaches, clamoring interruptions, ludic contortions of incompleteness. A curious dynamic.
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Maksymowych, W. P., S. Juhl Pedersen, U. Weber, P. M. Machado, X. Baraliakos, J. Sieper, S. Wichuk, et al. "FRI0302 WHAT IS THE IMPACT OF DISCREPANCY BETWEEN CENTRAL AND LOCAL READERS IN EVALUATION OF MRI SCANS ON THE CLASSIFICATION OF AXIAL SPONDYLOARTHRITIS? DATA FROM THE ASAS CLASSIFICATION COHORT STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 740.2–741. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6350.
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Background:Active MRI lesions typical of axial spondyloarthritis (axSpA) were reported in 61.6% and 2.2% of axSpA and not-axSpA patients, respectively, from the ASAS classification cohort (ASAS-CC)1. Discrepancy between local and central reader evaluation of MRI scans could result in differences in numbers of patients fulfilling the imaging arm of the ASAS classification criteria. But final classification may not be impacted if discrepant patients still fulfill the clinical arm.Objectives:We aimed to assess the impact of reader discrepancy in detection of active MRI lesions on the number of patients classified as having axSpA in patients recruited to the ASAS-CC.Methods:MRI images of the sacroiliac joints (SIJs) were available from 252 cases in the ASAS-CC, and these also had clinical and radiographic data. Seven central readers from the ASAS-MRI group recorded MRI lesions in an eCRF that included active lesions typical of axSpA in the SIJ (MRI-active) that was worded exactly the same as in the original ASAS-CC eCRF permitting comparisons between central and local site readers. Active lesions were deemed to be present according to majority agreement (≥4/7) of central readers and also any 2 central readers. We calculated the number of patients that were classified differently after central evaluation for overall fulfilment of the ASAS criteria and for the imaging arm.Results:Discordance between central and local readers for detection of MRI-active was recorded in 45(17.8%) and 47(18.2%) of cases according to 2-reader and majority (≥4/7) central reader data, respectively (kappa (95%CI) of 0.64 (0.54-0.73) and 0.62 (0.53-0.72). With central reading as external standard the false-positive rate for active lesions was 26.9%% and 32.2% (‘local overcall’) for 2-reader and majority reader data, respectively. There were 159(63.1%) patients who fulfilled the ASAS axSpA criteria based on local-reading, and 148(58.7%) and 143(56.7%) patients based on 2-reader and majority central-reading, respectively (Table). When fulfillment of the imaging arm was the primary consideration (irrespective of the clinical arm), 126 (50%) patients fulfilled the criteria based on local-reading, and 111 (44%) and 102 (40.5%) patients based on 2-reader and majority central-reading, respectively.Conclusion:Despite substantial overcall for positive MRI SIJ inflammation by local readers, the number of patients classified as having axSpA did not change substantially. This is due to the alternate mechanism for classification through the clinical arm.References:[1]Rudwaleit et al. Ann Rheum Dis 2009;68: 777-83Impact of Central Vs. Local Reader SIJ MRI Inflammation Assessment on SpA Classification in cases with all clinical, radiographic, and central and local MRI inflammation data available (n=252)MRI assessment usedSpA Classification = Yes N(%)SpA Classification = No N(%)Imaging Arm SpA Classification = Yes N(%)Imaging Arm SpA Classification = No N(%)Local Reader MRI positive159 (63.1%)93 (36.9%)126 (50%)126 (50%)>2 Central Reader MRI positive148 (58.7%)104 (41.3%)111 (44.0%)141 (56.0%)Majority Central Reader (≥4/7) MRI positive143 (56.7%)109 (43.2%)102 (40.5%)150 (59.5%)Disclosure of Interests:Walter P. Maksymowych Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, and UCB, Susanne Juhl Pedersen Grant/research support from: Novartis, Ulrich Weber: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Stephanie Wichuk: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Joel Paschke: None declared, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Robert G Lambert: None declared
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Maksymowych, W. P., X. Baraliakos, U. Weber, P. M. Machado, S. Juhl Pedersen, J. Sieper, S. Wichuk, et al. "OP0079 PRELIMINARY DEFINITION OF A POSITIVE MRI FOR STRUCTURAL LESIONS IN THE SACROILIAC JOINTS IN AXIAL SPONDYLOARTHRITIS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 53–54. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6264.
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Background:There is lack of international consensus as to what defines a structural lesion on MRI of the sacroiliac joints (SIJ) typical of axial spondyloarthritis (axSpA). The ASAS MRI group has generated updated consensus lesion definitions that describe each of the MRI lesions in the SIJ1. These definitions have been evaluated by 7 readers from the ASAS-MRI group on MRI images from the ASAS Classification Cohort.Objectives:We aimed to identify quantitative cut-offs based on numbers of slices and SIJ quadrants that define a positive MRI for structural lesions typical of axSpA, the gold standard being majority central reader decision as to the presence of a structural lesion typical of axSpA with high confidence.Methods:MRI structural lesions meeting ASAS definitions were recorded in an eCRF that comprises global assessment (structural lesion typical of axSpA present/absent and degree of confidence (-4 (absent) to +4 (present)), and detailed scoring of lesions per SIJ quadrant. Detailed scoring was based only on assessment of DICOM images (n =148). We calculated sensitivity and specificity for numbers of SIJ quadrants and consecutive slices with erosion, sclerosis, and fat lesions where a majority of readers (≥4/7) agreed as to the presence of a structural lesion typical of axSpA with high confidence (≥ +3). We tested candidate lesion definitions for predictive diagnostic utility in cases assessed after 4.4 years of follow up by the local rheumatologist.Results:Structural lesions typical of axSpA were observed by majority read in 33 (32.4%) of 102 cases diagnosed with axSpA, and 3 (6.8%) of 44 cases without axSpA and 29 cases were assigned a high degree of confidence (≥ +3) by a majority of readers. Cut-offs achieving specificity of 95% were erosion in ≥2 consecutive slices (sensitivity 83%), erosion ≥3 SIJ quadrants (sensitivity 90%), and fat lesion (≥1cm horizontal depth) in ≥1 SIJ quadrant (sensitivity 59%) (Table). These had very high positive predictive values (>95%) for diagnosis of axSpA in cases diagnosed by the rheumatologist after 4.4 years follow up.Conclusion:ASAS-defined erosion in ≥2 consecutive slices or in ≥3 SIJ quadrants and ASAS-defined fat lesion with depth >1cm in ≥1 SIJ quadrant are high priority candidates for defining an MRI structural lesion typical of axSpA. This will require similar assessment in additional axSpA cohorts.References:[1]Maksymowych et al. Ann Rheum Dis 2019; 78:1550-8.Table 1.Majority readers agree structural lesion indicative of axSpA is present with confidence ≥3/4 is the gold-standard external referenceSensitivitySpecificityErosion Score ≥1 SIJ qdr93.1 (77.2-99.2)80.6 (72.4-87.3)Erosion Score ≥2 SIJ qdr93.1 (77.2-99.2)90.8 (84.1-95.3)Erosion Score ≥3 SIJ qdr89.7 (72.6-97.8)95.8 (90.5-98.6)Erosion in 2 consecutive slices82.8 (64.2-94.2)95.0 (89.3-98.1)Fat lesion ≥1 SIJ qdr82.8 (64.2-94.2)81.5 (73.4-88.0)Fat lesion ≥2 SIJ qdr69.0 (49.2-84.7)86.6 (79.1-92.1)Fat lesion ≥3 SIJ qdr62.1 (42.3-79.3)91.6 (85.1-95.9)Fat lesion in 2 consecutive slices55.2 (35.7-73.6)93.3 (87.2-97.1)Fat lesion (>1cm depth) ≥158.6 (38.9-76.5)95.0 (89.3-98.1)Fat lesion (>1cm depth) ≥255.2 (35.7-73.6)95.8 (90.5-98.6)Fat lesion (>1cm depth) ≥351.7 (32.5-70.6)97.5 (92.8-99.5)Fat lesion (>1cm depth) in 2 consecutive slices48.3 (29.4-67.5)97.5 (92.8-99.5)Table. SIJ qdr: sacroiliac joint quadrantDisclosure of Interests:Walter P. Maksymowych Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, and UCB, Xenofon Baraliakos: None declared, Ulrich Weber: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Susanne Juhl Pedersen Grant/research support from: Novartis, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Stephanie Wichuk: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Joel Paschke: None declared, Robert G Lambert: None declared, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB
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Torgutalp, M., M. Protopopov, F. Proft, J. Sieper, V. Rios Rodriguez, H. Haibel, M. Rudwaleit, and D. Poddubnyy. "FRI0303 PERIPHERAL SYMPTOMS ARE ASSOCIATED WITH LESS SPINAL RADIOGRAPHIC PROGRESSION IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 741. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3397.
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Background:Peripheral symptoms (PS), such as arthritis, enthesitis, and dactylitis, are common in axial spondyloarthritis (axSpA); data showing the association of PS and spinal radiographic progression in axSpA are controversial.Objectives:To analyze the association of PS and spinal radiographic progression in patients with axSpA.Methods:A total of 210 patients with axSpA (115 with radiographic and 95 with non-radiographic axSpA) were selected for analysis. Spinal radiographs were scored by two readers in a random order according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Pelvic radiographs were scored according to the grading system of the modified New York criteria; a sacroiliitis sum score was calculated as a sum of the grades for both sacroiliac joints. Mann-Whitney and Fisher exact tests were performed for group comparisons. A multivariable regression analysis was performed to analyze the influence of PS on radiographic progression.Results:Of the 101 (48.1%) patients with PS, 78 had peripheral arthritis, 48 - enthesitis, 12 - dactylitis. 32 patients had ≤1 PS. Patients with PS were older, less frequently HLA-B27 positive, compared with patients with no PS (73 (73.0%) vs. 93 (85.3%), p=0.028), had higher disease activity (time-averaged ASDAS over 2 years 2.6 ± 0.9 vs. 2.3 ± 0.9; p=0.032), worse physical function (BASFI 3.5 ± 2.3 vs. 2.3 ± 2.2, p<0.001), higher exposure to disease modifying anti-rheumatic drugs (39 (38.6%) vs. 22 (20.2%), p=0.003) and lower baseline radiographic sacroiliitis sum score (3.8 ± 1.9 vs. 4.4 ± 2.1, p=0.026); other baseline characteristics were similar. Patients with PS had lower absolute progression in mSASSS after 2 years of follow-up than those without (0.28 ± 1.39 vs 1.15 ± 2.9, p=0.045); 7.9% of patients with PS had a progression of mSASSS by ≥2 points compared to 20.2% in patients without PS (p=0.011). Radiographic progression of sacroiliitis was similar in both groups. In a multivariable regression analysis, presence of PS was associated with a lower mSASSS progression and lower odds for the mSASSS progression by ≥2 points after 2 years of follow-up: β=-0.98 (95% -1.68 to -0.28) OR=0.33 (95% CI 0.12 to 0.91), respectively – Table 1.Table 1.Association of peripheral symptoms with radiographic progression in axial spondyloarthritis after 2 years of follow-up.Multivariable linear regression analysisOutcomeβ (95 %CI)mSASSS change score−0.98 (-1.68 to -0.28)*Change of the sacroiliitis sum score−0.06 (-0.32 to 0.20)**Multivariable logistic regression analysisOutcomeOdds ratio (95 %CI)Progression of mSASSS by ≥2 points0.33 (0.12 to 0.91)*Progression of sacroiliitis by at least 1 grade in opinion of both readers0.84 (0.33 to 2.09)**mSASSS - modified Stoke Ankylosing Spondylitis Spine Score.*Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, baseline syndesmophytes, and time-averaged ASDAS.**Adjusted for the smoking status, HLA-B27 status, NSAIDs intake, sacroiliitis sum score at baseline, and time-averaged ASDAS.Conclusion:Presence of PS is associated with distinct characteristics of SpA including slower radiographic spinal progression which might be explained partly by the numerically lower mSASSS score at baseline.Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research (BMBF). As funding by BMBF was reduced in 2005 and stopped in 2007, financial support has been obtained from Abbott / Abbvie, Amgen, Centocor, Schering-Plough, and Wyeth. Since 2010 GESPIC is supported by Abbvie.Dr. Murat Torgutalp was supported by the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Protopopov, M., M. Torgutalp, J. Sieper, H. Haibel, F. Proft, V. Rios Rodriguez, M. Rudwaleit, and D. Poddubnyy. "AB0716 SEX DIFFERENCES IN CLINICAL PHENOTYPE AND RADIOGRAPHIC DISEASE PROGRESSION IN AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE GERMAN SPONDYLOARTHRITIS INCEPTION COHORT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1653.2–1654. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4862.
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Background:It is presumed that the phenotype of the axial spondyloarthritis (axSpA) may differ in females and males; the published data are controversial.Objectives:To explore the sex differences in disease features and radiographic progression in axSpA.Methods:A total of 210 patients with axSpA (115 with radiographic and 95 with non-radiographic axSpA) were selected for analysis. Spinal radiographs were scored by two readers in a random order according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Pelvic radiographs were scored according to the grading system of the modified New York criteria; a sacroiliitis sum score was calculated as a sum of the grades for both sacroiliac joints. Mann-Whitney and Fisher exact tests were performed for group comparisons. A multivariable regression analysis was performed to analyze the influence of gender on radiographic progression.Results:Males (n=107; 51%) were significantly younger at disease onset (34.8 ± 10.3 vs. 31.5 ± 11.2 years, p=0.008) and at diagnosis (37.5 ± 10.2 vs. 34.1 ± 11.2 years, p=0.006); symptom duration at baseline was similar (4.1 ± 2.6 vs. 4.3 ± 2.8 years, p=0.66). Females were less often HLA-B27 positive (74 (72.5%) vs. 92 (86.0%), p=0.02), had higher baseline disease activity (BASDAI 4.3±2.2 vs 3.7±2.0; p=0.05), but lower baseline C-reactive protein level (7.1 ± 10.9 vs. 12.3 ±18.2 mg/l, p=0.08), and similar time-averaged ASDAS (2.5±0.8 vs 2.4±1.0; p=0.385). Males more frequently had definite radiographic sacroiliitis (70.1% vs. 38.8%; p<0.001), higher sacroiliitis sum score (4.9 ±1.9 vs 3.2±1.8, p<0.001), and higher mean mSASSS (6.1 ± 10.7 vs 2.4 ± 4.0; p=0.100) at baseline. Other variables were comparable between the groups. There was a trend for a higher radiographic progression in males in all explored outcomes, statistically significant only for the formation/progression of syndesmophytes (23 (21.5%) vs. 10 (9.7%), p=0.023), with no differences in the radiographic progression of sacroiliitis. In a multivariate logistic regression analysis, similar odds for spinal radiographic progression, new syndesmophyte formation and radiographic progression of sacroiliitis by ≥1 grade were seen –Table 1.Conclusion:There was a trend for male patients to have more radiographic damage at the baseline and more progression after two years, as reflected by the percentage of patients with new syndesmophytes.:Table 1.Association of sex with radiographic progression in spine and sacroiliac joints after 2 years of follow-up.Parameter, n (%) or mean±SDFemale(n=103)Male(n=107)PSpinal radiographic progressionmSASSS change0.46 ± 1.631.00 ± 2.850.25Progression of mSASSS by ≥2 points10 (9.7)20 (18.7)0.08New syndesmophytes or progression of syndesmophytes10 (9.7)23 (21.5)0.02Progression of radiografic sacroiliitisChange of the sacroiliitis sum score0.14 ± 0.940.13 ± 0.730.58Progression of sacroiliitis by at least 1 grade in opinion of both readers17 (16.5)9 (8.4)0.09mSASSS – modified Stoke Ankylosing Spondylitis Spine Score;Acknowledgments:GESPIC has been financially supported by the German Federal Ministry of Education and Research (BMBF). As funding by BMBF was reduced in 2005 and stopped in 2007, financial support has been obtained from Abbott / Abbvie, Amgen, Centocor, Schering-Plough, and Wyeth. Since 2010 GESPIC is supported by Abbvie.Dr. Murat Torgutalp was supported by the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Mikhail Protopopov Consultant of: Novartis, Murat Torgutalp: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Regierer, A., A. Weiß, X. Baraliakos, D. Poddubnyy, I. Schwarze, J. Braun, J. Sieper, A. Zink, and A. Strangfeld. "SAT0391 DEPRESSIVE SYMPTOMS ARE ASSOCIATED WITH HIGHER DISEASE ACTIVITY AND WORSE FUNCTIONAL STATUS IN AXSPA: A CROSS-SECTIONAL ANALYSIS FROM RABBIT-SPA." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1144.2–1145. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2767.
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Background:Axial spondyloarthritis (axSpA) is a potentially severe chronic inflammatory disease with impact on function and quality of life. About 20-30% of axSpA patients show symptoms of depression or are diagnosed with depression [1]. Depression may influence outcome, especially patient reported outcomes.Objectives:To assess differences in baseline characteristics and outcome parameters between patients with and without symptoms of depression using WHO-5 score.Methods:RABBIT-SpA is a prospective longitudinal cohort study including axSpA patients enrolled at start of a new conventional treatment (including NSAID) or bDMARD. WHO-5 score was used to identify depressive symptoms categorised into 3 groups using validated cut-offs: moderate to severe depressive symptoms <=28, mild depressive symptoms 29-50, good well-being >50. Baseline values of patients categorised as having moderate to severe depressive symptoms were compared with the rest of the patients using t-test. Spearman correlation coefficient was calculated to analyse the relationship between WHO-5 score and other outcome parameters.Results:A total of 848 axSpA patients were included in this analysis (table 1). Moderate to severe depressive symptoms were found in 221 patients (30%), 226 (31%) had mild depressive symptoms and 285 (39%) reported a good well-being. Percentages of patients with inflammatory back pain, peripheral arthritis or enthesitis as well as the number of affected joints (44 JC) and entheseal sites (using SPARCC) were higher in the group of patients with moderate to severe depressive symptoms.Table 1.ParameterWHO-5 (<=28)Moderate severeN=221WHO-5 (29-50/>50)Mild/well-beingN=511Age, mean43.844.1Female, n (%)100 (45.2)229 (44.8)Disease duration, years, mean6.86.5Inflammatory back pain, n (%)195 (88.6)416 (81.6)Enthesitis, n (%)49 (22.3)78 (15.4)Peripheral arthritis (44 JC), n (%)64 (29.1)134 (26.3)Uveitis, n (%)45 (20.4)76 (15)IBD, n (%)13 (5.9)31 (6.1)Psoriasis, n (%)35 (15.8)58 (11.4)CRP positive (≥5mg/l), n (%)115 (59)243 (55.1)HLA-B27, n (%)151 (72.6)354 (74.2)BMI≥30, n (%)66 (30)117 (23.6)Comorbidities ≥3, n (%)50 (22.6)89 (17.4)Current smoking, n (%)102 (47.2)185 (36.7)All analysed outcome parameters (e.g. ASDAS, ASAS-HI, BASDAI, BASFI, patient global, physician global, pain, sleep) were significantly worse in the group of patients with moderate to severe depressive symptoms versus the other patients (table 2). This includes physician-reported, patient-reported and composite scores.Table 2.ParameterWHO-5 (<=28)Moderate severeN=221WHO-5 (29-50/>50)Mild/well-beingN=511p-valuePhysGA (NRS 0-10)6.2 (1.6)5.4 (1.9)0.0001ASDAS6.1 (1.6)4.2 (1.8)0.0001BASDAI (NRS 0-10)3.5 (0.8)2.9 (0.9)0.0001BASFI (NRS 0-10)5.5 (2.2)3.2 (2.2)0.0001ASAS-HI (0-17)9.8 (3.1)5.8 (3.1)0.0001PatGA (NRS 0-10)7 (1.8)5.4 (2.3)0.0001PatPain (NRS 0-10)6.9 (1.9)5.2 (2.3)0.0001PatSleep (NRS 0-10)7.2 (2.4)4.6 (2.9)0.0001Results are presented as mean ± SD.WHO-5 was highly correlated with all outcome parameters regardless of gender. Figure 1 shows the correlation of BASDAI and WHO-5 stratified for gender.Figure 1.Conclusion:Almost one third (30%) of axSpA patients in this analysis reported scores indicative of depressive symptoms and depression. The strong correlation of WHO-5 scores with patient and physician reported outcomes may be relevant for the management of patients with axSpA.References:[1]Redeker I, et al. Ann Rheum Dis 2018;0:1–8. doi:10.1136Acknowledgments:RABBIT-SpA is supported by a joint, unconditional grant from AbbVie, Amgen, Janssen-Cilag, Lilly, MSD, Mylan, Novartis, Pfizer, and UCB.Disclosure of Interests:Anne Regierer Speakers bureau: Novartis, Celgene, Janssen-Cilag, Anja Weiß: None declared, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Ilka Schwarze: None declared, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Angela Zink Speakers bureau: AbbVie, Amgen, BMS, Gilead, Hexal, Janssen, Lilly, MSD, Pfizer, Roche, Sanofi Aventis, UCB, Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis
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Maksymowych, W. P., I. Eshed, P. M. Machado, S. Juhl Pedersen, U. Weber, M. De Hooge, J. Sieper, et al. "FRI0317 CONSENSUS DEFINITIONS FOR MRI LESIONS IN THE SPINE OF PATIENTS WITH AXIAL SPONDYLOARTHRITIS: FIRST ANALYSIS FROM THE ASSESSMENTS IN SPONDYLOARTHRITIS INTERNATIONAL SOCIETY CLASSIFICATION COHORT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 749.2–750. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6304.
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Background:A recent consensus from the ASAS MRI group has culminated in updated spine lesion definitions for axial spondyloarthritis (ASAS_MRI_defn)1. There has been no central reader evaluation of MRI scans from the ASAS Classification Cohort (ASAS-CC)2to determine the spectrum of MRI lesions in the spine in this cohort.Objectives:To determine the spectrum of active and structural lesions on MRI images of the spine from the ASAS-CC according to the consensus ASAS_MRI_defnupdate.Methods:ASAS_MRI_defnwere recorded by 9 central readers in an eCRF for global assessment and detailed scoring of each discovertebral unit and postero-lateral structures. Vertebral corner bone marrow edema (VCBME) and corner fat (VCFAT) lesions were recorded if present on 2 slices; facet joint, lateral, and posterior inflammatory lesions were recorded if present on a single slice. Vertebral corner erosion, bone spurs, and ankylosis were each scored on a single slice. Comparison of active and structural lesion frequencies by local rheumatologist diagnosis of axSpA was assessed descriptively according to ≥2 and majority reader (≥5/9) concordant data.Results:MRI scans of the spine were available from 69 cases with axSpA diagnosed in 44/64 (68.8%). VCBME was most frequent with ≥1 lesion in 32(46.4%) and 19 (27.5%) by ≥2 and ≥5/9 readers, respectively. VCFAT was the most frequent structural lesion with ≥1 lesion in 24 (34.8%) and 14 (20.3%) by ≥2 and ≥5/9 readers, respectively. There were significantly more VCBME lesions in axSpA patients than non-axSpA (mean(SD):1.8(2.7) vs 0.3 (0.5)) (p<0.001) while differences in VCFAT were not significant (Table). The presence of ≥2 VCBME had 90-95% specificity for axSpA. Significantly more VCBME and VCFAT were observed in the setting of radiographic sacroiliitis (modified New York criteria (mNY)).Conclusion:Spine lesions on MRI are relatively frequent in patients with undiagnosed back pain presenting to the rheumatologist. The presence of ≥2 VCBME, but not VCFAT, may have some diagnostic utility.References:[1]Maksymowych WP, et al. Arthritis Rheumatol 70 (suppl 10): 654, 2018[2]Rudwaleit et al. Ann Rheum Dis 2009;68: 777-83Vertebral Corner MRI lesionsmajority of readers (>=5)≥2 readersaxSpA=Yes (n=44)axSpA=No (n=20)p-valueaxSpA=Yes (n=44)axSpA=No (n=20)p-valueCorner Fat ≥112 (27.3%)2 (10%)0.1917 (38.6%)7 (35%)0.78Corner Fat ≥210 (22.7%)2 (10%)0.3113 (29.5%)4 (20%)0.64Corner Fat ≥38 (18.2%)1 (5%)0.2510 (22.7%)3 (15%)0.74Corner Fat ≥47 (15.9%)1 (5%)0.429 (20.5%)2 (10%)0.48Corner BME ≥117 (38.6%)1 (5%)0.00625 (54.5%)6 (30%)0.047Corner BME ≥215 (34.1%)1 (5%)0.01319 (43.2%)2 (10%)0.009Corner BME ≥311 (25%)0 (0%)0.01316 (36.4%)1 (5%)0.008Corner BME ≥48 (18.2%)0 (0%)0.09412 (27.3%)1 (5%)0.048mNY=Yes (n=10)mNY=No (n=49)p-valuemNY=Yes (n=10)mNY=No (n=49)p-valueCorner Fat ≥15 (50%)9 (18.4%)0.0475 (50%)17 (34.7%)0.48Corner Fat ≥25 (50%)7 (14.3%)0.0225 (50%)11 (22.4%)0.12Corner Fat ≥34 (40%)5 (10.2%)0.0364 (40%)9 (18.4%)0.20Corner Fat ≥44 (40%)4 (8.2%)0.0224 (40%)7 (14.3%)0.079Corner BME ≥15 (50%)11 (22.4%)0.1167 (70%)22 (44.9%)0.18Corner BME ≥25 (50%)9 (18.4%)0.0475 (50%)14 (28.6%)0.27Corner BME ≥35 (50%)6 (12.2%)0.0145 (50%)11 (22.4%)0.12Corner BME ≥45 (50%)3 (6.1%)0.0025 (50%)7 (14.3%)0.022Disclosure of Interests:Walter P. Maksymowych Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, and UCB, Iris Eshed: None declared, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Susanne Juhl Pedersen Grant/research support from: Novartis, Ulrich Weber: None declared, Manouk de Hooge: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Stephanie Wichuk: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Robert G Lambert: None declared, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen
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Maksymowych, W. P., P. M. Machado, R. G. Lambert, X. Baraliakos, M. Ǿstergaard, J. Sieper, S. Wichuk, et al. "SAT0384 REPLACEMENT OF RADIOGRAPHIC SACROILITIS BY MRI STRUCTURAL LESIONS: WHAT IS THE IMPACT ON CLASSIFICATION OF AXIAL SPONDYLOARTHRITIS IN THE ASAS CLASSIFICATION COHORT?" Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1140.2–1141. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6369.
Full textAbstract:
Background:Classification of axial spondyloarthritis (axSpA) is based on either an imaging or clinical arm. Radiographic or MRI evidence of sacroiliitis can be applied for the imaging arm. However, it is well-established that reliability and sensitivity of radiographic sacroiliitis is inadequate.Objectives:To assess the impact of replacing radiographic sacroiliitis with MRI structural lesions (MRI-S) typical of axSpA on the number of patients classified as having axSpA in patients with undiagnosed back pain recruited to the ASAS Classification Cohort (ASAS-CC).Methods:MRI images of the sacroiliac joint (SIJ) were available from 217 cases in the ASAS-CC, which also had clinical, laboratory, and radiographic data. Seven central readers from the ASAS-MRI group recorded MRI lesions in an eCRF that included active (MRI-A) and structural (MRI-S) lesions typical of axSpA. MRI-A was deemed to be present according to majority agreement (≥4/7) of central readers. MRI-S was deemed to be present according to the majority (majority reader MRI-S) and also according to at least 2 central readers (≥2-reader MRI-S). We calculated the number of patients that were classified differently after replacement of radiographs by MRI-S for overall fulfillment of the ASAS criteria and for the imaging arm.Results:In total, 119 (54.8%) cases fulfilled the axSpA criteria based on local reading of radiographic sacroiliitis and central reading of active inflammation on MRI. This changed to 125 (57.6%) and 118 (54.4%) of cases after replacement of radiographic sacroiliitis by ≥2-reader and majority reader MRI-S, respectively (Table). A total of 13 (6.0%) and 7 (3.2%) cases who were classified as not having axSpA were re-classified as having axSpA after replacing radiographic sacroiliitis with ≥2-reader and majority reader MRI-S, respectively. Conversely, 7 (3.2%) and 8 (3.7%) cases were re-classified as not having axSpA after substitution by ≥2-reader and majority reader MRI-S, respectively. When fulfillment of the imaging arm was the primary consideration (irrespective of the clinical arm), the number of patients reclassified from not axSpA to axSpA was 25 (11.5%) by ≥2-reader and 13 (6.0%) by majority reader MRI-S, while 8 (3.7%) and 11 (5.1%) were reclassified from axSpA to not axSpA.Conclusion:The number of patients classified as having axSpA does not change substantially when MRI-S replaces radiographic sacroiliitis. However, it remains possible that MRI structural lesions can influence the final diagnosis, the gold standard for assessment of the performance of the ASAS criteria.Impact of Replacement of Radiographic Sacroilitis by MRI Structural Lesions on SpA Classification in cases with all clinical, radiographic, and central and local MRI inflammation data available (n=217)MRI assessment usedSpA Classification=Yes N(%)SpA Classification=No N(%)Imaging Arm SpA Classification=Yes N(%)Imaging Arm SpA Classification=No N(%)Radiographic Sacroiliitis + Majority Central Reader MRI Inflammation Positive119 (54.8%)97 (44.7%)83(38.2%)134 (61.8%)Replace Radiographic Sacroiliitis with ≥2 Central Reader MRI Structural Positive125 (57.6%)92 (42.4%)100 (46.1%)117 (53.9%)Replace Radiographic Sacroiliitis with Majority Central Reader MRI Structural Positive118 (54.4%)99 (45.6%)85 (39.2%)132 (60.8%)Disclosure of Interests:Walter P. Maksymowych Grant/research support from: AbbVie, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited, Speakers bureau: AbbVie, Janssen, Novartis, Pfizer, and UCB, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Robert G Lambert: None declared, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Stephanie Wichuk: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Joel Paschke: None declared, Susanne Juhl Pedersen Grant/research support from: Novartis, Ulrich Weber: None declared
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Rios Rodriguez, V., M. Protopopov, F. Proft, J. Rademacher, B. Muche, A. K. Weber, S. Lüders, et al. "THU0401 IMPACT OF BODY COMPOSITION MEASURES ON THE RESPONSE TO BIOLOGICAL DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS IN PATIENTS WITH ANKYLOSING SPONDYLITIS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 438.2–438. http://dx.doi.org/10.1136/annrheumdis-2020-eular.6197.
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Background:Data on the impact of body weight and body mass index (BMI) on the response to biological disease-modifying anti-rheumatic drugs (bDMARDs) in axial spondyloarthritis (axSpA) including ankylosing spondylitis (AS) are still contradictory. Data on the impact of different components of the body composition on the treatment response are lacking.Objectives:To investigate the impact of body composition on the response to biological disease-modifying anti-rheumatic drugs (bDMARD) in patients with AS after 6 months of treatment.Methods:Patients with AS (radiographic axSpA), fulfilling the modified New York criteria and starting a bDMARD therapy were recruited between 2015 and 2019 in an extension of the prospective German Spondyloarthritis Inception Cohort (GESPIC-AS). All patients were required to be candidates for bDMARD therapy at baseline with high disease activity (BASDAI >=4 and/or ASDAS >=2.1) despite previous treatment with nonsteroidal anti-inflammatory drugs. Disease activity measures (BASDAI, CRP, ASDAS), as well as body composition parameters were assessed at baseline and after 6 months of bDMARD treatment. Body composition was assessed by the bioelectrical impedance analysis (BIA). Weight, body mass index (BMI), fat mass index (FMI), fat free mass index (FFMI), skeletal muscle mass value (SMM), visceral adipose tissue (VAT), total body water (TBW), and extracellular water (ECW) values were collected. The primary measure of the treatment response was ASDAS change at month 6 as compared to baseline.Results:A total of 129 patients with AS were included in this cohort. BIA was performed in 77 patients. There were 71.4% males, and 85.7% were HLA-B27 positive. At baseline, BASDAI was 5.4±1.4, CRP was 12.8±16.5 mg/l, and ASDAS - 3.0±1.0. The baseline BMI was 25.0±4.3 kg/m2. A total of 75 patients were treated with TNFi, 2 patients received an IL-17 inhibitor.A higher BMI at baseline was associated with a worse response to bDMARD therapy that was attributable to both, the fat mass as reflected by FMI and to the fat-free mass reflected by FFMI, but not to SMM or VAT or water components – Table. This effect was independent of age, sex, symptom duration, HLA-B27 status and ASDAS at baseline.Table.Univariable and multivariable linear regression analysis of the association between response to bDMARD treatment (change in the ASDAS score after 6 months) and body composition parameters in patients with AS (n=77)VariablesUnivariableMultivariable analysis*Analysisß (95%CI)Model 1ß (95%CI)Model 2ß (95%CI)Model 3ß (95%CI)Model 4ß (95%CI)Model 5ß (95%CI)Model 6ß (95%CI)Model 7ß (95%CI)BMI, kg/m2-0.016(-0.063; 0.031)-0.043(-0.079;-0.006)------FMI, kg/m2-0.024(-0.103; 0.054)--0.065(-0.128;-0.003)-----FMMI,kg/m2-0.010(-0.133; 0.112)---0.138(-0.253;-0.022)----SMM, kg0.026(-0.020; - 0.071)---0.012(-0.044; 0.069)---VAT, liters0.069(-0.099; 0.238)-----0.095(-0.248; 0.057)--TBW, liters0.020(-0.016; 0.056)-----0.007(-0.036; 0.051)-ECW, liters0.054(-0.43; 0.150)------0.005(-0.98; 0.107)*Adjusted for age, sex, HLA-B27 status, symptom duration, and ASDAS at baseline.BMI: Body Mass Index; FMI: Fat Mass Index; SMM: Skeletal Muscle mass; VAT: Visceral Adipose Tissue; AS: ankylosing spondylitis; bDMARD: biological disease-modifying anti-rheumatic drug; CI: 95% confidence interval.Conclusion:Both fat mass and fat free mass have an impact on the response to bDMARDs after 6 months of treatment in patients with AS. Interestingly, skeletal muscle mass, visceral fat as well as water components showed no association with treatment response.Acknowledgments:GESPIC has been financially supported by ArthroMark and METARTHROS projects.Disclosure of Interests: :Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Judith Rademacher: None declared, Burkhard Muche: None declared, Anne Katrin Weber: None declared, Susanne Lüders: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Maryna Verba: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Herrero Morant, A., G. Suárez Amorín, L. Sanchez Bilbao, C. Álvarez Reguera, D. Martínez-López, J. L. Martín-Varillas, P. Setien Preciados, et al. "AB1215 EPIDEMIOLOGY AND CLINICAL PHENOTYPE OF BEHÇET’S DISEASE IN A WELL-DEFINED POPULATION OF NORTHERN SPAIN." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1898.2–1899. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4694.
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Background:Considerable epidemiological variations in prevalence of Behçet’s disease (BD) have been reported. These disparities may either reflect geographical differences, methodological artifacts, changes over time or random fluctuations. In Spain, published BD’s epidemiological studies are scarce.Objectives:To study epidemiological and clinical domains of BD in a well-defined population of Northern Spain, as well as, to compare results with other regions.Methods:We included all consecutive 111 patients, diagnosed of definitive or possible BD by expert rheumatologists between 1980 and 2019. Two Classification criteria were applied: a) International Study Group (ISG) for BD(Lancet. 1990; 335:1078-80), and b) International Criteria for BD (ICBD)(J Eur Acad Dermatol Venereol. 2014; 28:338-47). In addition, a literature review of Medline publications was carried out.Results:In our study, prevalence was higher than in most European populations regardless of the diagnostic criteria applied. Incidence was low (expert opinion: 0.021, ICBD: 0.016, ISG: 0.012). Mean age at onset (36.8±13.2) and gender distribution (55.9% females) were similar to other countries. Pathergy test was performed in 9% of patients giving low results (25.2%). Clinical domains’ frequency was in line with other regions except vascular and gastrointestinal involvement, which were lower. (TABLE)Conclusion:BD’s prevalence in Northern Spain is higher than in most European populations. These differences likely reflect a combination of true geographic variation, methodological artifacts as well as the easy access to Public Health System and its efficiency. In contrast, clinical phenotypes are similar to other regions.TABLEDiagnostic criteria and study periodn cases / population sizeMean age at onset and sex (%females)Prevalence (over 100000) / incidenceOral / genital ulcers (%)Skin lessions/ pathergy test (%)Ocular involvement (%)Joint involvement (%)Neurobehcet/ Vascular/ Gastrointestinal involvement (%)Herrero, A et al. Southern Europe (Cantabria, Spain)Expert opinion, ISG, ICBD / 1980-2019111 (expert opinion) / 86 (ICBD) / 65 (ISG) / 58107836.8±13.2/ 55.919.1 (expert opinion), 14.8 (ICBD), 11.2 (ISG) / 0.021 (expert opinion), 0.016 (ICBD), 0.012 (ISG)99 / 53.168.4 / 25. 235.168.518 / 10 / 4.5Calamia, K. T. et al. North America (Minnesota, USA)ISG / 1960-200513 / NR31 / 305.2 / 0.38100 / 6285 / NR624623 / 23 / NRAltenburg, A. et al. Northern Europe (Berlin, Germany)ISG and ABD classification tree / 1961-2005590 / 339134426 / 584.9 / 1 (estimated)98.5 / 63.762.5 / 33.758.15310.9 / 22.7 / 11.6Mohammad, A. et al. Northern Europe (Skane County, Sweden)ISG / 1997-201040 / 80931730.5 / 334.9 / 0.2100 / 8088 / NR53400 / 20 / NRMahr, A. et al. Southern Europe (Seine-Saint-Denis County, France)ISG / 200379 / 109441227.6 / 437.1 / NR100 / 8090 / 20515910 / NR / 10Salvarani, C. et al. Southern Europe (Reggio Emilia, Italy)ISG, 1988-200518 / 48696133 / 503.7 / 0.24100 / 78100 / NR565011 / 6 / NRAzizlerli, G. et al. Middle East (Istambul, Turkey)ISG / prevalence study101 / 23986NR / 48.542 / NR100 / 70.2Not globally reported / 69.327.7Not globally reportedNR / Not globally reported / NRDavatchi, F. et al. Middle East (Iran nationwide)Expert opinion / 1975-20187641 / NR25.6 / 44.280 / NR97.5 / 64.462.2 / 50.455.638.13.9 / 8.9 / 6.8Krause, I. et al. Middle East (Galilee, Israel)ISG / 15 years (not specific years have been reported)112 / 73700030.6 / 4715.2 / NRNR / 6841 / 44.4587011.6 / Not globally reported / NRNishiyama, M. et al. Asia (Japan nationwide)1987 JCBD / 19913316 / NR35.7 / 50.6NR / NR98.2 / 73.287.1 / 43.869.156.911 / 8.9 / 15.5Disclosure of Interests:Alba Herrero Morant: None declared, Guillermo Suárez Amorín: None declared, Lara Sanchez Bilbao: None declared, Carmen Álvarez Reguera: None declared, David Martínez-López: None declared, José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Patricia Setien Preciados: None declared, M. Cristina Mata Arnaiz: None declared, Rosalía Demetrio-Pablo: None declared, Miguel Ángel Gordo Vega: None declared, Miguel Á. González-Gay Grant/research support from: AbbVie, MSD and Roche, Speakers bureau: AbbVie, MSD and Roche, Ricardo Blanco Grant/research support from: Abbvie, MSD and Roche, Consultant of: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen and MSD, Speakers bureau: Abbvie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD
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Jamaludin, A., R. Windsor, S. Ather, T. Kadir, A. Zisserman, J. Braun, L. S. Gensler, et al. "OP0060 MACHINE LEARNING BASED BERLIN SCORING OF MAGNETIC RESONANCE IMAGES OF THE SPINE IN PATIENTS WITH ANKYLOSING SPONDYLITIS FROM THE MEASURE 1 STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 40–41. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1207.
Full textAbstract:
Background:Magnetic resonance imaging (MRI) offers a non-invasive and objective method of early diagnosis and classification, monitoring disease burden and treatment response for patients (pts) with axial spondyloarthritis (axSpA) including ankylosing spondylitis (AS).1Numerous scoring schemes such as the AS Spine MRI Activity (ASspiMRIa) score are available for the quantitative assessment of MRI, but are subject to intra- and inter-rater variability, labor intensive and costly. Nevertheless, quantification of MRI changes has become an important tool to demonstrate treatment success of biologic drugs in axSpA.Objectives:To evaluate the performance of machine learning (ML) based software for automated Berlin grading of spinal MRI bone marrow oedema in pts with AS and compare with expert scoring.Methods:Fully automated ML software (Figure) was developed to detect and label 23 vertebrae, define vertebral units (VU) as per the Berlin modification of the ASspiMRIa score, and score each VU as either 0 (score of 0) or 1 (score of 1, 2 or 3). The ML algorithm was based on the previously developed SpineNet software.2Analysis included 108 pts from the secukinumab MEASURE 1 study3, in which imaging was done using T1 and STIR sagittal MRI at baseline and Weeks 16, 52, 104, 156 and 208. Two expert readers, blinded to treatment and visit, evaluated all images by ASspiMRIa score. The scores from Reader 2 (R2) were binned into two groups: 0 vs 1, 2, or 3. As a result of multiple pt time points and expert reading sessions, the complete dataset comprised of 10,988 VU. Ten-way cross-validation at per-VU was used to train and validate the ML software. The dataset was split into 10 randomly selected subsets, ensuring that each pt appears in only one subset, after which 8 subsets were used for training the ML software, 1 was used to check for correct training and 1 was used for validation. The process was repeated ten times such that all 10 subsets were used for validation. Accuracy weighted for the frequency of each category, sensitivity and specificity were calculated using scores from R2 as reference. Intra-reader accuracy was also calculated.Results:Accuracy of the software in relation to expert reader scores was 67% with a sensitivity of 0.63 and specificity of 0.70. The intra-reader accuracy was 71% and 77% for R1 and R2, respectively. Individual VU scoring of the Software vs. R2 are presented in the Table as a confusion matrix.Conclusion:Automated scoring of MR images in AS pts provided moderate agreement to that of expert reader-based assessments. ML software has potential to provide an automated guided-reading approach to scoring MR images, which may enable further clinical insights.References:[1]Lukas C, et al. J Rheumatol. 2007;34:862-70.[2]Jamaludin A, et al. Eur Spine J. 2017;26:1374-83.[3]Baeten D, et al. N Engl J Med. 2015;373,2534-48.Figure.Processing pipeline of automated Berlin scoring softwareTable.Confusion matrix between the software and R2SoftwareScore = 0SoftwareScore = 1, 2 or 3Total VU scoredR2 Score = 07199 (70%)3068 (30%)10,267R2 Score = 1, 2 or 3251 (35%)475 (65%)7267,4503,54310,993Percentages calculated as a fraction over the total in each row. Overall accuracy is the average of the highlighted percentages.Disclosure of Interests:Amir Jamaludin: None declared, Rhydian Windsor: None declared, Sarim Ather: None declared, Timor Kadir: None declared, Andrew Zisserman: None declared, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Pedro Machado Consultant of: Abbvie, Celgene, Janssen, Lilly, MSD, BMS, Novartis, Pfizer, Roche and UCB, Speakers bureau: AbbVie, Centocor, Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Thibaud Coroller Shareholder of: Novartis, Employee of: Novartis, Brian Porter Shareholder of: Novartis, Employee of: Novartis, Shephard Mpofu Shareholder of: Novartis, Employee of: Novartis, Aimee Readie Shareholder of: Novartis, Employee of: Novartis
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Proft, F., M. Torgutalp, A. Weiß, M. Protopopov, V. Rios Rodriguez, H. Haibel, K. Hermann, et al. "SAT0389 FREQUENCY OF DISEASE FLARES UNDER LONG-TERM ANTI-TNF THERAPY IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE ETANERCEPT VERSUS SULFASALAZINE IN EARLY AXIAL SPONDYLOARTHRITIS TRIAL." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1143–44. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3148.
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Background:Disease flares in axial spondyloarthritis (axSpA) might occur even in patients with otherwise stable disease receiving highly effective anti-inflammatory therapy such as TNF inhibitors. The frequency of disease flares, especially in patients with axSpA receiving long-term stable therapy, and factors associated with flares are not sufficiently investigated.Objectives:The objective was to assess the frequency of disease flares and to identify factors associated with flares in patients with early axSpA receiving continuous long-tem (up to 10 years) treatment with a TNF inhibitor etanercept.Methods:In the ESTHER (etanercept versus sulfasalazine in early axial spondyloarthritis trial), patients with early axSpA (symptom duration ≤5 years) were treated with ETN (n=40) versus sulfasalazine (n=36) for 48 weeks [2]. After one year all patients were treated continuously with etanercept (n=17 patients temporarily interrupted treatment in the 2nd year to assess time to flare and were then (re-)treated with etanercept, except 4 patients who completed the study in sustained remission) for up to 10 years in total. Only patients who were continuously treated with etanercept for at least 6 months were included in the current analysis. The disease flare was defined as a worsening of the ASDAS by ≥0.9 as compared to the value obtained at the previous visit. Univariate and multivariable cox-regression analyses were performed to analyze the predictors of flares.Results:Out of 76 patients who entered the study at baseline, 62 patients (n=32 with radiographic (r-) axSpA and n=30 with non-radiographic (nr-) axSpA) fulfilled the criterion of the continuous etanercept treatment. A total of 22 patients (35%) experienced at least one flare over the entire treatment period 10 patients (31.3%) in the r-axSpA and 12 patients (40%) in the nr-axSpA subgroup) - figure. A total of 81 flares occurred (33 and 48 in the r- and nr-axSpA subgroups, respectively) in the 10 years of follow-up. None of the documented disease flares resulted in a direct study withdrawal. The majority of flares occurred within first 4 years of treatment (figure). There were also no statistically significant differences between nr- and r-axSpA in the time until the first flare (p=0.4, Log-rank test). In the multivariable Cox regression analysis normal CRP values (≤5mg/l), HLA-B27 negativity, higher physician global assessment, a longer symptom duration at study entry, higher spinal ankylosis and higher fatty degeneration in the sacroiliac joints but lower spinal osteitis scores and lower ankylosis scores in the sacroiliac joints at baseline MRI were associated with a higher risk for flares.Conclusion:Disease flares according to the ASAS definition of clinically important worsening in axSpA based on ASDAS occurred ~1/3 of patients with early axSpA who received a treatment with etanercept for up to 10 years without major differences between r- and nr- forms of axSpA. HLA-B27 negativity, normal CRP, higher spinal ankylosis scores, higher fatty degeneration scores but lower ankylosis scores in the SIJ´s at baseline MRI were associated with a higher risk for flares.Figure 1.Baseline characteristics of all patients with with continous ETC treatment.all≥1 flareno flarepatientsn (%)62 (100)22 (35.5)40 (64.5)malen (%)38 (61.3)16 (72.7)22 (55)agemean (SD)34.1 (8.3)32.6 (7.8)35 (8.6)BASDAImean (SD)2.7 (2)1.8 (1.8)3.2 (1.9)ASDASmean (SD)1.6 (0.8)1.3 (0.7)1.7 (0.8)Figure 2.Kaplan-Meier curves indicating time to first flare and flare free survival propability.Acknowledgments:The ESTHER study was supported by an unrestricted research grant from Pfizer. Murat Torgutalp’s (MT) work at Charité - Universitätsmedizin was supported by an award from the Scientific and Technological Research Council of Turkey (TUBITAK).Disclosure of Interests:Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Murat Torgutalp: None declared, Anja Weiß: None declared, Mikhail Protopopov Consultant of: Novartis, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Kay Hermann: None declared, Christian Althoff: None declared, Olaf Behmer Employee of: Pfizer Pharma GmbH, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Rios Rodriguez, V., M. Protopopov, F. Proft, J. Rademacher, B. Muche, A. K. Weber, S. Lüders, et al. "FRI0292 TREATMENT RESPONSE TO BIOLOGICAL DISEASE-MODIFYING ANTI-RHEUMATIC DRUGS IS ASSOCIATED WITH FAVORABLE CHANGES OF THE BODY COMPOSITION IN PATIENTS WITH ANKYLOSING SPONDYLITIS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 734.1–735. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3868.
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Background:There is few data available regarding differences in body composition and its possible changes in patients with ankylosing spondylitis (AS) treated with biological disease-modifying anti-rheumatic drugs (bDMARDs). An increase of body weight and lean mass in patients receiving TNF inhibitors, as well as a possible muscle wasting by high disease activity have been previously described. Bioelectrical impedance analysis (BIA) is a valid method to assess body composition and allows to distinguish between fat, fat-free mass and skeletal muscle mass.Objectives:To evaluate changes in body composition in patients with AS after 6 months of treatment with bDMARDs.Methods:Patients with a diagnosis of AS, fulfilling the modified New York criteria and starting a bDMARD therapy were included in the extension of the prospective German Spondyloarthritis Inception Cohort (GESPIC). All patients had high disease activity (BASDAI >=4 and/or ASDAS >=2.1) despite previous treatment with nonsteroidal anti-inflammatory drugs. Disease activity and body composition were assessed at baseline and after 6 months of bDMARD treatment. Body composition was assessed by the BIA with the seca© mBCA 515 device (SECA Deutschland GmbH, Hamburg/Germany) and included the following parameters: weight, body mass index (BMI), fat mass index (FMI), fat free mass index (FFMI), skeletal muscle mass value (SMM), and visceral adipose tissue value (VAT). Response to a bDMARD therapy was defined as achievement of clinically important improvement of ASDAS (>=1.1).Results:A total of 129 patients (66.7% male) with AS were recruited in this cohort extension between 2015 and 2019. The mean (mean ± SD) age was 36.2 ± 10.3 years, and symptom duration was 10.7 ± 9.1 years. HLA-B27 test was positive in 89.1% patients. BIA was assessed in 77 patients; the baseline characteristics of these patients were similar to those of the whole cohort. Of these, 75 patients were treated with TNF inhibitors and 2 patients were treated with an IL-17A inhibitor.After 6 months of a bDMARD treatment, body composition changed significantly with an increase of weight and BMI due to the gain of FMI but also of FFMI and SMM, while there was no increase of the visceral fat – table. In responders (improvement of ASDAS>=1.1 after 6 months) the results were similar to the whole group with a significantly gain (mean±SD) on BMI, FMI, FFMI and SMM (0.3 ± 1.4 kg/m2, 0.3 ± 1.0 kg/m2, 0.2 ±0.5 kg/m2, 0.5 ± 1.2 kg, p<0.05, respectively). In non-responders, there were no significant changes on the body composition after 6 months of treatment.Conclusion:Treatment with bDMARDs is associated with favorable changes of the body composition with increase of the muscle mass but not of the visceral fat. These changes were evident in treatment responders only.TABLE 1.Body composition parameter at baseline and after 6 months of treatment with a bDMARDs in patients with AS (n=77)Mean±SDDifference, mean±SD95% CIP*LowerUpperWeight at baseline, kg77.19±15.710.75±3.800.041.470.04Weight at 6 months, kg77.94±16.25BMI at baseline, kg/m225.03±4.320.30±1.290.060.550.02BMI at 6 months, kg/m225.33±4.43FMI at baseline, kg/m26.74±3.390.31±0.970.070.540.01FMI at 6 months, kg/m27.05±3.42FFMI at baseline, kg/m218.27±2.180.15±0.480.040.270.01FFMI at 6 months, kg/m218.42±2.27SMM at baseline, kg27.40±5.850.32±1.110.050.590.02SMM at 6 months, kg27.73±5.90VAT at baseline, liters1.94±1.62-0.12±0.63-0.270.040.14VAT at 6 months, liters1.82±1.56BMI: Body Mass Index; FMI: Fat Mass Index; FFMI: Free Fat Mass Index; SMM: Skeletal Muscle mass; VAT: Visceral Adipose Tissue.*Wilcoxon testAcknowledgments:GESPIC has been financially suported by ArthroMark and METARTHROS projectsDisclosure of Interests:Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Judith Rademacher: None declared, Burkhard Muche: None declared, Anne Katrin Weber: None declared, Susanne Lüders: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Maryna Verba: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Rios Rodriguez, V., M. Protopopov, F. Proft, S. Lüders, J. Rademacher, H. Haibel, M. Verba, et al. "FRI0323 THE PRESENCE OF SPONDYLOARTHRITIS IS ASSOCIATED WITH HIGHER CLINICAL DISEASE ACTIVITY IN PATIENTS WITH EARLY CROHN’S DISEASE: RESULTS OF A PROSPECTIVE COHORT STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 753–54. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4178.
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Background:Inflammatory bowel disease (IBD) and specifically Crohn’s disease (CD) is known to be associated with spondyloarthritis (SpA). However, only little is known about factors associated with the development of spondyloarthritis in CD.Objectives:To identify factors associated with the presence of SpA in a cohort of patients with CD.Methods:Patients with a definite diagnosis of CD naïve to or not being treated with biological agents for at least 3 months were included in a CD-arm of the German Spondyloarthritis Inception Cohort (GESPIC-Crohn). Gastroenterologists were encouraged to include consecutively recently diagnosed CD patients. Patients were classified according to the Montreal classification including location and behavior of CD. Patients received a structured assessment of SpA manifestations (including magnetic resonance imaging of sacroiliac joints and spine) by a rheumatologist who was responsible for the final diagnosis of SpA / no SpA. Clinical activity of CD was assessed by the Harvey-Bradshaw Index (HBI). In addition, colonoscopy was performed, Simple endoscopic Score for Crohn’s Disease (SES-CD) was determined and fecal calprotectin was measured.Results:A total of 108 patients with CD were enrolled. The mean (mean ± SD) age was 36.6 ± 12.7 years, and CD symptom duration was 5.3 ± 7.4 years. At baseline, 44 (40.7%) patients were treated with non-biologic immunomodulating drugs: 16 (14.8%) patients received mesalazine, 27 (25.0%) azathioprine, and 1 (0.9%) methotrexate. Oral steroids were given to 38 (35.2%) patients. A total of 103 (96.3%) patients were biologics naïve. SpA was diagnosed in 23 (21.3%) patients: 12 had axial SpA and 11 peripheral SpA. Patients with SpA had higher prevalence of HLA-B27, of clinical SpA features (back pain, inflammatory back pain, peripheral arthritis, enthesitis), higher level of CRP and higher activity of CD as measured by the HBI. There were not substantial differences between SpA vs. non-SpA patients in terms of CD duration, endoscopic activity, disease location or behavior, or treatment, except for mesalazine, which was more frequently administered in patients with SpA than non-SpA (39.1% vs. 8.2%, p=0.001, respectively).Conclusion:SpA was present in 21% of patients with CD in this early cohort with almost equal proportions of axial and peripheral forms. Presence of HLA-B27 and higher clinical activity of CD were associated with the presence of SpA.TABLE.Baseline demographic and clinical characteristics of the included patients with Crohn’s disease with or without spondyloarthritis.VARIABLETOTALn=108SpAn=23No SpAn=85PAge, years, mean ± SD36.6 ± 12.737.5 ± 11.336.3 ± 13.10.44Male sex, n (%)50 (46.3)10 (43.5)40 (47.1)0.82CD symptom duration, years, mean ± SD5.3 ± 7.45.4 ± 7.25.1 ± 7.50.63HLA-B27 positive, n (%)13 (12.0)6 (26.1)7 (8.2)0.03Montreal classification Location: L1 - ileal68 (63.0)13 (56.5)55 (64.7)0.48 L2 - colonic000 L3 - ileocolonic39 (36.1)7 (30.4)32 (37.6)0.63 L4 – isolated upper disease10 (9.3)3 (13.0)7 (8.2)0.44Behavior:B1 – non-stricturing, non-penetrating69 (63.9)15 (65.2)54 (63.5)1.00 B2 - stricturing19 (17.6)4 (17.4)15 (17.6)1.00 B3 - penetrating6 (5.6)06 (7.1)0.34 Peri-anal disease7 (6.5)2 (8.7)5 (5.9)0.64 C-reactive protein, mg/l, mean ± SD10.7 ± 24.813.6 ± 23.210.0 ± 25.30.02 Harvey-Bradshaw Index, mean ± SD3.6 ± 4.05.5 ± 4.73.1 ± 3.60.01 Fecal calprotectin, mcg/d, mean ± SD185.9 ± 213.7211.7 ± 243.8179.5 ± 207.90.43Treatment of CD Mesalazine, n (%)16 (14.8)9 (39.1)7 (8.2)0.001 Methotrexate, n (%)27 (25.0)3 (13.0)24 (28.2)0.18 Azathioprine, n (%)1 (0.9)01 (1.2)1.00 Biologics naive, n (%)103 (96.3)22 (95.7)81 (96.4)1.00Disclosure of Interests:Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Mikhail Protopopov Consultant of: Novartis, Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Susanne Lüders: None declared, Judith Rademacher: None declared, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Maryna Verba: None declared, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Elena Sonnenberg: None declared, Michael Schumann: None declared, Lea Isabell Kredel: None declared, Britta Siegmund Consultant of: Abbvie, Boehringer, Celgene, Falk, Janssen, Lilly, Pfizer, Prometheus, Takeda, Speakers bureau: Abbvie, CED Service GmbH, Falk, Ferring, Janssen, Novartis, Takeda (BS served as representative of the Charité), Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Proft, F., M. Torgutalp, A. Weiß, M. Protopopov, V. Rios Rodriguez, H. Haibel, O. Behmer, J. Sieper, and D. Poddubnyy. "AB0660 LONG-TERM CLINICAL OUTCOME OF ANTI-TNF TREATMENT IN PATIENTS WITH EARLY AXIAL SPONDYLOARTHRITIS: 10-YEAR DATA OF THE ETANERCEPT VS. SULFASALAZIN IN EARLY AXIAL SPONDYLOARTHRITIS TRIAL." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1625.1–1625. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3136.
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Background:Long-term data on anti-TNF treatment in patients with early axial spondyloarthritis (SpA) is scarce.Objectives:The objective of this analysis was to assess the long-term clinical efficacy (up to 10 years of treatment) of a tumor necrosis factor (TNF) inhibitor etanercept (ETN) in patients with early axial spondyloarthritis, who participated in the long-term (until year 10) extension of the ESTHER (Etanercept vs. Sulfasalazine in Early Axial Spondyloarthritis Trial) trial.Methods:In the previously reported ESTHER trial, patients with early active axial SpA [including both non-radiographic axial SpA (nr-axSpA) and radiographic axial SpA (r-axSpA)/ankylosing spondylitis (AS)] with a symptom duration of <5 years and a positive MRI of the sacroiliac joints (SIJs) and/or the spine at baseline) were treated with ETN (n= 40) or sulfasalazine (SSZ) (n= 36) during the first year (1). At year 1, all patients who were not in remission continued with - or switched (in case of SSZ therapy) to – ETN for up to 10 years in total (1). Patients in remission discontinued their therapy and were followed-up until end of year 2; in case of remission loss, ETN was (re)-introduced and continued till the end of year 10.Results:Out of 76 initial patients, 25% (n=19, 12 with r-axSpA and 7 with nr-axSpA) completed year 10 of the study. At baseline, completers were significantly more often male and showed lower values of patient (PGA) and physician global assessments of disease activity (PhGA), ASDAS (Ankylosing Spondylitis Disease Activity Score), BASMI (Bath Ankylosing Spondylitis Metrology Index), and AS-QoL (Ankylosing Spondylitis Quality of Life Questionnaire) as compared to non-completers (Table 1). When analyzing clinical data of the completers, mean BASDAI, BASFI and ASDAS values were constantly <2 during the follow up with no statistically significant differences between the r-axSpA and nr-axSpA sub-groups (Table 2, Figure 1B). In the entire group, a sustained clinical response was observed over 10 years of follow up (Figure 1A). A total of 39 serious adverse events were documented over the 10 years of the study, while six of them were seen as possibly associated with ETN treatment, which lead in five patients (one lymphoma, one sarcoidosis, one demyelinating neurological disease, one elevated liver enzymes and one recurrent minor infections) to an ETN discontinuation.Conclusion:A sustained clinical response was shown over the 10 years of the study for the completers with comparable rates between r-axSpA and nr-axSpA. ETN was well tolerated across the entire treatment period and showed a good safety profile with no new safety signals.Table 1.Baseline characteristics of patients with axial spondyloarthritis who completed the study as compared to patients who dropped out.Completer(n=19)Non-Completer(n=57)p valueAge, years32.5 (7.4)32.8 (8.9)0.91Male patients, n (%)15 (78.9)29 (50.9)0.034Symptomduration, years1.1 (1.2)1 (1.7)0.81HLA-B27 positivity, n (%)18 (94.7)44 (77.2)0.091Elevated CRP (CRP>5mg/l), n (%)7 (38.9)33 (62.3)0.088Fulfilled New York criteria, n (%)12 (63.2)27 (47.4)0.24Patient global (0-10)6.1 (1.9)7.2 (1.7)0.025Physician global (0-10)5.5 (1.5)6.5 (1.2)0.007ASDAS3 (0.7)3.5 (0.8)0.042BASDAI (0-10)5.4 (1.1)5.8 (1.3)0.27BASFI (0-10)4 (2.1)4.4 (2)0.41BASMI (0-10)1.2 (1.3)2 (1.6)0.039AS-QoL (0-18)7.6 (3.9)10.1 (3.9)0.019Acknowledgments:The ESTHER study was supported by an unrestricted research grant from Pfizer.Murat Torgutalp’s work at Charité was supported by an award from the Scientific and Technological Research Council of Turkey.Disclosure of Interests:Fabian Proft Grant/research support from: Novartis Pharma GmbH, Consultant of: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: Consultancy / speaker fees from: Abbvie, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Murat Torgutalp: None declared, Anja Weiß: None declared, Mikhail Protopopov Consultant of: Novartis, Valeria Rios Rodriguez Consultant of: Abbvie, Novartis, Hildrun Haibel Consultant of: Abbvie, Jansen, MSD, and Novartis, Speakers bureau: Abbvie, Jansen, MSD, and Novartis, Olaf Behmer Employee of: Pfizer Pharma GmbH, Joachim Sieper Consultant of: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Speakers bureau: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, and UCB Pharma, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Garnier, M., B. Marc, F. Zkhiri, B. Richard, F. Boubrit, and M. Soutoul. "Illicit drugs use among detainees seen at the Emergency Forensic Unit of Seine-Saint Denis department (North East Paris suburb), year 1994. Results of OnTrak® Roche drug detection kits urinary screening." Journal of Clinical Forensic Medicine 2 (March 1995): 3. http://dx.doi.org/10.1016/1353-1131(95)90112-4.
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Sanchez-Bilbao, L., G. Suárez-Amorín, C. Álvarez-Reguera, A. Herrero-Morant, D. Martínez-López, J. L. Martín-Varillas, M. C. Mata Arnaiz, R. Demetrio-Pablo, M. A. González-Gay, and R. Blanco. "AB0399 EPIDEMIOLOGY OF BEHÇET DISEASE IN A NORTHERN SPANISH HEALTH REGION." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1227.2–1228. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3577.
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Background:Behçet disease (BD) is a systemic and potentially severe disease. Its incidence varies widely worldwide. In Spain, published BD’s epidemiological studies are scarce.Objectives:In a well-defined Northern Spanish population-based cohort, the aim of this study was a) to estimate epidemiological variations, b) clinical domains and c) to compare our results with other regions.Methods:Study of unselected all consecutive patients diagnosed with definitive or possible BD by expert rheumatologists between 1980 and 2020 in our health region. Two classification criteria were applied: a) International Study Group (ISG) for BD [1], and b) International Criteria for BD (ICBD) [2]. In addition, a literature review of Medline publications was carried out.Results:In this study, from a total of 120 patients diagnosed with BD by expert opinion (58 women/62 men), 96 met ICBD and 59 ISG criteria. Mean age of the cohort at diagnosis was 37.6±13.8 years similar to other countries, as well as sex distribution.Prevalence was higher than in most European populations regardless the diagnostic criteria applied: expert opinion (20.6), ICBD (16.5) or ISG (10.1) (TABLE 1). Incidence was lower (expert opinion: 0.022, ICBD: 0.018, ISG: 0.011). Clinical domains’ frequency was in line with other regions except vascular and gastrointestinal involvement, which were lower.TABLE 1.Diagnostic criteria and study periodn cases / population sizeMean age at onset and sex (%female)Prevalence (over 100000) / incidenceOral / genital ulcers (%)Skin lessions/ pathergy test (%)Ocular involve ment (%)Joint involve ment (%)Neurobehcet/ Vascular/ Gastrointestinalinvolvement (%)Sánchez. L et al. Southern Europe (Cantabria, Spain)Expert opinion, ISG, ICBD / 1980- 2020120 (expert opinion) / 96 (ICBD) / 59 (ISG) / 58164137.6 ±13.8/ 48.320.6 (expert opinion), 16.5 (ICBD), 10.1 (ISG) / 0.022 (expert opinion), 0.018 (ICBD), 0.011 (ISG)94.2 / 59.263.3 / 25. 241.66510.8 / 11.6 / 6.6Calamia, K. T. et al. North America (Minnesota, USA)ISG / 1960-200513 / NR31 / 305.2 / 0.38100 / 6285 / NR624623 / 23 / NRAltenburg, A. et al. Northern Europe (Berlin, Germany)ISG and ABD classification tree / 1961-2005590 / 339134426 / 584.9 / 1 (estimated)98.5 / 63.762.5 / 33.758.15310.9 / 22.7 / 11.6Mohammad, A. et al. Northern Europe (Skane County, Sweden)ISG / 1997-201040 / 80931730.5 / 334.9 / 0.2100 / 8088 / NR53400 / 20 / NRMahr, A. et al. Southern Europe (SeineSaint-Denis County, France)ISG / 200379 / 109441227.6 / 437.1 / NR100 / 8090 / 20515910 / NR / 10Salvarani, C. et al. SouthernEurope (Reggio Emilia, Italy)ISG, 1988-200518 / 48696133 / 503.7 / 0.24100 / 78100 / NR565011 / 6 / NRAzizlerli, G. et al. Middle East (Istambul, Turkey)ISG / prevalence study101 / 23986NR / 48.542 / NR100 / 70.2Not globally reported / 69.327.7Not globally reportedNR / Not globally reported / NRDavatchi, F. et al. Middle East (Iran nationwide)Expert opinion / 1975-20187641 / NR25.6 / 44.280 / NR97.5 / 64.462.2 / 50.455.638.13.9 / 8.9 / 6.8Krause, I. et al. Middle East (Galilee, Israel)ISG / 15 years (not specific years have been reported)112 / 73700030.6 / 4715.2 / NRNR / 6841 / 44.4587011.6 / Not globally reported / NRNishiyama, M. et al. Asia (Japan nationwide)1987 JCBD / 19913316 / NR35.7 / 50.6NR / NR98.2 / 73.287.1 / 43.869.156.911 / 8.9 / 15.5JCBD: Japanese diagnostic Criteria of Behçet’s Disease; n: number of cases; NR: Not ReportedConclusion:BD’s prevalence in Northern Spain is higher than in most European populations. These differences likely reflect a combination of true geographic variation, methodological artifacts as well as the easy access to Public Health System and its efficiency. In contrast, clinical phenotypes are similar to other regions.References:[1]Lancet. 1990; 335:1078-80[2]J Eur Acad Dermatol Venereol. 2014; 28:338-47Disclosure of Interests:Lara Sanchez-Bilbao: None declared, Guillermo Suárez-Amorín: None declared, Carmen Álvarez-Reguera: None declared, Alba Herrero-Morant: None declared, David Martínez-López: None declared, José Luis Martín-Varillas: None declared, M. Cristina Mata Arnaiz: None declared, Rosalía Demetrio-Pablo: None declared, Miguel A González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Celgene and MSD., Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly and MSD., Grant/research support from: AbbVie, MSD and Roche.
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Braun, J., R. Blanco, E. Dokoupilova, L. S. Gensler, A. Kivitz, S. Hall, H. Kameda, et al. "OP0106 SECUKINUMAB 150 MG SIGNIFICANTLY IMPROVED SIGNS AND SYMPTOMS OF NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: 52-WEEK RESULTS FROM THE PHASE III PREVENT STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 69–70. http://dx.doi.org/10.1136/annrheumdis-2020-eular.598.
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Background:Axial spondyloarthritis (axSpA) spectrum covers radiographic axSpA and non-radiographic axSpA (nr-axSpA). PREVENT (NCT02696031) is the first phase III, placebo (PBO) controlled study evaluating secukinumab (SEC) 150 mg with (LD) or without loading (NL) dose, in patients (pts) with nr-axSpA.1The study had 2 independent analysis plans as per EU (Wk 16) and US (Wk 52) regulatory requirements.Objectives:To report efficacy through Wk 52 and safety up to two years for the PREVENT study.Methods:555 pts fulfilling ASAS criteria for axSpA plus abnormal CRP and/or MRI, without evidence of radiographic changes in sacroiliac (SI) joints according to modified New York Criteria for AS were enrolled. All images were assessed centrally before inclusion. Pts were randomised (1:1:1) to SEC 150 mg with LD, NL, or PBO at baseline (BL). LD pts received SEC 150 mg at Wks 1, 2, 3, and 4, and then every 4 wks (q4wk) starting at Wk 4. NL pts received SEC 150 mg at BL and PBO at Wks 1, 2, and 3, and then 150 mg q4wk. Switch to open-label (OL) SEC 150 mg or standard of care (SoC) was permitted after Wk 20. Primary endpoint was ASAS40 at Wk 16 (LD) and at Wk 52 (NL) in anti-TNF-naïve pts. Secondary endpoints (overall population) included ASAS40, BASDAI50, SI joint bone marrow edema (BME) score by MRI at Wks 16 and 52 and ASDAS-CRP inactive disease (ID) at Wk 52. Endpoints were analysed according to statistical hierarchy. Analysis used non responder imputation through Wk 52. Safety analyses included all pts who received ≥1 dose of study treatment.Results:Overall, 481 pts completed 52 wks with no major differences in retention across groups: 84.3% (156/185; LD), 89.7% (165/184; NL) and 86.0% (160/186; PBO). BL characteristics were similar across groups; 90% pts were anti-TNF-naïve, 56-58% pts had elevated CRP, 71-75% pts had evidence of SI joint inflammation by MRI. Proportion of pts who switched to OL or SoC between Wks 20 and 48 was 52.1% (LD), 49.2% (NL), and 67.4% (PBO). Primary endpoints at Wk 16 and Wk 52 were met (Table). SEC 150 mg LD or NL significantly improved secondary endpoints at Wk 16 and 52 vs PBO (Table). SEC significantly reduced SI joint MRI BME score vs PBO at Wk 16 (-1.68 and -1.03 vs -0.39;P= 0.0197 and 0.026, LD and NL respectively). No unexpected safety signals were reported.Conclusion:SEC 150 mg provided significant and sustained improvement in signs and symptoms of pts with nr-axSpA through Wk 52. MRI BME scores were reduced accordingly. There was no major difference between LD and NL. Safety of SEC was consistent with previous reports.2References:[1]Deodhar A, et al.Arthritis Rheumatol. 2019;71(suppl 10).[2]Deodhar A, et al. Arth Res Ther. 2019;21:111.TableEndpoints, % respondersWkSEC150 mg LD(N = 185)SEC150 mg NL(N = 184)PBO(N = 186)PrimaryASAS40 in anti-TNF-naïve pts1641.5‡42.2‡29.25235.4‡39.8‡19.9SecondaryASAS401640.0‡40.8‡28.05233.5‡38.0‡19.4BASDAI501637.3‡37.5‡21.05230.8‡35.3‡19.9ASDAS-CRP ID1620.5†21.7†8.15215.723.9‡10.2†P< 0.001;‡P< 0.05 vs PBO (Pvalues are adjusted for multiplicity of testing at Wks 16 and 52. UnadjustedPvalue for ASDAS-CRP ID at Wk 16). Missing values were imputed as non-response.N, number of randomised ptsDisclosure of Interests:Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Ricardo Blanco Grant/research support from: AbbVie, MSD, Roche, Consultant of: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma and MSD, Speakers bureau: Abbvie, Eli Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma. MSD, Eva Dokoupilova Grant/research support from: Eli Lilly, AbbVie, Novartis, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Alan Kivitz Shareholder of: AbbVie, Amgen, Gilead, GSK, Pfizer Inc, Sanofi, Consultant of: AbbVie, Boehringer Ingelheim, Flexion, Genzyme, Gilead, Janssen, Novartis, Pfizer Inc, Regeneron, Sanofi, SUN Pharma Advanced Research, UCB, Paid instructor for: Celgene, Genzyme, Horizon, Merck, Novartis, Pfizer, Regeneron, Sanofi, Speakers bureau: AbbVie, Celgene, Flexion, Genzyme, Horizon, Merck, Novartis, Pfizer Inc, Regeneron, Sanofi, Stephen Hall Grant/research support from: Abbvie, UCB, Janssen, Merck, Hideto Kameda Grant/research support from: Abbvie, Asahi-Kasei, Chugai, Eisai, Mitsubishi-Tanabe and Novartis, Consultant of: Abbvie, Boehringer, Celgene, Eli Lilly, Janssen, Novartis, Sanofi, UCB, Speakers bureau: Abbvie, Asahi-Kasei, BMS, Chugai, Eisai, Eli Lilly, Janssen, Mitsubishi-Tanabe, Novartis and Pfizer, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Marleen van de Sande Grant/research support from: Novartis, Eli Lilly, Boehringer Ingelheim, Janssen, Consultant of: Abbvie, Novartis, Eli Lilly, Speakers bureau: Novartis, MSD, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Anna Wiksten Shareholder of: Novartis, Employee of: Novartis, Brian Porter Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis, Employee of: Novartis, Sibylle Haemmerle Shareholder of: Novartis, Employee of: Novartis, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB
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Sparfel, M. A., S. Derolez, J. Law-Wan, N. Azzopardi, P. Goupille, D. Mulleman, and T. Bejan-Angoulvant. "POS0636 INFLUENCE OF DEMOGRAPHIC AND DISEASE RELATED FACTORS ON EFFICACY OF INFLIXIMAB OR GOLIMUMAB IN RHEUMATOID ARTHRITIS. A META-ANALYSIS ON RANDOMIZED PLACEBO- CONTROLLED TRIALS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 556.1–556. http://dx.doi.org/10.1136/annrheumdis-2021-eular.3565.
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Background:TNF inhibitors have changed the course of rheumatoid arthritis (RA). Yet, detailed analysis on factors influencing clinical response to TNF inhibitors in RA is lacking.Objectives:Herein we aimed at studying the impact of demographics and disease-related factors on therapeutic response to golimumab and infliximab in RA.Methods:Randomized clinical trials (RCTs) that evaluated golimumab and infliximab versus placebo or conventional therapy were sought. We selected the following factors: age, sex, ethnicity, body mass index (BMI), smoking status, physical activity, disease duration, disease activity at baseline, presence of auto-antibodies. We studied the impact of these factors on clinical response using firstly aggregate data in a Mantel-Haenszel random effects model, and secondly individual data in a multivariate regression model.Results:Individual data from 8 RCTs, 2 on infliximab (n=1477) and 6 on golimumab (total =3041) were obtained. In the aggregate model analysis, none of the selected factors had a significant impact on clinical response. In the multivariate analysis, male sex and physical activity were significantly associated with a lower DAS28-CRP after 6 months of treatment (regression coefficients -0.264 (p<0.001) and -0.193 (p=0.004) respectively), while a high initial DAS28-CRP was significantly associated with a higher DAS28-CRP (regression coefficient 0.579 (p<0.001)). The baseline disease activity was the only significant interaction factor with the effect of the treatment.Conclusion:Male gender and practicing physical activity are associated with lower disease activity 6 months after golimumab or infliximab initiation. High baseline disease activity significantly influences negatively the effect of the treatment on disease activity score.Acknowledgements:This study, carried out under YODA Project 2018-2931, used data obtained from the Yale University Open Data Access Project, which has an agreement with JANSSEN RESEARCH & DEVELOPMENT, L.L.C. The interpretation and reporting of research using this data are solely the responsibility of the authors and does not necessarily represent the official views of the Yale University Open Data Access Project or JANSSEN RESEARCH & DEVELOPMENT, L.L.C.Disclosure of Interests:Marc-Antoine SPARFEL: None declared, Sophie Derolez: None declared, Johan Law-Wan: None declared, Nicolas Azzopardi: None declared, Philippe Goupille Speakers bureau: Abbvie, Biogaran, BMS, Hospira, Janssen, MSD, Pfizer, Sanofi-Genzyme, UCB, Consultant of: Abbvie, Biogaran, BMS, Hospira, Janssen, MSD, Pfizer, Sanofi-Genzyme, UCB, Grant/research support from: Clinical trials sponsored by Abbvie, Roche, BMS, Boehringer, Lilly, Novartis, Pfizer, UCB, Janssen and MSD. Invitation to an international congresses by MSD, Roche, BMS and Abbvie, Denis Mulleman Speakers bureau: Pfizer and Novartis, Consultant of: Pfizer and Novartis, Grant/research support from: Invitation to an international congress by Janssen-Cilag, Theodora Bejan-Angoulvant: None declared
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Van den Bosch, F., D. Poddubnyy, J. Stigler, A. Ostor, S. D’angelo, V. Navarro-Compán, I. H. Song, T. Gao, F. Ganz, and L. S. Gensler. "POS0923 INFLUENCE OF BASELINE DEMOGRAPHICS ON IMPROVEMENTS IN DISEASE ACTIVITY MEASURES IN PATIENTS WITH ANKYLOSING SPONDYLITIS RECEIVING UPADACITINIB: A POST HOC SUBGROUP ANALYSIS OF SELECT-AXIS 1." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 722.2–723. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1975.
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Background:Upadacitinib (UPA), an oral Janus kinase inhibitor, has demonstrated efficacy and safety through 14 weeks in the SELECT-AXIS 1 study in biologic disease-modifying antirheumatic drug-naïve patients with active ankylosing spondylitis (AS).1Objectives:To evaluate the efficacy of UPA 15 mg once daily (QD) in selected subgroups of patients with AS based on different baseline characteristics.Methods:In SELECT-AXIS 1, patients were randomized to 14 weeks of blinded treatment with UPA 15 mg QD or placebo (PBO). This post hoc analysis evaluated the proportions of patients achieving ≥40% improvement in Assessment of SpondyloArthritis International Society criteria (ASAS40), ≥50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), and change from baseline in Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS[CRP]) at Week 14 across subgroups based on the following baseline patient characteristics: gender, age, body mass index, AS symptom duration, C-reactive protein (CRP) levels, Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging index, and human leukocyte antigen B27 status. For missing data, non-responder imputation analysis was used for ASAS40 and BASDAI50, and mixed model repeated measures analysis was used for ASDAS(CRP).Results:Baseline disease characteristics were balanced between the treatment groups at randomization, as previously reported.1 ASAS40 and BASDAI50 response rates at Week 14 were numerically higher with UPA 15 mg versus PBO across the demographic and disease characteristic subgroups evaluated (Figure 1), including some subgroups with small sample sizes, such as patients with disease duration <5 years and female patients. Improvements from baseline in ASDAS(CRP) were also consistently greater with UPA 15 mg versus PBO across the subgroups evaluated (Table 1).Conclusion:Within subgroups evaluated, most patients with active AS receiving UPA 15 mg demonstrated greater improvements versus PBO in disease activity measures assessed by ASAS40, BASDAI50, and change from baseline in ASDAS(CRP). There was some evidence that gender, AS symptom duration, and baseline CRP levels seemed to influence outcomes, though results should be interpreted with caution due to small sample sizes for some subgroups.References:[1]van der Heijde D, et al. Lancet 2019;394:2108–17.Table 1.PBO-corrected mean change from baseline (95% CI) in ASDAS(CRP) at Week 14 in patients receiving UPA 15 mg by baseline subgroups (MMRM)nASDAS(CRP)SubgroupUPA15 mgPBOPBO-corrected mean change from baseline (95% CI)GenderMale5862–1.11 (–1.37, –0.84)Female2622–0.44 (–0.92, 0.03)Age<40 years2436–1.00 (–1.42, –0.58)40–<65 years5146–0.88 (–1.17, –0.59)Body mass index<25 kg/m23237–0.92 (–1.30, –0.55)≥25 kg/m25247–0.89 (–1.20, –0.59)AS symptom duration<5 years1617–0.90 (–1.46, –0.34)≥5 years6867–0.92 (–1.18, –0.66)Baseline hsCRP≤2.8 mg/L2319–0.59 (–1.02, –0.15)>2.8–<10 mg/L3934–0.59 (–0.95, –0.23)≥10 mg/L2231–1.64 (–2.01, –1.27)Inflammation based on SPARCC MRI scoresPositivea5657–0.98 (–1.27, –0.69)Negativeb2116–0.60 (–1.08, –0.12)HLA-B27 statusPositive6266–0.97 (–1.24, –0.71)Negative2017–0.73 (–1.28, –0.17)aSpine SPARCC score ≥2 or sacroiliac joint SPARCC score ≥2. bSpine SPARCC score <2 and sacroiliac joint SPARCC score <2ASDAS(CRP), Ankylosing Spondylitis Disease Activity Score with C-reactive protein; CI, confidence interval; HLA-B27, human leukocyte antigen B27; hsCRP, high-sensitivity C-reactive protein; MMRM, mixed model repeated measures; MRI, magnetic resonance imaging; PBO, placebo; SPARCC, Spondyloarthritis Research Consortium of Canada; UPA, upadacitinibAcknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and participated in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Medical writing support was provided by Laura Chalmers, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Filip van den Bosch Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Janssen, and UCB, Denis Poddubnyy Speakers bureau: AbbVie, Celgene, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Celgene, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Jayne Stigler Employee of: AbbVie employee and may own stock or options, Andrew Ostor Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB, Salvatore D’Angelo Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Victoria Navarro-Compán Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, In-Ho Song Employee of: AbbVie employee and may own stock or options, Tianming Gao Employee of: AbbVie employee and may own stock or options, Fabiana Ganz Employee of: AbbVie employee and may own stock or options, Lianne S. Gensler Consultant of: AbbVie, Eli Lilly, Gilead, GSK, Novartis, Pfizer, and UCB, Grant/research support from: Pfizer and UCB
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Movahedi, M., D. Choquette, L. Coupal, A. Cesta, X. Li, E. Keystone, and C. Bombardier. "POS0448 DISCONTINUATION RATE OF TOFACITINIB AS MONOTHERAPY IS SIMILAR COMPARED TO COMBINATION THERAPY WITH METHOTREXATE IN RHEUMATOID ARTHRITIS PATIENTS: POOLED DATA FROM TWO RHEUMATOID ARTHRITIS REGISTRIES IN CANADA." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 454.2–454. http://dx.doi.org/10.1136/annrheumdis-2021-eular.920.
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Background:Tofacitinib (TOFA) is an oral, small molecule drug used for rheumatoid arthritis (RA) treatment and is prescribed alone or with methotrexate (MTX). We previously reported the similarity in retention between TOFA monotherapy and TOFA with MTX using data from two different registries separately; the Ontario Best Practices Research Initiative (OBRI) and the Quebec registry RHUMADATA.Objectives:To increase the study power, we propose to evaluate the discontinuation rate (due to any reason) of TOFA with and without MTX, using pooled data from these two registries.Methods:RA patients enrolled in the OBRI and RHUMADATA initiating their TOFA between 1st June 2014 (TOFA approval date in Canada) and 31st Dec 2019 were included. Concurrent MTX use was defined as MTX use for more than 75% of the time while using TOFA. Multiple imputation (Imputation Chained Equation method, N=20) was used to deal with missing data for covariates at treatment initiation.Time to discontinuation was assessed using Cox regression models. To deal with confounding by indication, we estimated propensity scores for selected covariates with an absolute standard difference greater than 0.1. We then adjusted Cox regression models for propensity quantile to compare the discontinuation of TOFA with MTX versus TOFA without MTX.Results:A total of 493 patients were included. Of those, 244 (49.5%) and 249 (51.5%) were treated with MTX and without MTX, respectively. Compared to TOFA monotherapy, the TOFA with MTX group had a significantly lower mean HAQ-DI, fatigue score, and the number of prior biologic use at the time of TOFA initiation. A lower proportion of positive ACPA (59% vs. 66%), prevalence of hypertension (31% vs 37%), and concomitant use of Leflunomide (11% vs. 23%) were also observed for patients using TOFA with MTX.Over a mean follow-up of 19.0 months, discontinuation was reported in 182 (36.9%) of all TOFA patients. After adjusting for propensity score quantile across 20 imputed datasets, there was no significant difference in discontinuation between treatment groups (adjusted HRs: 1.12, 95% CI: 0.83-1.51; p=0.49).Conclusion:In this pooled real-world data study, we found that in patients with RA, the retention of TOFA is similar if it is used as monotherapy or in combination with MTX.Disclosure of Interests:Movahedi: None declared, Denis Choquette Grant/research support from: Rhumadata is supported by unrestricted grants from Abbvie Canada, Amgen Canada, Eli Lilly Canada, Novartis Canada, Pfizer Canada, Sandoz Canada and Sanofi Canada., Louis Coupal: None declared, Angela Cesta: None declared, Xiuying Li: None declared, Edward Keystone Grant/research support from: Amgen, Merck, Pfizer Pharmaceuticals, PuraPharm. Speaker Honoraria Agreements: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis. Consulting Agreements/Advisory Board Membership: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis, Claire Bombardier Grant/research support from: OBRI was funded by peer reviewed grants from CIHR (Canadian Institute for Health Research), Ontario Ministry of Health and Long-Term Care (MOHLTC), Canadian Arthritis Network (CAN) and unrestricted grants from: Abbvie, Amgen, Aurora, Bristol-Meyers Squibb, Celgene, Hospira, Janssen, Lilly, Medexus, Merck, Novartis, Pfizer, Roche, Sanofi, & UCB.Acknowledgment: :Dr. Bombardier held a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care and a Pfizer Research Chair in Rheumatology
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Coates, L. C., E. Soriano, N. Corp, H. Bertheussen, K. Callis-Duffin, C. Barbosa Campanholo, J. Chau, et al. "OP0229 THE GROUP FOR RESEARCH AND ASSESSMENT OF PSORIASIS AND PSORIATIC ARTHRITIS (GRAPPA) TREATMENT RECOMMENDATIONS 2021." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 139–40. http://dx.doi.org/10.1136/annrheumdis-2021-eular.4091.
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Background:Since the 2015 GRAPPA treatment recommendations were published, therapeutic options and management strategies for psoriatic arthritis (PsA) have advanced considerably.Objectives:The goal of the GRAPPA recommendations update is to develop high quality, evidence-based recommendations for the treatment of PsA, including related conditions and comorbidities.Methods:GRAPPA rheumatologists, dermatologists and patient research partners (PRPs) updated overarching principles for the management of adults with PsA by consensus. Principles considering use of biosimilars and tapering/discontinuing of therapy were added to this update. Systematic literature searches based on data publicly available from three databases (MEDLINE, EMBASE, and Cochrane CENTRAL) were conducted from the end of the previous recommendations’ searches through August 2020. Additional abstract searches were performed for conference presentations in 2017-2020. Searches covered PsA treatments (peripheral arthritis, axial arthritis, enthesitis, dactylitis, skin, and nail disease). Additional searches were performed for related conditions (uveitis and IBD) and comorbidities evaluating their impact on safety and treatment outcomes. Individual groups assessed the risk of bias and applied the GRADE system to generate strong or conditional recommendations for therapies within the domain groups and for the management of comorbidities and related conditions. These recommendations were then incorporated into an overall treatment schema.Results:Updated, evidence-based treatment recommendations are shown (Table 1). Since 2015, many new medications have been incorporated. Additional results for older medications, such as methotrexate, have been published across PsA domains. Based on the evidence, the treatment recommendations developed by individual groups were incorporated into the overall schema including principles for management of arthritis, spondylitis, enthesitis, dactylitis, skin, and nail disease in PsA, and associated conditions (Figure 1). Choice of therapy for an individual should ideally address all of the domains that impact on that patient, supporting shared decision making with the patient involved. Additional consideration in the recommendations was given to key associated conditions and comorbidities as these often impact on therapy choice.Conclusion:These GRAPPA treatment recommendations provide up to date, evidence-based guidance to providers who manage and treat adult patients with PsA. These recommendations are based on domain-based strategy for PsA and supplemented by overarching principles developed by consensus of GRAPPA members.IndicationStrongForConditional ForConditionalAgainstStrongAgainstInsufficient evidencePeripheral Arthritis DMARD NaïvecsDMARDs, TNFi, PDE4i, IL-12/23i, IL-17i, IL-23i, JAKiNSAIDs, oral CS, IA CS,IL-6i,Peripheral Arthritis DMARD IRTNFi, IL-12/23i, IL-17i, IL-23i, JAKiPDE4i, other csDMARD, NSAIDs, oral CS, IA CS,IL-6i,Peripheral ArthritisbDMARD IRTNFi, IL-17i, IL-23i, JAKi,NSAIDs, oral CS, IA CS, IL-12/23i, PDE4i, CTLA-4-IgIL-6i,Axial arthritis, Biologic NaïveNSAIDs, Physiotherapy, simple analgesia, TNFi, IL-17i, JAKiCS SIJ injections, bisphosphonatescsDMARDs, IL-6i,IL-12/23i, IL-23iAxial PsA, Biologic IRNSAIDs, Physiotherapy, simple analgesia, TNFi, IL-17i, JAKi csDMARDs, IL-6i,IL-12/23i, IL-23iEnthesitisTNFi, IL-12/23i, IL-17i, PDE4i, IL-23i, JAKiNSAIDs, physiotherapy, CS injections, MTXIL-6i,Other csDMARDsDactylitisTNFi IL-12/23i, IL-17i, IL-23i, JAKi, PDE4iNSAIDs, CS injections, MTXOther csDMARDsPsoriasisTopicals, phototherapy, csDMARDs, TNFi, IL-12/23i, IL-17i, IL-23i, PDE4i, JAKi AcitretinNail psoriasisTNFi, IL12/23i, IL17i, IL23i, PDE4iTopical CS, tacrolimus and calcipotriol combination or individual therapies, Pulsed dye laser, csDMARDs, acitretin, JAKiTopical Cyclosporine / Tazarotene, Fumarate, Fumaric Acid Esters, UVA and UVB Phototherapy, AlitretinoinIBDTNFi (not ETN), IL-12/23i, JAKiIL-17iUveitisTNFi (not ETN)Disclosure of Interests:Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, Eli Lilly, Janssen, Medac, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Pfizer, and Novartis, Enrique Soriano Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb,GSK, Genzyme, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb,GSK, Genzyme, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Grant/research support from: AbbVie, Janssen, Novartis Pharma, Pfizer, Roche, and UCB, Nadia Corp: None declared, Heidi Bertheussen Consultant of: Pfizer, Kristina Callis-Duffin Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Lilly, Janssen, Novartis, Pfizer, Sienna Biopharmaceuticals, Stiefel Laboratories, UCB, Ortho Dermatologics, Inc, Regeneron Pharmaceuticals, Inc., Anaptys Bio, Boehringer Ingelheim., Cristiano Barbosa Campanholo Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Jeffrey Chau: None declared, Lihi Eder Consultant of: Abbvie, UCB, Janssen, Eli Lily, Pfizer, Novartis, Grant/research support from: Abbvie, UCB, Janssen, Eli Lily, Pfizer, Novartis, Daniel Fernandez Consultant of: Abbvie, UCB, Roche, Janssen, Pfizer, Amgen and Brystol, Grant/research support from: Abbvie, UCB, Roche, Janssen, Pfizer, Amgen and Brystol, Oliver FitzGerald Speakers bureau: AbbVie, Janssen and Pfizer Inc, Consultant of: BMS, Celgene, Eli Lilly, Janssen and Pfizer Inc, Grant/research support from: AbbVie, BMS, Eli Lilly, Novartis and Pfizer Inc, Amit Garg Consultant of: Abbvie, Amgen, Asana Biosciences, Bristol Myers Squibb, Boehringer Ingelheim, Incyte, InflaRx, Janssen, Pfizer, UCB, Viela Biosciences, Grant/research support from: Abbvie, Dafna D Gladman Consultant of: Abbvie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Jansen, Novartis, Pfizer and UCB, Grant/research support from: Abbvie, Amgen, Eli Lilly, Jansen, Novartis, Pfizer and UCB, Niti Goel: None declared, Suzanne Grieb: None declared, Philip Helliwell Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: Eli Lilly, M Elaine Husni Consultant of: Abbvie, Amgen, Janssen, Novartis, Lilly, UCB, Regeneron, and Pfizer, Deepak Jadon Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Healthcare Celltrion, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, UCB, Arnon Katz: None declared, Dhruvkumar Laheru: None declared, John Latella: None declared, Ying Ying Leung Speakers bureau: Novartis, AbbVie, Eli Lilly, Janssen, Consultant of: Pfizer and Boehringer Ingelheim, Grant/research support from: Pfizer and conference support from AbbVie, Christine Lindsay Shareholder of: Amgen, Employee of: Aurinia pharmaceuticals, Ennio Lubrano Speakers bureau: Alfa-Sigma, Abbvie, Galapagos, Janssen Cilag, Lilly., Consultant of: Alfa-Sigma, Abbvie, Galapagos, Janssen Cilag, Lilly., Luis Mazzuoccolo Speakers bureau: Abbvie, Amgen, Novartis, Elli Lilly, Jansen, Consultant of: Abbvie, Amgen, Novartis, Elli Lilly, Jansen, Roland McDonald: None declared, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN and UCB, Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead Sciences, Janssen, Novartis, Pfizer, SUN and UCB, Denis O’Sullivan: None declared, Alexis Ogdie Consultant of: AbbVie, Amgen, BMS, Celgene, Corrona, Gilead, Janssen, Lilly, Novartis, and Pfizer, Grant/research support from: Novartis and Pfizer and Amgen, Wendy Olsder: None declared, Lori Schick: None declared, Ingrid Steinkoenig: None declared, Maarten de Wit Consultant of: AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Danielle van der Windt: None declared, Arthur Kavanaugh Speakers bureau: AbbVie, Amgen, BMS, Eli Lilly, Gilead Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, BMS, Eli Lilly, Gilead Janssen, Novartis, Pfizer, UCB
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Kedra, J., R. Seror, P. Dieudé, A. Constantin, E. Toussirot, E. Kfoury, C. Masson, et al. "OP0125 LYMPHOMAS COMPLICATING RHEUMATOID ARTHRITIS: RESULTS OF A FRENCH MULTI-CENTRE CASE-CONTROL STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 82–83. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3930.
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Background:Rheumatoid arthritis (RA) is associated with an increased risk of non-Hodgkin B-cell lymphoma (B-cell NHL).Objectives:1)To study the characteristics of B-cell NHL complicating RA2)To identify the factors associated with their occurrence.Methods:A multi-centre case-control study was performed in France. Cases were patients with RA fulfilling the ACR-EULAR 2010 criteria, who developed a B-cell NHL after the diagnosis of RA. Cases were reported following a call for observations by the “Club Rhumatismes et Inflammation” network, registries from the French society of Rheumatology (AIR, ORA and REGATE) and the ESPOIR cohort. For each case, 2 control patients were drawn at random from patients in the ESPOIR cohort with RA fulfilling the ACR-EULAR 2010 criteria; cases and controls were matched on age (age at lymphoma diagnosis for cases and age at the 10-year ESPOIR visit for controls). Patients with associated Sjögren’s syndrome were excluded. Cases and controls characteristics were compared for parameters associated with the occurrence of lymphoma.Results:A total of 54 cases were included and matched to 108 controls. Lymphomas were mostly diffuse large B-cell lymphomas (n=26, 48.2%)(Figure 1). EBV positivity was found in 4 cases among 27 tested (14.8%). Cases had a mean age of 63.5 years (SD=10.9), and had a mean RA duration of 12.4 years (SD=10.5) at the time of diagnosis of lymphoma; there was no significant difference with controls (p=0.47 and p=0.40 respectively). The mean duration of follow-up after the diagnosis of lymphoma was 5.2 years (SD=5.8). In univariate analysis, factors associated with occurrence of B-cell NHL were: male gender (OR=3.3, 95%CI: 1.7-6.7), positive ACPA (OR=5.1, 95%CI: 2.0-15.7), positive Rheumatoid Factor (RF) (OR=3.9, 95%CI=1.6-12.2), erosions on X-rays (OR=15.4, 95%CI: 6.9-37.7) and DAS28 (OR=2.0, 95%CI: 1.5-2.7). Methotrexate, TNF-blockers and the number of previous biologics were not associated with the occurrence of B-cell NHL. Hydroxychloroquine and sulfasalazine were more frequent in cases versus control, which could be linked to a date bias. Erosions and DAS28 remained significant in multivariate analysis(Table 1).Conclusion:This study revealed an association between markers of activity (DAS28), severity (erosions) and autoimmune B-cell activation (RF and ACPA) and the risk of B-cell NHL in patients with RA, supporting the continuum between autoimmunity and lymphomagenesis in RA.Figure 1.lymphomas histologyTable 1.association between RA characteristics and B-cell NHL in univariate and multivariate analysisVariablesCases (N=54)Controls (N=108)Univariate analysisMultivariate analysisOR (95%CI)p-valueOR (95%CI)p-valueMale gender, N (%)27 (50.0)25 (23.2)3.3(1.7-6.7)0.00062.2(0.8-6.1)0.13Positive ACPA, N (%)49 (90.7)71 (65.7)5.1(2.0-15.7)0.0006--Positive RF, N (%)49 (90.7)77 (71.3)3.9(1.6-12.2)0.005--Positive RF or ACPA, N (%)49 (90.7)80 (74.1)3.4(1.3-10.6)0.012.9(0.7-15.0)0.16Erosions on X-rays, N (%)44 (81.5)26 (24.1)15.4(6.9-37.7)< 0.00019.8(3.8-28.2)< 0.0001DAS28 at B-cell NHL diagnosis/at the 10th year visit*, mean(SD)4.1 (1.6)2.6 (1.4)2.0(1.5-2.7)< 0.00011.9(1.3-2.8)0.0007*B-cell NHL diagnosis for cases, 10thyear visit for controlsDisclosure of Interests:Joanna KEDRA: None declared, Raphaèle Seror Consultant of: BMS UCB Pfizer Roche, Philippe Dieudé: None declared, Arnaud Constantin: None declared, ERIC TOUSSIROT: None declared, Elias Kfoury: None declared, Charles Masson: None declared, Divi Cornec: None declared, Jean-Jacques Dubost: None declared, Laurent Marguerie: None declared, Sebastien Ottaviani: None declared, Franck Grados: None declared, Rakiba Belkhir: None declared, olivier fain: None declared, Philippe Goupille Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Christelle Sordet: None declared, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, Peggy Philippe: None declared, Muriel PIPERNO: None declared, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, Olivier Lambotte Consultant of: BMS France, MSD, Astra Zeneca, Incyte, Christophe Richez Consultant of: Abbvie, Amgen, Mylan, Pfizer, Sandoz and UCB., Jérémie SELLAM: None declared, Thomas Sene: None declared, Guillaume Denis: None declared, Thierry Lequerre: None declared, Xavier Mariette Consultant of: BMS, Gilead, Medimmune, Novartis, Pfizer, Servier, UCB, Gaetane Nocturne: None declared
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Maksymowych, W. P., H. Marzo-Ortega, M. Ǿstergaard, L. S. Gensler, J. Ermann, A. Deodhar, D. Poddubnyy, et al. "THU0395 EFFICACY OF IXEKIZUMAB ON DISEASE ACTIVITY AND QUALITY OF LIFE IN PATIENTS WITH ACTIVE NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND OBJECTIVE SIGNS OF INFLAMMATION, STRATIFIED BY BASELINE CRP/SACROILIAC JOINT MRI STATUS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 432–33. http://dx.doi.org/10.1136/annrheumdis-2020-eular.2027.
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Background:Ixekizumab (IXE), a high-affinity anti-interleukin-17A monoclonal antibody, is effective in patients (pts) with active non-radiographic axial spondyloarthritis (nr-axSpA), who had elevated C-reactive protein (CRP) and/or active sacroiliitis on magnetic resonance imaging (MRI).1Objectives:To determine if disease activity and patient-reported outcomes at Week 16 were similar between groups after stratifying pts by CRP/sacroiliac joint (SIJ) MRI status at baseline.Methods:COAST-X (NCT02757352) included pts with active nr-axSpA and objective signs of inflammation, i.e. presence of sacroiliitis on MRI (Assessment of Spondyloarthritis International Society [ASAS]/ Outcome Measures in Rheumatology criteria) or elevation of serum CRP (>5.0 mg/L). Pts were randomized 1:1:1 to receive subcutaneous 80 mg IXE every 4 weeks (Q4W) or Q2W, or placebo (PBO). Depending on the baseline values of CRP and MRI SIJ (Spondyloarthritis Research Consortium of Canada [SPARCC] score), pts in the intent-to-treat population (N=239) were divided into 3 subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2). Logistic regression analysis with treatment, subgroup, and treatment-by-subgroup interaction was used to detect treatment group differences in ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1 (low disease activity), and Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) responses at Week 16. Analysis of covariance model with baseline value, treatment, subgroup, and treatment-by-subgroup interaction was used to detect the treatment group difference in change from baseline in Short Form-36 physical component score (SF-36 PCS).Results:The proportion of pts achieving ASAS40 (primary endpoint), ASDAS <2.1, and BASDAI50 (secondary endpoints) was higher in IXE treatment groups compared to PBO at Week 16 (Figure 1). The response rates in IXE-treated subjects were higher in all subgroups (CRP >5 and MRI ≥2; CRP ≤5 and MRI ≥2; CRP >5 and MRI <2) without consistent differences in efficacy between the subgroups. Similarly, pts in the IXE groups showed improvement in SF-36 PCS scores (secondary endpoint) versus pts on PBO at Week 16 (Figure 2).Conclusion:Pts with active nr-axSpA and objective signs of inflammation at baseline who were treated with IXE showed an overall improvement in the signs and symptoms of the disease. The efficacy was not different between pts with both elevated CRP and active sacroiliitis on MRI and pts with either elevated CRP or active sacroiliitis on MRI.References:[1]Deodhar A, et al.Lancet.2020.Disclosure of Interests:Walter P Maksymowych Grant/research support from: Received research and/or educational grants from Abbvie, Novartis, Pfizer, UCB, Consultant of: WPM is Chief Medical Officer of CARE Arthritis Limited, has received consultant/participated in advisory boards for Abbvie, Boehringer, Celgene, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Received speaker fees from Abbvie, Janssen, Novartis, Pfizer, UCB., Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Lianne S. Gensler Grant/research support from: Pfizer, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, GSK, Novartis, UCB, Joerg Ermann Grant/research support from: Boehringer-Ingelheim, Pfizer, Consultant of: Abbvie, Eli Lilly, Janssen, Novartis,Pfizer, Takeda, UCB, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gabriel Doridot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Martin Rudwaleit Consultant of: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma
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Richebé, P., S. Godot, G. Coiffier, P. Guggenbuhl, D. Mulleman, M. Couderc, E. Dernis, et al. "FRI0449 MANAGEMENT AND OUTCOME OF SEPTIC ARTHRITIS OF NATIVE JOINT: A NATIONWIDE SURVEY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 821.3–822. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5817.
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Background:Objectives:To describe current management and outcome of septic arthritis on native joint in French rheumatology departments.Methods:Retrospective, nation-wide multicentric study. 127 French rheumatology departments were contacted to report 10 successive cases of septic arthritis on native joint that occurred between the 01/01/16 to 31/12/17 (excluding mycobacteria). Characteristics, diagnosis procedure, therapeutic management and outcome were recorded.Results:52 centers included 363 patients (mean age 64± 18.7 years, mean Charlson comorbidity index 4±3). 28.3% patients had a preexisting arthropathy on affected joint. Monoarthritis was observed in 89.6% patients, knee was the most frequent site (38.9%). The most frequent pathogens wereStaphylococcus sp(50.7%) andStreptococcus sp.(23.3%). Bacteremia was found in 156 (45.1%) patients and endocarditis in only 12 (3.0%). Management was heterogeneous. All patients received antibiotics for a mean duration of 46.7±22 days (including intravenous route: 17.3±15.4 d). An initial monotherapy was administered in 42.3% of patients. Surgical procedure (mostly lavage 70.6%) was performed in 171 (48.3%), joint immobilization in 128 (35.3%) (median duration of 21.7±14.1 days). 94 (29.2%) patients have had serious complications including 29 (9.5%) death. Factors associated with death are reported in the table.Conclusion:This study shows that management of septic arthritis is very heterogenous with a still high rate of morbidity and mortality. We identified age, comorbidities, bacteremia and recent antibiotherapy were associated with mortality. Of note, duration of antibiotics was not. Thus, new guidelines are needed in order to facilitate septic arthritis management.Table:FactorsSurvivor(N=276)Dead(N=29)Univariate analysispAdjusted Odds ratio (95%IC)Multivariate analysispAge65 (16-97)82 (32-98)<0,0011,07 (1,03-1,12)< 0.001Charlson’s index1 (0-12)2 (0-9)0,00011,3 (1,05-1,63)0,018Delay before antibiotic initiation8,5 (0-310)5 (0-75)0,04840,99 (0,96-1,02)0,562Corticosteroid in the previous 3 months13,9%33,3%0,01842,56 (0,75-8,74)0,133Bacteriemia42,4%71,4%0,00615,07 (1,4-18,370,013Antibiotics in the previous 3 months26,6%56,6%0,00566,7 (2,04-22,01)0,002Disclosure of Interests:Pauline Richebé: None declared, Sophie Godot: None declared, Guillaume Coiffier: None declared, Pascal GUGGENBUHL: None declared, Denis Mulleman: None declared, Marion Couderc: None declared, Emmanuelle Dernis Speakers bureau: Lilly, Novartis, Valentine Deprez: None declared, Carine Salliot: None declared, Saik Urien: None declared, Rachel Brault: None declared, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Emmanuel Hoppe: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Christian Roux: None declared, Sebastien Ottaviani: None declared, Maxime Breban: None declared, Marie Beaufrere: None declared, Alexia Michaut: None declared, Loic Pauvele: None declared, Christelle Darrieutort: None declared, Daniel Wendling: None declared, Pascal COQUERELLE: None declared, Géraldine Bart: None declared, Elisabeth Gervais: None declared, Vincent Goeb: None declared, Marc Ardizzone: None declared, Edouard Pertuiset: None declared, Sophie Derolez: None declared, Jean Marc Ziza: None declared, René-Marc Flipo Consultant of: Johnson and Johnson, MSD France, Novartis, Sanofi, Speakers bureau: Johnson and Johnson, MSD France, Novartis, Sanofi, Raphaèle Seror Consultant of: BMS UCB Pfizer Roche
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Garrido-Cumbrera, M., D. Poddubnyy, C. Bundy, L. Christen, R. Mahapatra, S. Makri, C. J. Delgado-Domínguez, S. Sanz-Gómez, P. Plazuelo-Ramos, and V. Navarro-Compán. "POS0244 PATIENT JOURNEY WITH AXIAL SPONDYLOARTHRITIS: CRITICAL ISSUES FROM THE PATIENT PERSPECTIVE. RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 343.2–344. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2426.
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Background:The journey of axial spondyloarthritis (axSpA) for most patients is slow and arduous.Objectives:The goal of this analysis is to describe the journey to diagnosis and further management in axSpA patients.Methods:2,846 unselected patients participated in EMAS, a cross-sectional study (2017-2018) across 13 European countries. Descriptive analysis of sociodemographic factors, insurance scheme, diagnostic journey and post diagnosis healthcare utilization was performed. Mann-Whitey test was used to analyse possible differences between BASDAI (>4 v ≤4) and the number of visits to healthcare professionals and follow-up tests undertaken.Results:Mean age was 43.9 years, 61.3% were female, 48.1% university educated, 67.9% married, 53.9% employed and 81.7% had public health insurance. Mean age at symptoms onset was 26.6 (11.1), while mean age at diagnosis was 33.7 (11.5) and mean diagnostic delay was 7.4 years. Over 50% had a diagnostic delay of ≥4 years. Prior to receiving a diagnosis, patients visited on average 2.6 specialists. The most commonly performed diagnostic tests were x-rays (72.3%), HLA B27 tests (65.4%) and MRIs (64.3%). 78.4% were diagnosed by a rheumatologist while 14.9% received their diagnosis by a GP. Patients who experienced a diagnostic delay of more than a year (n= 2,208) undertook a considerable number of visits to specialists and medical tests in the year prior to participating in EMAS, which increased with disease activity. Patients with active disease (BASDAI >4) reported a higher number of visits to rheumatologists (3.7±3.5 vs 2.9±2.6), general practitioners (6.6±10.0 vs 3.5±4.1), physiotherapists (19.3±25.0 vs 11.7±17.0), and psychologists/psychiatrists (3.4±10.7 vs 1.9±7.7). Patients with active disease also undertook more x-rays (1.8±2.8 vs. 1.3±1.9), MRI scans (0.9±1.2 vs. 0.6±1.1), and blood tests (4.7±4.4 vs 3.6±3.2). However, one in five patients visited the rheumatologist only once in the year prior to EMAS (21.1%).Conclusion:Diagnostic delay continues to be a key challenge in the axSpA patient journey, with patients waiting an average of 7.4 years and visiting multiple doctors prior to diagnosis. Once diagnosed, disease management presents a further challenge, as patients with higher disease activity reported more healthcare professional visits as well as medical tests. Safeguarding health and controlling healthcare utilization requires effective disease management, greater education for non-specialists, rapid referral routes for diagnosis and collaborative care between specialists and non-specialists.Figure 1.axSpA Patient journey according to EMASAcknowledgements:This study was supported by Novartis Pharma AG. The authors would like to thank all participants who participated in this study.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Denis Poddubnyy Consultant of: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Abbvie, MSD, Novartis and Pfizer, Christine Bundy Consultant of: Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer, Laura Christen Employee of: Novartis Pharma AG, Raj Mahapatra: None declared, Souzi Makri: None declared, Carlos Jesús Delgado-Domínguez: None declared, Sergio Sanz-Gómez: None declared, Pedro Plazuelo-Ramos: None declared, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB
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Movahedi, M., D. Choquette, L. Coupal, A. Cesta, X. LI, E. Keystone, and C. Bombardier. "OP0179 DISCONTINUATION RATE OF TOFACITINIB IS SIMILAR WHEN COMPARED TO TNF INHIBITORS IN RHEUMATOID ARTHRITIS PATIENTS: POOLED DATA FROM TWO RHEUMATOID ARTHRITIS REGISTRIES IN CANADA." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 107–8. http://dx.doi.org/10.1136/annrheumdis-2021-eular.912.
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Background:Tofacitinib (TOFA) is an oral, small molecule drug used for rheumatoid arthritis (RA) treatment as the first or an alternative option to biologic disease- modifying antirheumatic drugs (bDMARDs), including tumor necrosis factor inhibitors (TNFi). The similarity in retention of TNFi and TOFA was previously reported separately by the Ontario Best Practices Research Initiative (OBRI) and the Quebec cohort RHUMADATA®.Objectives:To increase the study power, we propose to evaluate the discontinuation rate (due to any reason) of TNFi compared to TOFA, using pooled data from both these registries.Methods:RA patients enrolled in the OBRI and RHUMADATA initiating their TOFA or TNFi between 1st June 2014 (TOFA approval date in Canada) and 31st Dec 2019 were included. Time to discontinuation was assessed using adjusted Kaplan-Meier (KM) survival and Cox regression models. To deal with confounding by indication, we estimated propensity scores for covariates with a standard difference greater than 0.1. Models were then adjusted using stratification and inverse probability of treatment weight (IPTW) methods. Multiple imputation (Imputation by Chained Equation method, N=20) was used to deal with missing data for covariates at treatment initiation.Results:A total of 1318 patients initiated TNFi (n=825) or TOFA (n=493) with mean (SD) disease duration of 8.9 (9.3) and 13.0 (10.1) years, respectively. In the TNFi group, 78.8% were female and mean age (SD) at treatment initiation was 57.6 (12.6) years. In the TOFA group, 84.6% were female and mean (SD) age at treatment initiation was 59.5 (11.5) years. The TNFi group was less likely to have prior biologic use (33.9%) than the TOFA group (66.9%). At treatment initiation, the mean (SD) CDAI was significantly (p<0.05) lower in the TNFi group [20.0 (11.7)] compared to the TOFA group [22.1(12.4)]. Physical function measured by HAQ-DI was also significantly lower (p<0.05) in the TNFi compared to the TOFA group (1.2 vs.1.3).Over a mean follow-up of 23.2 months, discontinuation was reported in 309 (37.5%) and 182 (36.9%) of all TNFi and TOFA patients, respectively. After adjusting for propensity score deciles across 20 imputed datasets, there was no significant difference in discontinuation between treatment groups (adjusted HRs: 0.96, 95% CI: 0.78-1.18; p=0.69). The results were similar for two propensity adjustment methods. Figure 1 shows IPTW adjusted KM survival curves comparing discontinuation rates in patients treated with TNFi and TOFA.Figure 1.Note: Propensity Score Weighted (IPTW) Survival Curves was performed using one imputed datasetConclusion:In this pooled real -world data study, we found that TNFi and TOFA retention is similar in patients with RA. In the next step we will analysis the data for specific reasons of dicontinutaion. We will also repeat analysis comparing discontinuation in the first users versus those after one or more biologic failure.Disclosure of Interests:Mohammad Movahedi: None declared, Denis Choquette Grant/research support from: Rhumadata® is supported by unrestricted grants from Abbvie Canada, Amgen Canada, Eli Lilly Canada, Novartis Canada, Pfizer Canada, Sandoz Canada and Sanofi Canada., Louis Coupal: None declared, Angela Cesta: None declared, Xiuying Li: None declared, Edward Keystone Grant/research support from: Amgen, Merck, Pfizer Pharmaceuticals, PuraPharm. Speaker Honoraria Agreements: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis. Consulting Agreements/Advisory Board Membership: AbbVie, Amgen, Bristol-Myers Squibb Company, Celltrion, Myriad Autoimmune, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, Sanofi-Genzyme, Samsung Bioepsis, Claire Bombardier Grant/research support from: OBRI was funded by peer reviewed grants from CIHR (Canadian Institute for Health Research), Ontario Ministry of Health and Long-Term Care (MOHLTC), Canadian Arthritis Network (CAN) and unrestricted grants from: Abbvie, Amgen, Aurora, Bristol-Meyers Squibb, Celgene, Hospira, Janssen, Lilly, Medexus, Merck, Novartis, Pfizer, Roche, Sanofi, & UCB.Dr. Bombardier held a Canada Research Chair in Knowledge Transfer for Musculoskeletal Care and a Pfizer Research Chair in Rheumatology
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Brettingham, Madeleine. "Roche denies claims it sacked employee for “whistle blowing”." BMJ 332, no. 7551 (May 18, 2006): 1175.4. http://dx.doi.org/10.1136/bmj.332.7551.1175-c.
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Garrido-Cumbrera, M., V. Navarro-Compán, C. Bundy, R. Mahapatra, S. Makri, J. Correa-Fernández, L. Christen, C. J. Delgado-Domínguez, and D. Poddubnyy. "OP0278 IDENTIFICATION OF PARAMETERS ASSOCIATED WITH A DIAGNOSTIC DELAY IN AXIAL SPONDYLOARTHRITIS: RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 173–74. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4221.
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Background:Early diagnosis of Axial Spondyloarthritis (axSpA) is crucial for timely access to specialist care and effective treatment.Objectives:To assess the current diagnostic delay in axSpA and identify the parameters associated with increased diagnostic delay in a European sample.Methods:Data from unselected patients participating in the European Map of Axial Spondyloarthritis (EMAS) study through an online survey (2017- 2018) across 13 countries were analysed. Mean differences in diagnostic delay were analysed using Mann-Whitney and Kruskal-Wallis tests, among sociodemographic and disease-related factors. A multivariate linear regression analysis was carried out to identify the relative weight of the associated parameters in determining diagnostic delay.Results:2,846 patients participated in EMAS. Mean age was 43.9 years, 61.3% were female, 48.1% had a university degree, and 53.9% were employed. Of the 2846 participants, 2652 provided information for calculating diagnostic delay. Mean age at symptom onset was 26.6 ± 11.1, mean age at diagnosis was 33.7 ± 11.5, and mean diagnostic delay was 7.4 ± 8.4 (Fig. 1). The following variables were associated with longer diagnostic delay in the bivariate analysis: older age, female gender, being diagnosed by a rheumatologist (Table 1). In the multivariate regression analysis younger age at symptom onset, number of HCPs seen before were associated with diagnostic delay (Table 2).Table 1.Associations between sociodemographic and disease-related variables and diagnostic delay (N: 2,652)VariableDiagnostic Delay (years)Mean ± SDP-valueAge categories18-344.4 ± 5.5<0.00135-517.9 ± 8.252-689.5 ± 10.2>687.3 ± 9.7GenderMale6.1 ± 7.4<0.001Female8.2 ± 8.9Education levelNo school completed8.0 ± 10.70.397Primary school7.6 ± 8.9High school7.6 ± 8.4University7.3 ± 8.3OccupationManual worker6.7 ± 8.30.163Non-manual worker7.3 ± 8.4Diagnosed by rheumatologistYes7.9 ± 8.7<0.001No5.7 ± 7.3HLA-B27Positive8.3 ± 8.30.775Negative8.7 ± 9.0Uveitis (ever)Yes8.0 ± 8.30.098No7.6 ± 8.4IBD (ever)Yes7.7 ± 8.70.944No7.5 ± 8.5Table 2.Regression analysis between sociodemographic and clinical variables in relation to diagnostic delayVariableUnivariable linear regressionMultivariable stepwise linear regressionB95% CIB95% CIAge at symptoms onset-0.289-0.316, -0.262-0.321-0.390, -0.253Female gender2.0991.442, 2.755NANAEmployed, Manual worker-0.604-1.953, 0.746NANAEducational status, University-0.343-0.986, 0.299NANADiagnosed by rheumatologist, Yes2.1171.321, 2.913NANANumber of HCPs seen before diagnosis1.7231.486, 1.9601.2580.739, 1.776HLA-B27, Positive-0.471-1.347, 0.404NANAUveitis (ever), Yes0.463-0.392, 1.319NANAIBD (ever), Yes0.123-0.971, 1.217NANAFigure 1.Average years of diagnostic delay across EMAS countries (N: 2,652)Conclusion:In this large sample of axSpA patients from 13 different European countries, the average diagnostic delay was more than seven years. The fact that one of the most strongly associated parameters to diagnostic delay was number of HCPs seen before diagnosis suggests the need for urgent action to reduce incorrect referrals to shorten the patient journey to diagnosis across Europe.Acknowledgments:Funded by Novartis Pharma AGDisclosure of Interests:Marco Garrido-Cumbrera: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Christine Bundy Grant/research support from: Has received unrelated honoraria from Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer., Raj Mahapatra: None declared, Souzi Makri: None declared, José Correa-Fernández: None declared, Laura Christen: None declared, Carlos Jesús Delgado-Domínguez: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Hudon, Raymond. "Roch DENIS (dir.), Québec : dix ans de crise constitutionnelle." Recherches sociographiques 32, no. 3 (1991): 468. http://dx.doi.org/10.7202/056649ar.
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Garrido-Cumbrera, M., C. Bundy, D. Poddubnyy, S. Makri, R. Mahapatra, S. Sanz-Gómez, L. Christen, C. J. Delgado-Domínguez, and V. Navarro-Compán. "OP0081 THE IMPACT OF AXIAL SPONDYLOARTHRITIS ON PATIENTS’ SEXUAL LIFE: RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 54.2–55. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4277.
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Background:Axial Spondyloarthritis (axSpA) involves a great degree of functional limitation in daily activities and psychological health, which can impact patients’ sexual life.Objectives:To study the determinants of reduced frequency of sexual activity and intimacy since disease onset in axSpA patients.Methods:Data from 2,846 unselected patients of the European Map of Axial Spondyloarthritis (EMAS) through an online survey (2017-2018) across 13 countries were analysed. The impact of axSpA on patients’ sexual life was evaluated by a question assessing changes in the frequency of intimate relations since the onset of axSpA on a 5 point Likert scale. Impact of axSpA on the spousal relationship since disease onset was also assessed using 5 point Likert scale. Other lifestyle variables included smoking and physical activity and burden of disease [BASDAI (0-10), spinal stiffness (3-12), functional limitation in intimate relations (0-2), and psychological distress (GHQ-12)]. Regression analysis were carried out to determine the relative weight of the assessed variables.Results:EMAS total sample mean age was 43.9 years, 61.3% were female, 48.1% had a university degree, and 67.9% were married. Out of the 2,515 participants that reported on the frequency of intimate relations since disease onset, 56.4% declared that it was less or much less than before; 74.1% declared high or medium limitation in intimate relations; and 30.4% reported worsening relations with their spouse. A lower frequency of intimate relations was related to: older age, female gender, higher BASDAI, spinal stiffness, higher functional limitation in intimate relations, higher psychological distress, self-reported diagnosis of depression, worsening relationship with spouse since disease onset, higher BMI, smoking, lack of physical activity, and lack of biologics use. In the multivariate regression analysis, the most strongly associated variables with lower frequency of intimate relations were: functional limitation in intimate relations (β = 0.218; 95% CI 0.185 – 0.251), worse relationship with spouse (β = 0.207; 95% CI = 0.165 - 0.250), female gender (β = 0.150; 95% CI 0.071 – 0.229), and no engaging in physical activity (β = -0.135; 95% CI -0.234 – -0.036) (Table 2).Conclusion:EMAS results reveal a great impact of axSpA on patients’ sexual life, with multiple sociodemographic, lifestyle and PROs being associated with a lower frequency of intimate relations.Table 1.Regression analysis to predict frequency of intimate relationsSimple linear regressionMultivariable stepwise linear regressionB95% CIpB95% CIpAge (Years)0.0070.004,0.010<0.0010.0100.007,0.013<0.001Gender (Female)0.2150.146,0.284<0.0010.1500.071,0.229<0.001BASDAI0.1240.107,0.141<0.0010.0290.007,0.0500.010Spinal Stiffness0.0890.075,0.102<0.001NANA0.214Functional Limitation – Intimate relations0.2970.271,0.323<0.0010.2180.185,0.251<0.001GHQ-120.0670.059,0.075<0.0010.0350.024,0.045<0.001Depression (Yes)0.3750.298,0.452<0.001NANA0.064Relationship with spouse0.3430.306,0.380<0.0010.2070.165,0.250<0.001BMI0.0170.011,0.024<0.0010.0080.001,0.0150.031Smoking (Yes)0.0750.002,0.1480.044NANA0.907Physical activity (Yes)-0.212-0.306,-0.119<0.001-0.135-0.234,-0.0360.007Biologics (Yes)0.1880.110, 0.267<0.001NANA0.185Acknowledgments:Funded by Novartis Pharma AGDisclosure of Interests:Marco Garrido-Cumbrera: None declared, Christine Bundy Grant/research support from: Has received unrelated honoraria from Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer., Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Souzi Makri: None declared, Raj Mahapatra: None declared, Sergio Sanz-Gómez: None declared, Laura Christen: None declared, Carlos Jesús Delgado-Domínguez: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB
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Garrido-Cumbrera, M., V. Navarro-Compán, C. Bundy, R. Mahapatra, S. Makri, S. Sanz-Gómez, L. Christen, C. J. Delgado-Domínguez, and D. Poddubnyy. "SAT0374 ONSET OF AXIAL SPONDYLOARTHRITIS REPERCUSSIONS ON PATIENTS’ SOCIAL AND FAMILY LIFE: RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1134.2–1135. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4293.
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Background:Axial Spondyloarthritis (axSpA) is associated with a high degree of functional limitation in daily life activities. However, few studies have evaluated the social and family burden from the patient’s perspective.Objectives:To describe the impact of axSpA on social and family life since disease onset, and the associated PROs.Methods:Data from 2,846 unselected patients of the European Map of Axial Spondyloarthritis (EMAS) study through an online survey (2017-2018) across 13 European countries were analysed. The impact of axSpA on social and family life were assessed through four PROs: i) Impact on relationships with the spouse, family, friends, neighbours, and work colleagues since disease onset (5 point Likert scale; 1 “much better” – 5 “much worse”; ii) Frequency of social activities including outings to bars/restaurants, cinema/theatre/museums, practising sports, travel/excursions, and intimate relations since disease onset (5 point Likert scale; 1 “much more” – 5 “much less”); iii) Adaptations made to cope with axSpA since disease onset (yes/no question); iv) The degree of functional limitation in 18 daily activities (3 point Likert scale). Self-reported BASDAI (0-10), spinal stiffness (3-12), functional limitation (0-54), and psychological distress (GHQ-12) were analysed using Pearson’s correlation comparing the impact on relationships and frequency of social activities since disease onset.Results:Among 2,846 participants, mean age was 43.9 years, 61.3% were female, 48.1% had a university degree. The greatest impact on relationships (sum of ‘worse’ and ‘much worse’) since disease onset were those with work-colleagues (44.5%), friends (35.6%), and spouse (30.4%). Sport was the activity they reduced the most since disease onset (64.2%), followed by travel/excursions (57.3%) and intimate relationships (56.4%) (Fig. 1). 55.5% had purchased comfortable shoes (N = 2748) and 43.9% had made adaptations to their workplace (N = 2651). For those who reported their level of functional limitation in daily activities, the greatest limitations were in physical exercise (85.5%), cleaning the house (84.4%) and using stairs (79.2%) (Fig. 2). In the correlation analysis, BASDAI, spinal stiffness, functional limitation, GHQ-12 were associated with a worsening in all of relationships and social activities (p < 0.001) (Table 1).Table 1.Pearson’s correlation between social and family life changes and PROsRelationships: 1 much better – 5 much worseBASDAISpinal StiffnessFunctional LimitationGHQ-12Spouse0.157*0.130*0.167*0.258*Family0.162*0.133*0.138*0.206*Friends0.211*0.173*0.180*0.282*Neighbours0.210*0.165*0.112*0.229*Work colleagues0.229*0.153*0.213*0.334*Frequency activities: 1 much more – 5 much lessBars / restaurants0.261*0.246*0.314*0.316*Cinemas / theatres / museums0.291*0.243*0.299*0.338*Do sports0.271*0.213*0.240*0.242*Travel / excursions0.308*0.218*0.307*0.362*Intimate relations0.284*0.254*0.288*0.321**p <0.001Figure 1.Reported social and family live changes since disease outsetFigure 2.Reported level of functional limitation in daily live activitiesConclusion:For most participants the onset of axSpA marked the worsening of personal relationships in different areas, as well as the reduction of social, leisure, and entertainment activities.Acknowledgments:Funded by Novartis Pharma AGDisclosure of Interests:Marco Garrido-Cumbrera: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Christine Bundy Grant/research support from: Has received unrelated honoraria from Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer., Raj Mahapatra: None declared, Souzi Makri: None declared, Sergio Sanz-Gómez: None declared, Laura Christen: None declared, Carlos Jesús Delgado-Domínguez: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB
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Deodhar, A., P. J. Mease, D. Poddubnyy, R. Calheiros, X. Meng, V. Strand, and M. Magrey. "FRI0271 IMPACT OF HLA-B27 STATUS ON CLINICAL OUTCOMES AMONG PATIENTS WITH ANKYLOSING SPONDYLITIS TREATED WITH SECUKINUMAB." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 721. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1448.
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Background:Ankylosing spondylitis (AS) is strongly associated with the genetic marker HLA-B27. Approximately 80%-90% of white patients with AS express HLA-B27 compared with < 8% of the general population. In patients with AS, negative HLA-B27 status is a predictor of worse response to TNFis.1The impact of HLA-B27 status on clinical efficacy of secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A, has not been studied.Objectives:To analyze the impact of HLA-B27 status on clinical outcomes at Week 16 in patients with AS treated with secukinumab vs placebo.Methods:Patients with AS were pooled from the MEASURE 1-4 studies (NCT01358175,NCT01649375,NCT02008916, andNCT02159053) and stratified by HLA-B27 status. All trials included patients who received secukinumab 150 mg every 4 weeks with or without an initial loading dose (10 mg/kg IV at Weeks 0, 2, 4 or 150 mg SC at Weeks 0, 1, 2, and 3) or placebo control. MEASURE 3 included patients receiving secukinumab 300 mg every 4 weeks following the initial IV loading dose. Efficacy at Week 16 was determined by the proportion of patients achieving ASAS20/40, ASAS5/6, ASAS partial remission, BASDAI50, ASDAS-CRP < 2.1, ASDAS-CRP < 1.3, and improvement in Patient Global Assessment (VAS) and total spinal/back pain (VAS) scores. In MEASURE 1, 2, and 4, quality of life (QOL) was assessed at Week 16 by the SF-36 PCS, SF-36 MCS, and ASQOL. ASAS, BASDAI, and ASDAS-CRP responses were analyzed by nonresponder imputation, and all other outcomes by mixed models for repeated measures. For hypothesis generation, outcomes at Week 16 with secukinumab vs placebo within HLA-B27 strata were compared by logistic regression analysis without adjustment for multiple comparisons.Results:Baseline characteristics were balanced across treatment groups, although more HLA-B27+ patients than HLA-B27− patients were male (71%-73% vs 43%-50%). HLA-B27+ patients receiving any dose of secukinumab were significantly more likely to achieve ASAS, BASDAI50, and ASDAS-CRP responses vs those receiving placebo (P< .05; Figure 1). HLA-B27− patients receiving secukinumab 300 mg were significantly more likely to achieve ASAS40, ASAS partial remission (Figure 1A), and BASDAI50 (Figure 1B) responses than those receiving placebo (P< .05). Patients receiving any dose of secukinumab were more likely to achieve ASAS5/6 and ASDAS-CRP < 2.1 than those receiving placebo, regardless of HLA-B27 status (P< .05; Figure 1B). All secukinumab-treated patients experienced significant improvement in Patient Global Assessment at Week 16 vs placebo, regardless of HLA-B27 status, while only HLA-B27+ patients experienced significant reduction in total spinal/back pain vs placebo (P< .05; Figure 2A). Numerical improvements in QOL were observed in all patients receiving secukinumab 150 mg vs placebo; these reached significance for HLA-B27+ patients (Figure 2B).Conclusion:Secukinumab is effective in patients with AS regardless of HLA-B27 status; HLA-B27+ patients may derive increased therapeutic benefit compared with HLA-B27− patients.Reference:[1]Alazmi M, et al.Arthritis Care Res (Hoboken). 2018;70:1393-9.Acknowledgments:This study was funded by Novartis Pharmaceuticals Corporation. The authors thank Rich Karpowicz, PhD, of Health Interactions, Inc, for providing medical writing support/editorial support, which was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).Disclosure of Interests:Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Renato Calheiros Shareholder of: Novartis, Employee of: Novartis, Xiangyi Meng Shareholder of: Novartis, Employee of: Novartis, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Marina Magrey Grant/research support from: AbbVie, Amgen, and UCB, Consultant of: Eli Lilly and Novartis
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Garrido-Cumbrera, M., D. Poddubnyy, L. Gossec, R. Mahapatra, C. Bundy, S. Makri, S. Sanz-Gómez, L. Christen, C. J. Delgado-Domínguez, and V. Navarro-Compán. "FRI0315 GENDER DIFFERENCES IN PATIENT JOURNEY TO DIAGNOSIS AND PATIENT-REPORTED OUTCOMES: RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 748–49. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4264.
Full textAbstract:
Background:Growing evidence of similarities in male-female prevalence of axial spondyloarthritis (axSpA) has stimulated the need to evaluate gender differences in patient experiences.Objectives:To evaluate gender differences in diagnostic journey, disease-characteristics and patient-reported outcomes (PROs) in axSpA patients.Methods:Data from 2846 unselected patients of the European Map of Axial Spondyloarthritis (EMAS) through an online survey (2017-2018) across 13 countries were analysed. Socio-demographic characteristics, diagnosis, disease-characteristics, and PROs [BASDAI (0-10), spinal stiffness (3-12), functional limitation (0-54) and psychological distress (0-12, GHQ-12)] were compared between genders. Χ2(for categorical variables) and student-t (for continuous variables) were employed.Results:1,746 (61.3%) females participated in the EMAS, with homogeneous gender distribution across most countries (Fig 1). Compared to males, females reported longer diagnostic delay (6.1±7.4 vs 8.2±8.9; p<0.001), more visits to physiotherapists (34.5% vs 49.5%; p<0.001) and osteopaths (13.3% vs 24.4%; p<0.001) before being diagnosed (Table 1), higher disease activity in all BASDAI items and greater functional limitation, psychological distress and self-reported anxiety and depression (Table 2).Table 1.Disease characteristics by gender (N: 2846, unless specified)Men (n: 1100)(mean ± SD or %)Women (n: 1746)(mean ± SD or %)p valueAge at onset of first symptoms, n: 272127.0 ± 11.826.4 ± 10.70.342Age at diagnosis, n: 272232.6 ± 12.234.4 ± 10.9<0.001Diagnostic delay, n: 26526.1 ± 7.48.2 ± 8.9<0.001Disease Duration, n: 271618.9 ± 13.316.1 ± 11.7<0.001HCP seen before diagnosis - General practitioner822 (74.7)1434 (82.1)<0.001 - Orthopaedic specialist377 (34.3)557 (31.9)0.190 - Physiotherapist380 (34.5)865 (49.5)<0.001 - Osteopath, n: 2166103 (13.3)339 (24.4)<0.001 - Other, n: 2220135 (14.0)233 (18.5)0.005Family history of axSpA (yes), n: 2244291 (33.5)584 (42.5)<0.001HLA-B27 (positive), n: 1799497 (80.2)786 (66.7)<0.001Uveitis (yes), n: 2096199 (25.2)270 (20.7)0.023IBD (yes), n: 2096113 (14.3)181 (13.9)0.688Table 2.PROs by gender (N: 2846, unless specified)Men (n: 1100)(mean ± SD or %)Women (n: 1746)(mean ± SD or %)p valueBASDAI, (0-10) n: 25845.1 ± 2.05.7 ± 1.9<0.001 - Fatigue, n: 26365.7 ± 2.46.6 ± 2.2<0.001 - Neck, back or hip pain, n: 26365.6 ± 2.46.2 ± 2.2<0.001 - Pain other than neck, back or hip, n: 26364.3 ± 2.74.9 ± 2.6<0.001 - Discomfort to touch or pressure, n: 26364.5 ± 2.75.6 ± 2.6<0.001 - Morning stiffness level, n: 26365.3 ± 2.65.9 ± 2.6<0.001 - Morning stiffness duration, n: 25844.5 ± 2.84.7 ± 2.80.070Stiffness, (3-12) n: 27077.7 ± 2.67.8 ± 2.40.107Functional Limitation, (0-54) n: 277119.1 ± 16.721.2 ± 16.0<0.001GHQ-12 ≥3, n: 2640564 (55.4)1060 (65.4)<0.001Anxiety243 (30.6)566 (43.3)<0.001Depression238 (30.1)472 (36.1)<0.001Figure 1.Countries’ sample distribution stratified by gender (N: 2846)Conclusion:Important gender differences are observed in axSpA such as a longer patient journey to diagnosis, poorer PROs, and greater psychological burden in females. These results point to unmet needs in females with axSpA, requiring particular attention.Acknowledgments:Funded by Novartis Pharma AGDisclosure of Interests:Marco Garrido-Cumbrera: None declared, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB, Raj Mahapatra: None declared, Christine Bundy Grant/research support from: Has received unrelated honoraria from Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer., Souzi Makri: None declared, Sergio Sanz-Gómez: None declared, Laura Christen: None declared, Carlos Jesús Delgado-Domínguez: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB
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Garrido-Cumbrera, M., C. Bundy, V. Navarro-Compán, L. Christen, R. Mahapatra, S. Makri, C. J. Delgado-Domínguez, D. Gálvez-Ruiz, P. Plazuelo-Ramos, and D. Poddubnyy. "POS0989 FACTORS ASSOCIATED WITH INABILITY TO WORK AND DISABILITY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS. RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 762.2–763. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2450.
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Background:Axial spondyloarthritis (axSpA) is associated with a high burden of disease, which may lead to inability to work and disability.Objectives:This analysis aims to identify factors associated with inability to work and disability among European axSpA patients.Methods:Data from 2,846 unselected patients participating in EMAS, a cross-sectional study (2017-2018) across 13 European countries were analysed. The sample was divided into those on permanent sick leave or with a recognised disability (Group 1) and those with neither permanent sick leave nor a recognized disability (Group 2). Mann-Whitney and Pearson’s χ2 tests were used to analyse possible differences between groups regarding sociodemographic characteristics, patient-reported outcomes [BASDAI (0-10), GHQ-12 (0-12), functional limitation (0-54) and spinal stiffness (3-12)], lifestyle habits, working life, and comorbidities). Univariable and multivariable binary logistic regression were used to analyse variables possibly explaining being on permanent sick leave and disability, for which 1,657 patients were included.Results:Mean age was 43.9 years, 61.3% were female, 48.1% had a university degree, and 67.9% were married. Patients in Group 1 (34.4%; n=978) were more likely to be women (54.3%), married (71.1%), with higher disease activity (BASDAI 5.9 vs. 5.3), functional limitation (25.1 vs. 18.0), spinal stiffness (8.6 vs. 7.3; all p<0.001), and longer diagnostic delay (8.1 vs 7.1 years; p = 0.01) than those in Group 2 (65.6%; n=1,868). In addition, 88.0% of Group 1 (n=728) had difficulties in finding a job due to axSpA throughout life; and more than 30.0% reported a diagnosis of anxiety, depression, or sleep disorders. Moreover, being in Group 1 was associated with higher functional limitation in all daily activities. In the multivariable binary logistic regression, the qualitative variables associated with permanent sick leave or disability were: difficulties finding work (OR= 2.52), belonging to a patient organisation (OR= 1.54) and work choice determined by axSpA (OR= 1.38). The quantitative variables associated with permanent sick leave or disability were: higher spinal stiffness (OR= 1.09), older age (OR= 1.03), longer disease duration (OR= 1.03), shorter diagnostic delay (OR= 0.98), and higher functional limitation (OR= 1.01) (Table 1).Table 1.Regression analysis for variables explaining being on permanent sick leave or disability (n=1,657)Univariable logistic analysisMultivariable logistic analysisQualitative variablesOR95% CI3OR95% CI3Gender11.571.34, 1.831.240.97, 1.57Educational level21.711.46, 2.001.080.86, 1.35Member of a patient organisation. Yes1.961.67, 2.291.541.23, 1.94Smoking. Yes1.281.08, 1.511.220.96, 1.55Difficulty finding job due to axSpA. Yes3.712.89, 4.772.521.83, 3.47Work choice determined by axSpA. Yes1.691.43, 1.991.381.09, 1.75Anxiety diagnosis. Yes1.271.07, 1.510.980.72, 1.34Depression diagnosis. Yes1.581.33, 1.891.250.92, 1.69Sleep disorder diagnosis. Yes1.331.13, 1.560.950.73, 1.23Quantitative variablesOR95% CI3OR95% CI3Age. Years1.041.03, 1.041.031.01, 1.04BASDAI (0-10)1.181.13, 1.241.060.98, 1.13Functional limitation (0-54)1.031.02, 1.031.011.00, 1.02Spinal stiffness (3-12)1.251.20, 1.291.091.03, 1.15Diagnostic delay1.011.01, 1.020.980.96, 0.99Disease duration1.041.03, 1.051.031.01, 1.041Male vs Female; 2No university studies vs university studies. 395% CI for test H0: OR=1Conclusion:One third of patients reported being on permanent sick leave or having a recognised disability. They were more likely to have higher spinal stiffness scores, were older in age, experiencing difficulty finding a job, and belonged to a patient organisation. Increased efforts in relation to early access to effective treatments and the creation of flexible working environments are essential for axSpA patients to continue working and remain active, which benefits their quality of life.Acknowledgements:This study was supported by Novartis Pharma AG.The authors would like to thank all patients who participated in this study.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Christine Bundy Consultant of: Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Laura Christen Employee of: Novartis Pharma AG, Raj Mahapatra: None declared, Souzi Makri: None declared, Carlos Jesús Delgado-Domínguez: None declared, David Gálvez-Ruiz: None declared, Pedro Plazuelo-Ramos: None declared, Denis Poddubnyy Consultant of: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Abbvie, MSD, Novartis, and Pfizer.
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Garrido-Cumbrera, M., V. Navarro-Compán, L. Christen, C. Bundy, R. Mahapatra, S. Makri, C. J. Delgado-Domínguez, J. Correa-Fernández, and D. Poddubnyy. "POS0961 PREVALENCE AND ASSOCIATED FACTORS OF SLEEP DISORDERS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS. RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 745. http://dx.doi.org/10.1136/annrheumdis-2021-eular.981.
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Background:Sleep is an essential health aspect that is often impacted in patients with axial spondyloarthritis (axSpA).Objectives:This analysis aims to assess the prevalence and associated factors of sleep disorders in a large sample of European axSpA patients.Methods:Data were analyzed from 2,846 unselected patients with self-reported clinician-given diagnosis of axSpA of the European Map of Axial Spondyloarthritis (EMAS) through an online survey (2017-2018) across 13 European countries. Socio-demographic data; BASDAI [0-10] scores; engagement in physical activity; axSpA influence on work choice (assessed with yes/no question “Was your current or past work choice in any way determined by axSpA?”); risk of psychological distress (12-item General Health Questionnaire [GHQ-12; 0-12]); functional limitation [0-54] and self-reported anxiety and depression were evaluated. Presence of sleep disorders was assessed by the question: “Please indicate whether you have been diagnosed with any of the following: sleep disorders”. A Mann-Whitney test was used to compare the means of numerical variables between dichotomous variables, the Chi-Square test was used to compare the distribution between the categorical variables. Simple and multivariable logistic regression models were used to identify associations between sleep disorders and disease characteristics, mental health and work-related variables.Results:Age of respondents was 43.9 years; 61.3% were female; 48.1% had a university degree; 67.9% were married and 71.3% were HLA-B27 positive. The prevalence of sleep disorders was 39.0%. In the bivariate analysis, presence of sleep disorders was associated with female gender (68.3% vs. 31.7%; p<0.001); overweight/obese (56.5% vs. 49.8%; p<0.001); increased BASDAI scores (6.1±1.8 vs. 5.0±2.1; p<0.001); fatigue (7.0±2.0 vs. 5.8±2.4; p<0.001); morning stiffness (5.8±2.4 vs. 4.8±2.4; p<0.001), work impact (56.5% vs. 38.2%; p< 0.001); anxiety (56.8% vs. 12.5%; p<0.001); depression (51.8% vs. 10.1%; p<0.001) and higher GHQ-12 scores (6.4±4.0 vs. 3.9±3.9; p<0.001). However, factors that remained independently associated with sleep disorders in the multivariable analysis were anxiety (OR=3.8 p<0.001) and depression (OR=3.1 p<0.001) and female gender (OR=1.4; p=0.002) [Table 1].Table 1.Regression analysis to predict presence of sleep disorders (N=2191)Simple logistic regressionMultivariable logistic regressionOR95% CIp-valueOR95% CIp-valueGender (female)1.591.36-1.87<0.0011.401.13-1.730.002Marital status (married)1.130.99-1.280.074NANANAOverweight/Obesity1.311.12-1.530.0011.391.14-1.710.001BASDAI (0-10)1.331.27-1.39<0.0011.070.95-1.210.246Fatigue/Tiredness (0-10)*1.281.23-1.33<0.0011.040.97-1.120.271Morning Stiffness intensity (0-10)*1.191.15-1.23<0.0011.050.98-1.130.188Reported Work impact (yes)2.101.78-2.48<0.0011.291.05-1.580.015Anxiety (yes)9.187.58-11.11<0.0013.842.99-4.94<0.001Depression (yes)9.537.78-11.66<0.0013.092.37-4.02<0.001GHQ-12 (0-12)**1.161.14-1.19<0.0011.031.00-1.060.029*As measured by the respective item of the BASDAI scale.**12-item General Health Questionnaire. A value of 3 or above indicates a risk of poor mental health.Conclusion:Sleep disorders were highly prevalent among axSpA European patients and strongly associated with female gender and reporting worse mental health, and spinal stiffness. Patients on permanent and temporary sick leave were more likely to report sleep disorders. The strong association between sleep disorders with both anxiety and depression should encourage rheumatologists to screen their patients with sleep disturbance in case they require additional specialist support.Acknowledgements:This study was supported by Novartis Pharma AG. The authors would like to thank all patients who participated in the study.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB., Laura Christen Employee of: Novartis Pharma AG, Christine Bundy Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer, Raj Mahapatra: None declared, Souzi Makri: None declared, Carlos Jesús Delgado-Domínguez: None declared, José Correa-Fernández: None declared, Denis Poddubnyy Speakers bureau: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Abbvie, MSD, Novartis, and Pfizer.
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Garrido-Cumbrera, M., D. Poddubnyy, L. Christen, C. Bundy, R. Mahapatra, S. Makri, S. Sanz-Gómez, J. Correa-Fernández, C. J. Delgado-Domínguez, and V. Navarro-Compán. "POS0065-PARE HEALTH IMPACT OF OVERWEIGHT AND OBESITY IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS. RESULTS FROM THE EUROPEAN MAP OF AXIAL SPONDYLOARTHRITIS (EMAS)." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 239.2–239. http://dx.doi.org/10.1136/annrheumdis-2021-eular.974.
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Background:Growing evidence on the negative role of overweight and obesity on the health outcomes of patients with axial spondyloarthritis (axSpA) exists.Objectives:The aim of the study is to evaluate the association between Body Mass Index (BMI) categories and sociodemographic, disease-characteristics and patient-reported outcomes (PROs) in a large sample of axSpA patients.Methods:Data from 2,846 unselected patients of the European Map of Axial Spondyloarthritis (EMAS) through an online survey (2017-2018) across 13 European countries were analyzed. Using self-reported height and weight patients were classified into under and normal weight (<24.9 Kg/m2), overweight (25.0-29.9Kg/m2) or obese (>30.0Kg/m2) following WHO guidelines. The Kruskal-Wallis test was used to compare the means of numerical variables between polytomous variables, the χ2 test was used to compare the distribution between the categorical variables. Simple and multivariate logistic regression were used to identify possible associated factors.Results:A total 2,846 axSpA patients participated in the EMAS survey: mean age was 43.9 years, 61.3% female, 48.1% had a university degree and 67.9% were married and 71.3% were HLA-B27 positive. The percentage of patients with obesity was 18.7%, overweight 33.5%, normal weight 44.0% and underweight 3.8% with an accumulate prevalence of overweight/obesity of 52.2% (compared to 51.6 % of the EU’s population1). Those with obesity engage less frequently in sport (50.1% vs 33.3%; p<0.001) and in intimate relationships since disease onset (36.5% vs 20.4%; p<0.001), have higher functional limitations when tying shoe laces (46.8% vs 33.6%; p<0.001) and higher functional limitations regarding housework (52.2% vs 48.2%; p=0.024). Furthermore, they present greater disease activity (6.1±1.8 vs 5.4±2.0; p<0.001) and spinal stiffness (8.6±2.3 vs 7.4±2.5; p<0.001) compared to under and normal weight. For obese patients, the percentage of depression is higher (34.5% vs 23.7%; p<0.001), presenting a poorer mental health (5.7 ± 4.3 vs 5.0 ±4.2; p<0.001). The factors most strongly associated with obesity were higher functional limitation when tying shoe laces (OR=1.467; p<0.001), the female gender (OR=1.433; p<0.001) and lesser frequency of intimate relation (OR=1.239; p<0.001; see Table 1).Table 1.Logistic regression analysis to predict presence of obesity (N = 1,194)SimpleMultivariateOR95% CIp-valueOR95% CIp-valueAge1.0261.018, 1.034<0.0011.0261.012, 1.040<0.001Gender (female)1.3361.095, 1.6290.0041.4331.031, 1.9900.032Marital status (married)1.3841.184, 1.617<0.0010.9820.746, 1.2920.897Educational level (university)0.7760.681, 0.884<0.0011.0460.849,1.2890.674Employment status (employed)1.0350.987, 1.0850.154NANANAEngage in sports (much less than before)1.3131.202, 1.433<0.0011.1430.978, 1.3360.093Travel/ excursions (much less than before)1.3161.186, 1.461<0.0010.9810.800, 1.2020.852Intimate relations (much less than before)1.5711.393, 1.772<0.0011.2391.003, 1.5300.047Tying shoe laces (high)1.4331.232, 1.666<0.0011.4671.176, 1.8300.001Housework / cleaning (high)1.2261.048, 1.4340.0110.7600.596, 0.9700.028BASDAI (0-10) N:2,5841.2201.156, 1.288<0.0011.1271.021, 1.2440.018Spinal Stiffness (3-12) N:2,6601.1841.136, 1.234<0.0011.0570.987, 1.1330.115Sleep disorders diagnosis1.5581.284, 1.892<0.0011.0450.753, 1.4490.793Depression diagnosis1.6481.340, 2.027<0.0011.2670.892, 1.7990.186Psychological distress GHQ-12 (0-12)1.0531.029, 1.078<0.0010.9950.954, 1.0380.813Conclusion:Results from the largest European axSpA survey reveal a similar prevalence of overweight and obesity to the general population. However, compared to normal weight, obese patients present greater disease activity, spinal stiffness and poorer mental health. Additionally, women with axSpA appear to be more vulnerable than men to obesity.References:[1]EU Eurostat. Overweight and obesity - BMI statistics.Acknowledgements:This study was supported by Novartis Pharma AG. The authors would like to thank all patients who participated in the study.Disclosure of Interests:Marco Garrido-Cumbrera: None declared, Denis Poddubnyy Speakers bureau: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: Abbvie, MSD, Novartis, and Pfizer, Laura Christen Employee of: Novartis Pharma AG, Christine Bundy Speakers bureau: Abbvie, Celgene, Janssen, Lilly, Novartis, and Pfizer, Raj Mahapatra: None declared, Souzi Makri: None declared, Sergio Sanz-Gómez: None declared, José Correa-Fernández: None declared, Carlos Jesús Delgado-Domínguez: None declared, Victoria Navarro-Compán Grant/research support from: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, and UCB.