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Johnson-Roehr, Susan N. "Centering the Chārbāgh." Journal of the Society of Architectural Historians 72, no. 1 (March 1, 2013): 28–47. http://dx.doi.org/10.1525/jsah.2013.72.1.28.
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In Centering the Chārbāgh: The Mughal Garden as Design Module for the Jaipur City Plan, Susan N. Johnson-Roehr argues that the privileging of a Hindu-Vedic worldview has had a significant effect on our understanding of Jaipur City’s history. Current interpretive approaches assume that the city’s patron, Sawai Jai Singh II, relied on the maṇḍala when shaping the city plan in the eighteenth century. The emphasis on the maṇḍala as governing device has encouraged historians to neglect other sources of Jaipur’s city plan. Specifically, scholars have not considered the role of the quadripartite Mughal paradise garden (chahār bāgh, Persian; chārbāgh, Hindi) in the planning of the city. Johnson-Roehr suggests that Jaipur’s spatial organization was defined by the chārbāgh rather than the navagraha or vāstu puruṣa maṇḍala, and demonstrates that the plan was a response to a specific chārbāgh, Jai Niwas Bagh, built by Sawai Jai Singh in 1713. Combining a rereading of eighteenth-century documents with an analysis of the physical characteristics of Jai Niwas Bagh, the author concludes that the chārbāgh was the most important element in the development of the rectilinear boulevards, bazaars, and walls that characterize Jaipur today.
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Lunning, Matthew A., Jason Gonsky, Jia Ruan, Adrienne A. Phillips, Melissa Pulitzer, Alison Moskowitz, Christiane Querfeld, Patricia L. Myskowski, Ariela Noy, and Steven M. Horwitz. "Pralatrexate in Relapsed/Refractory HTLV-1 Associated Adult T-Cell Lymphoma/Leukemia: A New York City Multi-Institutional Experience." Blood 120, no. 21 (November 16, 2012): 2735. http://dx.doi.org/10.1182/blood.v120.21.2735.2735.
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Abstract Abstract 2735 Introduction: Adult T-cell lymphoma/leukemia (ATLL) is a mature T-cell malignancy associated with human T-cell lymphotropic virus -1 (HTLV-1) infection, which presents as aggressive (acute/lymphomatous) or indolent (chronic/smouldering) subtypes. The aggressive subtypes have a median survival of 6 months. Further, there is no established therapy for patients with relapsed/refractory disease. Pralatrexate is a dihydro-folate reductase inhibitor with high affinity for the reduced folate carrier type 1, a protein involved in trafficking of native folates. Pralatrexate given weekly at 30 mg/m2 for six of seven weeks was the first drug approved for use in relapsed/refractory peripheral T-cell lymphoma (PTCL) after demonstrating an overall response rate (ORR) of 29%. However, only one patient in the pivotal PROPEL study had ATLL. Approaches for relapsed/refractory PTCL are often applied to ATLL, as there is little data for this subtype. Here, we report a multi-institutional retrospective experience of pralatrexate in relapsed/refractory ATLL focusing on efficacy, durability, and toxicity. Methods: To investigate the therapeutic benefit and toxicity profile of pralatrexate we reviewed all patients with relapsed/refractory ATLL treated with pralatrexate on published trials or treated off study between 2005 and 2012 at three New York City institutions. Individual chart review was performed to report clinicopathologic features, treatment outcomes, and toxicity assessments. An event was defined as toxicity from pralatrexate resulting in discontinuation, progression, or death. Results: We identified 21 patients with relapsed/refractory ATLL treated with pralatrexate. Patient characteristics were: median age 52 (range 37–74); male:female 9:12; Region of origin was Caribbean-18, non-Caribean-3. Subtype at diagnosis of ATLL was: Acute/Lymphomatous-17 and Smouldering/Chronic-4. The median number prior treatments were 1 (range 0–5). Seven patients were treated on pralatrexate developmental clinical trials with one patient on the pivotal phase II PROPEL study. The median dose and number of treatments administered were 30 mg/m2 (range 15–45) and 4 (range 1–53) respectively. The ORR in patients evaluable for response (N=16) was 19% (2:PR; 1:CR) with an intent-to-treat (N=20) ORR was12% in patients with any exposure to pralatrexate. The median duration of response was 15 weeks (range 11–83). The median event free survival (EFS) was 6 weeks (range 1 to 90). One patient continues on pralatrexate without toxicity and has yet to be evaluated for response. Four patients (19%) developed findings consistent with Stevens-Johnson Syndrome (SJS) after 1 (N=2) or 2 (N=2) doses of pralatrexate. One additional patient developed a papular rash after pralatrexate; no biopsy was obtained. In the four patients with SJS, one had skin involvement of ATLL at diagnosis and at the time of pralatrexate, two had cutaneous ATLL lesions at the time of pralatrexate, and one did not have any cutaneous ATLL. Dermal apoptosis of tumor was not assessed in any of the cases. Seven patients (33%) developed clinically significant mucositis with two cases in patients with SJS. Conclusion: ATLL is a rare and difficult disease to manage. In our retrospective experience in relapsed/refractory ATLL, pralatrexate appears to have inferior ORR and much shorter EFS when compared to other PTCL subtypes. Notably, the risk of SJS, even without cutaneous involvement by lymphoma, may be higher in ATLL. In early phase studies of pralatrexate skin erosions were also seen in patients with PTCL with cutaneous involvement, including one cases of an ATLL patient with in vivo evidence of apoptosis of cutaneous tumor cells, but no cases of SJS were reported. A dedicated phase II study of pralatrexate in relapsed/refractory ATLL is planned by the Japan Clinical Oncology Group. Disclosures: Horwitz: Seattle Genetics: Consultancy, Research Funding; Allos: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy; Genzyme: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy; Johnson & Johnson: Consultancy; Infinity Pharmaceuticals, Inc.: Research Funding.
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Gladman, D. D., P. J. Mease, P. Bird, E. Soriano, S. D. Chakravarty, M. Shawi, S. Xu, et al. "AB0894 Efficacy and Safety of Guselkumab in Biologic-Naïve Patients With Active Axial Psoriatic Arthritis: Study Design of a Phase 4, Randomized, Double-Blind, Placebo-Controlled Trial." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1574–75. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1551.
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BackgroundEstablished criteria for classifying axial psoriatic arthritis (PsA) are lacking, and assessments of disease activity often rely on measures developed for ankylosing spondylitis (AS). There is an unmet need to systematically identify and measure efficacy of treatments for axial PsA patients (pts). Guselkumab (GUS), a selective interleukin (IL)-23p19 inhibitor, was efficacious in improving signs and symptoms of active PsA in 2 phase 3, randomized, placebo (PBO)-controlled studies: DISCOVER-1 and DISCOVER-2. In a post-hoc pooled analysis of DISCOVER-1&2 pts with investigator-confirmed sacroiliitis, GUS-treated pts had greater improvements in axial symptoms compared with PBO.1 Imaging in DISCOVER-1&2 was restricted to the sacroiliac (SI) joints, occurring prior to/at screening as confirmed by the investigator, and locally read.ObjectivesTo design a new, dedicated study to evaluate the effects of GUS on axial PsA prospectively.MethodsCumulative evidence from DISCOVER-1&2, including exposure–response relationship, covariate adjustment for modest baseline imbalances across treatment groups, subgroup analyses, and comparisons within and across these studies, was considered in designing a new trial. Data from the pivotal registrational studies suggest similar efficacy with GUS every-4-weeks (Q4W) and Q8W regimens in treating PsA signs and symptoms, including symptoms of axial involvement. Power calculations were based on mean changes in Bath AS Disease Activity Index (BASDAI) scores in DISCOVER-1&2.ResultsThe phase 4, randomized, PBO-controlled STAR study is specifically designed to prospectively assess efficacy outcomes in PsA pts with magnetic resonance imaging (MRI)-confirmed axial inflammation. Based on observed mean (SD) changes from baseline in BASDAI score from DISCOVER-1&2 (Table 1), 405 pts, randomized (1:1:1) to GUS Q4W, GUS at W0, W4, then Q8W, or PBO →GUS Q8W at W24, are planned for enrollment (Figure 1). STAR eligibility criteria include PsA ≥6 months and active disease (≥3 swollen & ≥3 tender joints, C-reactive protein [CRP] ≥0.3 mg/dL) despite prior non-biologic disease-modifying antirheumatic drugs, apremilast, and/or non-steroidal anti-inflammatory drugs. Pts will be naïve to biologics and Janus kinase inhibitors and have BASDAI ≥4, spinal pain score (visual analog scale [VAS]) ≥4, and screening MRI-confirmed axial disease (positive spine and/or SI joints defined as centrally read Spondyloarthritis Research Consortium of Canada [SPARCC] score ≥3). Follow-up MRIs of spine and SI joints will be obtained at W0, W24, and W52 and also centrally read, with readers blinded to treatment group and timepoint. Spinal/SI joint inflammation will be scored using the SPARCC method, with the former also assessed using the CAN-DEN method. The primary endpoint is mean change in BASDAI at W24; controlled (hierarchical) secondary endpoints, all at W24, include AS Disease Activity Score (ASDAS-CRP), Disease Activity Index for PsA (DAPSA), ≥40% improvement in Assessment in AS criteria (ASAS40), and mean changes in spine/SI joint SPARCC scores.Table 1.Power calculations for the primary endpoint in the Phase 4 STAR study.Historical trial data*Observed mean (SD) change in BASDAI from W0-24Effect sizePower(N=135; α=0.05)**PBO-1.28 (2.24)GUS 100 mg Q4W-2.51 (2.00)1.23>99%GUS 100 mg Q8W-2.61 (2.47)1.33>99%* From the pooled DISCOVER-1&2 trials**Power calculations based on N=135 per study group (1:1:1 randomization) and 2-sided significance of 0.05 using a 2-sample T-test assuming equal variancesBASDAI, Bath Ankylosing Spondylitis Disease Activity Index; GUS, guselkumab; PBO, placebo; Q4W, every 4 weeks; Q8W, every 8 weeks; SD, standard deviation; W, weekConclusionThe phase 4 STAR study will allow for an in-depth, prospective evaluation of the effects of selectively inhibiting the IL-23p19 subunit with GUS in pts with MRI-confirmed axial PsA.References[1]Mease, et al. Lancet Rheum. 2021;3(10):e715-e723.Disclosure of InterestsDafna D Gladman Consultant of: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Abbvie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Philip J Mease Speakers bureau: AbbVie, Aclaris, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Grant/research support from: AbbVie, Aclaris, Amgen, BMS, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Paul Bird Speakers bureau: AbbVie, Eli Lilly, Gilead, Janssen, MSD, Pfizer, and UCB, Consultant of: Eli Lilly, Gilead, Janssen, Novartis, and Pfizer, Enrique Soriano Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Janssen, Novartis, and Roche, Grant/research support from: AbbVie, Janssen, Novartis, Pfizer, Roche, and UCB, Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Stephen Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Sean Quinn Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Cinty Gong Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Evan Leibowitz Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, Lai-Shan Tam Consultant of: Janssen, Pfizer, Sanofi, AbbVie, Boehringer Ingelheim, and Lilly, Grant/research support from: Amgen, Boehringer Ingelheim, Janssen, GSK, Novartis, and Pfizer, Philip Helliwell Speakers bureau: AbbVie, Janssen, and Novartis, Consultant of: Galapagos and Janssen, Grant/research support from: AbbVie, Janssen, and Pfizer, Arthur Kavanaugh Consultant of: Abbvie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Atul Deodhar Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Glaxo Smith & Kline, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, Glaxo Smith & Kline, Novartis, Pfizer, and UCB, Mikkel Østergaard Speakers bureau: AbbVie, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Consultant of: AbbVie, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, and Novartis, Xenofon Baraliakos Speakers bureau: AbbVie, Biocad, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Biocad, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Biocad, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB
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Sickels, Carter. "Johnson City." Appalachian Heritage 42, no. 2 (2014): 34–52. http://dx.doi.org/10.1353/aph.2014.0029.
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Saleh, Mansoor N., James B. Bussel, Raymond SM Wong, Balkis Meddeb, Abdulgabar Salama, Ali El-Ali, Erhard Quebe-Fehling, and Abderrahim Khelif. "Hepatobiliary and Thromboembolic Events during Long-Term E.X.T.E.N.Ded Treatment with Eltrombopag in Adult Patients with Chronic Immune Thrombocytopenia (ITP)." Blood 128, no. 22 (December 2, 2016): 1368. http://dx.doi.org/10.1182/blood.v128.22.1368.1368.
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Abstract Introduction: ITP, characterized by a reduction in platelets leading to thrombocytopenia, which persists for >12 months is considered chronic (cITP). Eltrombopag is an oral thrombopoietin receptor agonist approved for treatment of patients with cITP aged ≥1 year refractory to other treatments (eg corticosteroids, immunoglobulins). The recently completed Phase III EXTEND (Eltrombopag eXTENded Dosing) study was a global, open-label, extension study of patients with cITP, who received eltrombopag or placebo in prior eltrombopag clinical studies. The primary objective of EXTEND was to describe the long-term safety and tolerability of eltrombopag treatment in these patients. Here, we examine the occurrence of hepatobiliary and thromboembolic events (TEEs) as adverse events (AEs) of special interest in this study. Methods :Adult patients (≥18 years old) diagnosed with cITP according to ASH/BCSH guidelines were enrolled and received eltrombopag starting at 50 mg/day. Dose was titrated to 25-75 mg per day or less often as required, based on individual platelet count responses (targeted range ≥50-200x109/L). Patients who received 2 years of treatment and transitioned off eltrombopag due to commercial availability of eltrombopag were considered to have completed the study, whether or not they continued treatment with eltrombopag. The primary endpoint included detection and documentation of investigator-reported AEs, which included hepatobiliary AEs and TEEs. Analyses were conducted using the safety population, defined as all subjects who entered the study and had taken at least one dose of the study medication. Results:302 patients were enrolled and received at least one dose of eltrombopag: 67% were female; 38% splenectomized; 49% aged 18-49 years. Median duration of exposure was 2.4 years (range, 2 days to 8.8 years) and mean average daily dose was 50.2 (range, 1-75) mg/day. Overall, 259/302 (86%) achieved platelet counts of ≥50×109/L at least once during the study and 126/248 (51%) patients maintained continuous platelet counts ≥50×109/L for at least 31 weeks. Incidence of bleeding symptoms (WHO grades 1-4) generally decreased over time in patients with available data, from 57% (n=171/302) at baseline to 16% at 1 year (n=13/80), and 21% (12/58) at 2 years. 45 (15%) patients experienced at least one hepatobiliary AE, with the highest incidence within the first year of treatment (Figure A). AEs of increased ALT or AST led to the discontinuation of five and three patients, respectively and four patients discontinued due to an AE of increased blood bilirubin. Nine patients experienced ALT and/or AST >3 x upper limit of normal (ULN) and total bilirubin >1.5xULN. 19 (6.3%) patients experienced a total of 23 TEEs. Most events occurred in the first year (Figure B), and none after year 4. TEEs included deep vein thrombosis (n=6), cerebral infarction (stroke) [n=3], myocardial infarction (n=4), transient ischemic attack (n=2), others (n=8, 1 occurrence of each). A clear association with elevated platelet counts was not observed. Platelets >200x109/L at the time of the TEE were recorded in 8/19 patients; 6/19 experienced the TEE at or shortly after achieving their maximum platelet count. In total, 10 patients discontinued because of TEEs. Conclusions: Long-term treatment with eltrombopag in patients with cITP led to sustained platelet increases and reduced bleeding symptoms. The highest incidences of hepatobiliary AEs and TEEs occurred during the first year of treatment, though several events were recorded after 3 years of therapy. Long-term eltrombopag therapy was well-tolerated with a positive benefit-risk relationship in adults with cITP, with decreasing events after the first year of treatment. Disclosures Saleh: GSK: Consultancy, Research Funding, Speakers Bureau. Bussel:Amgen, Novartis & GSK: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer Ingleheim, Prophylix Pharma, Protalex, Rigel Pharmaceuticals: Research Funding; Momenta Pharmaceuticals, Novartis, Prophylix Pharma, Protalex, Rigel Pharmaceutical: Membership on an entity's Board of Directors or advisory committees; UptoDate: Patents & Royalties; Physicians Education Resource: Speakers Bureau. Wong:Bayer, Biogen-Idec and Novartis: Consultancy; Bayer, Biogen-Idec, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Pfizer, and Roche: Research Funding; Biogen-Idec and Novartis: Membership on an entity's Board of Directors or advisory committees. El-Ali:Novartis: Employment. Quebe-Fehling:Novartis: Employment.
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Hyman, Larry M. "Nasal consonant harmony at a distance the case of Yaka." Studies in African Linguistics 24, no. 1 (June 1, 1995): 6–30. http://dx.doi.org/10.32473/sal.v24i1.107408.
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In a number of Bantu languages the [d-l] reflex of Proto-Bantu *-Vd- suffixes alternates with [n] when the consonant of the preceding syllable is nasal, e.g., /dim-id-/ 'cultivate for' ~ [dim-in-]. Because these Bantu languages do not allow nasalized vowels, it is necessary to view such assimilation as operating "at a distance" [Poser 1983], with the intervening vowel(s) being transparent. Transvocalic nasal consonant harmony (NCR) is widespread within Bantu [Greenberg 1951], and was repeatedly cited by phonologists in the 1970's, e.g., from Luba [Howard 1972, Johnson 1972] and Lamba [Kenstowicz and Kisseberth 1979]. In this paper I treat a more extensive and dramatic case of NCR at a distance in Yaka, a language spoken in Zaire. In this language /-Vd-/ suffixes are realized [-Vn-] even when the triggering nasal consonant is not in the immediately preceding syllable, e.g., /-miituk-id-/ 'sulk for' ~ [miituk-in-] (cf. Ao [1991], Piggott [1993] and Odden [1994], who cite parallel facts from Kongo). I begin by documenting the pervasiveness of the (stem-level) nasal harmony effects in the language, which therefore require a phonological analysis (vs. one involving allomorphy). Discussion centers around the problem of why voiceless and prenasalized consonants should be transparent to NCR.
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Tankard, P. "Johnson and the Walkable City." Eighteenth-Century Life 32, no. 1 (January 1, 2008): 1–22. http://dx.doi.org/10.1215/00982601-2007-009.
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Shouse, Geoffrey, Sylvia O. Dulan, Jamie Wagner, Michelle Mott, Alex Ly, Donna Ujiiye, Mary C. Clark, et al. "Real World Evaluation of Deviation Outcomes in an Immune Effector Cell Quality Program." Blood 136, Supplement 1 (November 5, 2020): 10. http://dx.doi.org/10.1182/blood-2020-143412.
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Introduction City of Hope (COH) was one of the first institutions to be granted Immune Effector Cell (IEC) Therapy accreditation by the Foundation for the Accreditation of Cellular Therapy, which supports our mission to provide safe, high quality patient care through expanded standardization. As part of the accreditation requirements, COH expanded established processes developed to monitor standard of care (SOC) deviations for the Hematopoietic Cell Transplantation Program to our IEC Clinical Program. As part of process improvement, we monitored our IEC Quality program to determine if there were any outcome changes as a result of deviations. Therefore, we performed a retrospective analysis of electronically submitted SOC deviations for patients treated with commercially available chimeric antigen receptor (CAR) T cell products (tisagenlecleucel or axicabtagene ciloleucel [Axi-cel]) between December 2017- March 2020 at COH. Methods During the reporting timeframe, 122 patients were planned to be treated with an IEC product. We retrieved 28 requests for SOC deviations from our electronic database for 24 of 122 patients. We analyzed for volume, trends and patient outcomes of submitted deviation requests, including trends in type of deviation, transfer to the intensive care unit (ICU), length of inpatient hospital stay and safety outcomes at 30 days post infusion. Patients who did not receive their SOC product for any reason during the reporting timeframe, or were lost to follow-up were excluded from the outcomes analysis. Results Sixteen of 24 patients were planned to be treated with SOC Axi-cel and 8 of 24 patients were planned to be treated with tisagenlecleucel; only 19 of 24 patients (10 women and 9 men) underwent infusion with their respective SOC product, 15 with Axi-cel and 4 with tisagenlecleucel. Five of 24 patients, including 1 Axi-cel and 4 tisagenlecleucel patients were excluded due to change in medical condition or infusion after the reporting timeframe. We identified elevated creatinine levels as the most common reason for SOC deviation requests for patients to be treated with tisagenlecleucel (4 of 8 patients), while deviations relating to rest days between lymphodepletion and CAR T cell infusion were the most common submitted deviations for patients planned to be treated with Axi-cel (9 of 16 patients). We also descriptively compared patients who required SOC deviations to a cohort of patients (n=98) who did not require deviations and were treated with either axicabtagene ciloleucel (n=86) or tisagenlecleucel (n=12) during the same timeframe. Eight of 98 (8%) of patients who did not have requests for SOC deviation were transferred to the ICU compared to 4 of 19 (21%) patients who required SOC deviations. Seventeen of 19 and 94 of 98 patients were discharged. The median length of inpatient hospital stay post infusion for SOC deviations cohorts who were discharged was 16 days (11-40) and 15 days (8-100) for non-SOC deviations patients. When we descriptively compared survival outcomes at 30 days post infusion, we found that all (4 of 4) patients who required SOC deviations and received tisagenlecleucel survived compared to 11 of 12 patients without SOC deviations. For patients who received Axi-cel, 14 of 15 patients with SOC deviations survived at day 30 post infusion compared to 85 of 86 patients without SOC deviations. The response to treatment and toxicities will be reported at the meeting. Conclusion These data suggest that careful selection of patients who may benefit from SOC deviations and still receive their infusion may not negatively affect survival outcomes at 30 days. The SOC deviation review process offers physicians a forum to evaluate non-SOC eligible cases and advise on SOC policy changes. While preliminary, our quality review identifies a role for comprehensive analysis of all IEC SOC deviations as part of standard practice, especially as the field of cellular immunotherapy expands to include more SOC cellular products. Overall, further monitoring of SOC deviations in real world patient populations treated with commercially available IEC products will allow us to continue to support patient safety, assess patient care management practices, expand patient access, meet accreditation standards and monitor SOC practice changes while advancing the field of cellular immunotherapy. Disclosures Shouse: Kite Pharma: Honoraria, Speakers Bureau. Mott:Janssen/Johnson & Johnson: Consultancy; Juno/BMS: Consultancy. Budde:Gilead Sciences: Consultancy; AstraZeneca: Research Funding; Merck: Research Funding; Mustang Therapeutics: Research Funding; Kite, a Gilead Company: Consultancy; Roche: Consultancy; Amgen: Research Funding.
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Schanz, Julie, Fischer Stephanie, Claudia Haferlach, Georgia Bardi, Marilyn L. Slovak, Virginie Eclache, Bertil Johansson, et al. "Unrelated Clones In Myelodysplastic Syndromes and Acute Myeloid Leukemia - Characterization and Prognostic Relevance." Blood 116, no. 21 (November 19, 2010): 4022. http://dx.doi.org/10.1182/blood.v116.21.4022.4022.
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Abstract Abstract 4022 Introduction: The occurrence of cytogenetically-unrelated clones is a rare but recognized event in haematological malignancies that may appear at either presentation or in further progression of disease. As yet, little is known about the composition and prognostic relevance of unrelated clones in MDS and AML. The aim of this retrospective study was to analyze cases of unrelated clones in a large, multicentric and international study to further characterize their clinical relevance in myeloid disorders. Patients/Methods: A total of 95 patients with unrelated clones and their corresponding clinical data were collected from 10 different databases: MLL (n=30), German-Austrian-Swiss (16), Athens (11), City of Hope (10), Bobigny (6), Lund (5), Tokyo (5), Spanish (4), IMRAW (3), and Dortmund (2). 77 pts. (81.1%) had a diagnosis of primary MDS, 5 (5.3%) t-MDS, 9 (9.5%) de novo AML, and 4 (4.2%) AML following MDS. Abnormalities detected FISH only were excluded. Unrelated clones were defined as two abnormal clones that were not evolvable from each other. Overall survival and the risk of AML transformation was calculated. For comparison MDS cases without unrelated clones were included from the international MDS database, including 2901 pts. with primary MDS. Result: Two unrelated clones were seen in 80 pts. (84%), three in 14 (15%) and five in 1 patient (1%). The majority of cases showed one aberration per clone (84.5%). The most frequent single aberration was +8 (43.2%), followed by del(5q) (28.4%). Other anomalies were -7/del(7q) (14.7%), -Y (12.6%), del(20q) (9.5%), +21 (7.4%), i(17q) (5.3%) and del(9q) (5.3%). Complex aberrations were identified in 3/95 cases (3.2%) only. Patients with unrelated clones showed an overrepresentation of +8 (p<0.0001), -Y (p=0.031) and i(17q) (p=0.013) in comparison to patients without unrelated clones. A combination of del(5q) and +8 was observed in 13/95 (13.7%) cases. Other recurrent combinations were: -7/+8 (n=2; 2.1%), -Y/del(5q) (n=2; 2.1%) and del(5q)/20q- (n=2; 2.1%). Translocations occurred only in single cases. The median survival of all patients with unrelated clones was 26.5 months, a finding consistent with an intermediate prognosis. Patients with a +8 clone and a clone with any other aberration showed a median survival of 21.0 months. Combinations of del(5q)/+8 (median 45.8 months) as compared to isolated del(5q) showed no significant difference in survival and in comparison to cases with +8 plus a clone with any other aberration, led to a significantly better survival (p=0.004). Summary: Our data presents the largest series of MDS/AML patients showing unrelated clones published to date. While the most frequent combination del(5q)/+8 is associated with a favourable outcome, all other combinations have to be assigned to the intermediate risk group until further distinct combinations can be evaluated. Further data will be presented in detail. Disclosures: Haferlach: MLL Munich Leukemia Laboratory: Employment, Equity Ownership. Slovak:PerkinElmer: Employment. Ohyashiki:Nippon Shinyaku Co., Ltd.: Research Funding. Giagounidis:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees. Bennett:Johnson & Johnson: Consultancy.
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Schafer, Frederick C., Joseph F. Bridger, and Noral D. Stewart. "St. Mary’s Catholic Church, Johnson City, TN." Journal of the Acoustical Society of America 119, no. 5 (May 2006): 3370. http://dx.doi.org/10.1121/1.4786533.
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Chen, Hua-yan, Elijah J. Talamas, Alejandro A. Valerio, Lubomír Masner, and Norman F. Johnson. "Revision of the World species of the genus Chromoteleia Ashmead (Hymenoptera, Platygastridae, Scelioninae)." ZooKeys 778 (August 1, 2018): 1–95. http://dx.doi.org/10.3897/zookeys.778.25775.
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The genusChromoteleiaAshmead is revised. Twenty-seven species are recognized, of which six species are redescribed:C.congoana(Risbec),C.connectensKieffer,C.fuscicornisKieffer,C.longitarsisKieffer,C.semicyaneaAshmead,C.tricarinataKieffer; and twenty-one species are described as new:C.aequalisChen & Johnson,sp. n.,C.alternataChen & Johnson,sp. n.,C.bidensChen & Masner,sp. n.,C.copiosaChen & Johnson,sp. n.,C.cuneusChen & Johnson,sp. n.,C.curtaChen & Johnson,sp. n.,C.depilisChen & Johnson,sp. n.,C.disparChen & Masner,sp. n.,C.fengChen & Johnson,sp. n.,C.fossaChen & Johnson,sp. n.,C.ingensChen & Masner,sp. n.,C.levitasChen & Johnson,sp. n.,C.longaChen & Johnson,sp. n.,C.mauraChen & Masner,sp. n.,C.parvitasChen & Johnson,sp. n.,C.pilusChen & Johnson,sp. n.,C.planaChen & Johnson,sp. n.,C.raraChen & Johnson,sp. n.,C.robustaChen & Johnson,sp. n.,C.semiluteaChen & Johnson,sp. n.,C.sparsaChen & Johnson,sp. n.ChromoteleiarufithoraxKieffer remains a valid species, but its identity and status are unclear. All species are known only from the Neotropical region except forChromoteleiacongoana(Resbec) which only occurs in Africa.
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Barford, David, and David I. Stuart. "Louise N. Johnson 1940–2012." Nature Structural & Molecular Biology 19, no. 12 (December 2012): 1216–17. http://dx.doi.org/10.1038/nsmb.2464.
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Johnson-Lynn, S. E., A. W. McCaskie, A. P. Coll, and A. H. N. Robinson. "Neuroarthropathy in diabetes: pathogenesis of Charcot arthropathy." Bone & Joint Research 7, no. 5 (May 2018): 373–78. http://dx.doi.org/10.1302/2046-3758.75.bjr-2017-0334.r1.
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Charcot neuroarthropathy is a rare but serious complication of diabetes, causing progressive destruction of the bones and joints of the foot leading to deformity, altered biomechanics and an increased risk of ulceration. Management is complicated by a lack of consensus on diagnostic criteria and an incomplete understanding of the pathogenesis. In this review, we consider recent insights into the development of Charcot neuroarthropathy. It is likely to be dependent on several interrelated factors which may include a genetic pre-disposition in combination with diabetic neuropathy. This leads to decreased neuropeptides (nitric oxide and calcitonin gene-related peptide), which may affect the normal coupling of bone formation and resorption, and increased levels of Receptor activator of nuclear factor kappa-B ligand, potentiating osteoclastogenesis. Repetitive unrecognized trauma due to neuropathy increases levels of pro-inflammatory cytokines (interleukin-1β, interleukin-6, tumour necrosis factor α) which could also contribute to increased bone resorption, in combination with a pre-inflammatory state, with increased autoimmune reactivity and a profile of monocytes primed to transform into osteoclasts - cluster of differentiation 14 (CD14). Increased blood glucose and loss of circulating Receptor for Advanced Glycation End-Products (AGLEPs), leading to increased non-enzymatic glycation of collagen and accumulation of AGLEPs in the tissues of the foot, may also contribute to the pathological process. An understanding of the relative contributions of each of these mechanisms and a final common pathway for the development of Charcot neuroarthropathy are still lacking. Cite this article: S. E. Johnson-Lynn, A. W. McCaskie, A. P. Coll, A. H. N. Robinson. Neuroarthropathy in diabetes: pathogenesis of Charcot arthropathy. Bone Joint Res 2018;7:373–378. DOI: 10.1302/2046-3758.75.BJR-2017-0334.R1.
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CHARUWAT, TAEKUL, JOHNSON F. NORMAN, MASNER LUBOMÍR, K. RAJMOHANA, and SHU-PEI CHEN. "Revision of the world species of the genus Fusicornia Risbec (Hymenoptera: Platygastridae, Scelioninae)." Zootaxa 1966, no. 1 (December 17, 2008): 1–52. http://dx.doi.org/10.11646/zootaxa.1966.1.1.
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The genus Fusicornia Risbec (Hymenoptera: Platygastridae, Scelioninae) is a widespread group in the tropics of the Eastern Hemisphere, distributed from West Africa to Vanuatu. All scelionines are egg parasitoids of arthropods, but the host of Fusicornia is not yet known. The species concepts are revised and a key to world species is presented. The genus is comprised of 19 species, including five known species which are redescribed: F. bambeyi Risbec (sub-Saharan Africa, Madagascar, Yemen); F. indica Mani & Sharma (Australia, India, Philippines, Sri Lanka, Thailand); F. koreica Choi & Kozlov (China, Japan, Korea, Philippines); F. spinosa (Risbec) (sub-Saharan Africa, Saudi Arabia, United Arab Emirates, Yemen); and F. tehrii Mukerjee (Brunei, Indonesia, Japan, Laos, Malaysia, Papua New Guinea, Philippines, Sri Lanka, Taiwan, Thailand). Fusicornia noonae Buhl is considered to be a junior synonym of F. tehrii Mukerjee, n. syn., and F. bambeyi var. inermis Risbec is considered to be a junior synonym of F. spinosa (Risbec), n. syn. The following species are hypothesized and described as new taxa: F. ardis Taekul & Johnson, n. sp. (West Africa, Kenya, Tanzania); F. aulacis Taekul & Johnson, n. sp. (Madagascar); F. collaris Taekul & Johnson, n. sp. (New Guinea); F. crista Taekul & Johnson, n. sp. (Somalia, Tanzania); F. dissita Taekul & Johnson, n. sp. (Vanuatu); F. eos Taekul & Johnson, n. sp. (West Africa, Tanzania, Yemen); F. episcopus Taekul & Johnson, n. sp. (Thailand); F. fax Taekul & Johnson, n. sp. (Papua New Guinea); F. fortuna Taekul & Johnson, n. sp. (Madagascar, Yemen); F. paradisa Taekul & Johnson, n. sp. (sub-Saharan Africa, Madagascar); F. plicata Taekul & Johnson, n. sp. (Sri Lanka); F. skopelos Taekul & Johnson, n. sp. (Madagascar); F. sabrina Taekul & Johnson, n. sp. (Somalia) and F. speculum Taekul & Johnson, n. sp. (Central African Republic, Madagascar, Nigeria, Uganda).
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Stopp, Jacklin Bolton. "A. N. Johnson, Out of Oblivion." American Music 3, no. 2 (1985): 152. http://dx.doi.org/10.2307/3051633.
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Mallin, Robert, and Philip Michels. "In memoriam: N. Peter Johnson, Ph.D." Substance Abuse 20, no. 3 (September 1999): 201–2. http://dx.doi.org/10.1080/08897079909511406.
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Ahmed, F. "Profile of Philip N. Johnson-Laird." Proceedings of the National Academy of Sciences 108, no. 50 (November 7, 2011): 19862–64. http://dx.doi.org/10.1073/pnas.1117174108.
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Batty, Michael. "City 1.0, City 2.0, City n.0, …, City t." Environment and Planning B: Planning and Design 41, no. 1 (February 2014): 1–2. http://dx.doi.org/10.1068/b4101ed.
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Darby, Michael. "New species and records of Ptiliidae (Coleoptera) from Africa in the Collection of the Natural History Museum, London." Entomologist's Monthly Magazine 156, no. 1 (January 31, 2020): 29–47. http://dx.doi.org/10.31184/m00138908.1561.4019.
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Ptiliidae collected in Africa (Ivory Coast, Mozambique, São Tomé, Sierra Leone) 2015–2017 under the auspices of the African Natural History Research Trust and the Natural History Museum, London, are determined to 24 species, 9 of which are new to science: Actidium loma sp. n., Actidium milesi sp. n., Actidium takanoi sp. n., Actidium acutum sp. n., Erro goffi sp. n., Ptilium maputense sp. n., Cissidium aristophanousi Darby (in a separate paper in press), Ptinella clio sp. n., and Ptinella euterpe sp. n.. New records are provided for Ptenidium nitidum Heer, Bambara frosti Dybas, Bambara magnifica Darby, Bambara joannis Vuillet, Ptiliola semitaria Darby, Nephanes marchali (Vuillet), Nephanes plurijugosus Darby, Nephanes titan (Newman), Acrotrichis africana Johnson, Acrotrichis africanoides Johnson, Acrotrichis capensis Johnson, Acrotrichis cephalotes Allibert, Acrotrichis discoloroides Johnson, Acrotrichis setigera Johnson and Acrotrichis tersa Johnson. A table is included listing all known species of Acrotrichis from Africa and the countries where they were found.
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Classens, Michael. "City Farmer: Adventures in Urban Food Growing." UnderCurrents: Journal of Critical Environmental Studies 18 (April 27, 2014): 53–54. http://dx.doi.org/10.25071/2292-4736/38548.
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City Farmer: Adventures in Urban Food Growing.By LORRAINE JOHNSON. D. & M. Publishers Inc., 2010. $19.95Reviewed by Michael ClassensWhile the title of Lorraine Johnson’s most recent book may seem like a disjointed juxtaposition, an ill-conceived utopian fantasy, or both, it is only fleetingly so. Despite the considerable and colliding pathologies of the contemporary food system—adequately summarized in the book— |Johnson forcefully argues that small-scale ‘city farmers’ are the vanguard of an emerging transformation of the contemporary food system. True, in the aggregate, city farming remains more prefigurative than productive, however Johnson’s choice to see the socio-political and ecological benefits of small scale food production is itself an affirmative political maneuver. She’s acutely aware of the formidability of re-inscribing the contemporary food system with more just and sustainable attributes, but also understands that starting in the here-and-now is perhaps the only rational choice in the face of such a challenge. Given that ours is an increasingly urbanized world, the ‘here’ is more often than not an apartment balcony, a neighbourhood park, a building rooftop, a front yard, or a back alley. These are the interstitial—and not inconsequentially, un-commodified—spaces of the urban condition. Johnson’s trick is to reveal the potential in these sometimes derelict, often unassuming spaces, while she concomitantly urges us to re-imagine our own relationship to them. We are all urban farmers, she assures us, and the city is our fertile, however discontiguous, field. Part ‘how to’ manual, part philosophical tract, and part urban adventure travel log, City Farmer reads like a contemporary reorientation guide to our cities-as-farms. And like many good mash-up genres, the strength of this book is in its breadth. Johnson takes us on an extensive urban-ag tour and introduces us to urbanites-cum-farmers tilling everything from yards, balcony containers, and community garden plots, to the less conventional back alley parking spaces, underground bunkers, and even floating barges. Along the way, she punctuates these real-world stops with conceptual and instructional vignettes providing everything from step-by-step briefs on how to start a community garden and how to build a compost bin, to lists of plants that thrive in low-light conditions and instructions detailing how to make wine and jelly from foraged urban edibles. While not the explicit focus of the book, issues of urban policy provide an inevitable backdrop to Johnson’s exploration. Of course policy in the neoliberal city cleaves toward that which best facilitates the circulation and accumulation of capital, tending to favour the spectacle of high-rise condo developments and gentrification over designations of land use for non-commercial, nano-scale farming. Through the realm of urban policy, then, local production of food is brought into conversation with the global forces of commercial real estate development and transnational circuits of capital. While Johnson only sparsely addresses this confrontation head on, the tension flows throughout the book. Her critique of neoliberal urbanism is rarely more incisive on this front than in her treatment of the contradictory posture urban policymakers tend to take in response to urban foraging, guerrilla gardening in neglected urban spaces, and back-yard chicken raising. These are the frontiers of urban food production, propelled in effect (though not necessarily in spirit) by self-reliant individuals. But if self-reliance really is what drives neoliberal policy, then why aren’t governments enabling urban food production? If neoliberal efficiency is predicated on deregulation and less government, then why are city governments so heavily regulating the front and back yards of taxpayers?This is not to suggest that Johnson pursues these lines of argument to their often reactionary ends. She comes nowhere close to defending the frighteningly de rigueur sentiment of contemporary conservatism. On the contrary, she positions the ongoing regulatory resistance to forms of extra-legal urban agriculture as a way to expose the disconnect between the rhetoric and actual practice of neoliberalism. Every time a permit to grow food on a neglected parcel of land is denied, private ownership, individualism, and speculative land investment are reified as the operatics of urban governance. Here Johnson steers us toward a corollary—that urban agriculture can indeed confront the many tendencies of neoliberal capitalism. Transforming the contemporary food system and fundamentally altering the ways our cities are organized is, as Johnson readily admits, hefty weight for a radish, tomato plant, or box of home-grown lettuce to carry. Yet her careful documentation of the dozens of projects, policy initiatives, organizations, and individuals tirelessly working at the intersection of social transformation and urban food growing, somehow stunts the audacity of the symbolic weight she bestows upon the spoils of urban agriculture. If Paul Robbins is right, and manicured lawns (along with their considerable political economy) have played a crucial role in inscribing the modern (sub)urban cultural subject, Johnson reveals the possibility of something altogether different. It’s not just a material transformation of the neglected, marginal, or simply ignored urban sites with the potential to act as micro-farms that Johnson is calling for. Instead she asks that we think about the kinds of social and cultural change farming cities would demand of us, and dares us to consider what kind of subjects we’d become if, those among us that are able to, got our hands a little dirty.Work CitedRobbins, Paul. Lawn People: How Grasses, Weeds, and Chemicals Make Us Who We Are. Philadelphia: Temple University Press, 2007. Print~MICHAEL CLASSENS is a PhD Candidate in the Faculty of Environmental Studies at York University. His work deals mostly with the political ecology of food and agriculture, and figuring out why his Swiss chard keeps dying.
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Habiro, Kazuo, and Gwénaël Massuyeau. "Generalized Johnson homomorphisms for extended N-series." Journal of Algebra 510 (September 2018): 205–58. http://dx.doi.org/10.1016/j.jalgebra.2018.05.031.
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Le Gars, Mathieu, Jerald Sadoff, Mandy Jongeneelen, Dirk Heerwegh, Georgi Shukarev, Carla Truyers, Anne Marit de Groot, et al. "LB7. Ad26.COV2.S-Elicted Neutralizing Activities Against SARS-CoV-2 Variants of Concern in Phase 1/2a and Phase 3 Clinical Trials." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S804—S805. http://dx.doi.org/10.1093/ofid/ofab466.1638.
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Abstract Background In a Phase 3 trial, the Janssen COVID-19 vaccine, Ad26.COV2.S, showed robust efficacy against severe–critical COVID-19 in countries where different SARS-CoV-2 variants were circulating. We evaluated Ad26.COV2.S-elicited antibody neutralizing activity against variants of concern (VOC) B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.617.2 (Delta) in sera from participants in clinical trials following a single dose of Ad26.COV2.S. Methods Neutralizing activities of Ad26.COV2.S (given at a dose level of 5 x 1010 viral particles [vp]) against VOC were assessed by wild-type virus neutralizing (wtVNA) and pseudovirion neutralization (psVNA) assays in sera from participants in Phase 1/2a and Phase 3 clinical trials, respectively. Geometric mean titers (GMTs) were determined at Days 29 and 71 after vaccination. Results In serum samples from Phase 1/2a participants (n = 6), at Day 29 after 1 dose of Ad26.COV2.S, wtVNA titers against VOC were lower than for the original strain (GMT = 573), with GMT = 65, 14, and 15 for Alpha, Beta, and Delta, respectively, representing 8.8-, 40.9-, and 37.7-fold decreases. By Day 71 after vaccination (n = 14), fold differences between the original strain (GMT = 375) and VOC (GMT = 113, 27, and 28) were smaller (3.3-, 13.9-, and 13.4-fold) than at Day 29, suggestive of B-cell maturation (Figure 1). Day 71 titers against the Delta variant were maintained for at least 8 months following a single dose of Ad26.COV2.S (5 x 1010 vp). In serum samples from Phase 3 participants (n = 8), psVNA titers against VOC were lower than the original strain at Day 71 after vaccination, with the lowest titers observed for the Beta variant (3.6-fold decrease vs original strain). Smaller reductions in Nab titers for VOC were observed in the psVNA assay compared to wtVNA. Figure 1. Neutralization of B.1.1.7 (Alpha), B.1.351 (Beta), and B.1.617.2 (Delta) lineages in serum samples from participants who received Ad26.COV2.S. n = 6 samples at Day 29 and n = 14 (n = 14 for Alpha and Beta; n = 6 for Delta, comprising the same 6 participants at Day 29) samples at Day 71 after vaccination with a single dose of Ad26.COV2.S (5 x 10^10 vp dose level) were analyzed in wild-type virus neutralization assays against the SARS-CoV-2 Victoria strain (D614, black dots), the B.1.1.7 (Alpha; green dots) the B.1.351 (Beta; blue dots), and the B.1.617.2 (Delta; purple dots) lineages. Dots represent the IC50 (inhibitory concentration) titers per participant. Geometric mean titers (GMTs) and fold decrease in neutralizing activity between the original Victoria strain and each lineage are shown. Conclusion Ad26.COV2.S-elicited serum neutralizing activity against VOC showed an overall decrease in titers relative to the original strain that was largest for the Beta variant, even though vaccine efficacy against severe–critical COVID-19 was maintained in countries where these variants were circulating versus in countries where they were not circulating. Over time, titers against variants increased, suggesting B-cell affinity maturation leading to increasing coverage of VOC. Disclosures Mathieu Le Gars, n/a, Johnson & Johnson (Employee, Shareholder) Jerald Sadoff, MD, Johnson & Johnson (Employee, Shareholder) Mandy Jongeneelen, n/a, Johnson & Johnson (Employee, Shareholder) Dirk Heerwegh, n/a, Janssen Research and Development (Employee) Georgi Shukarev, MD, Janssen (Employee) Carla Truyers, n/a, Janssen Research and Development (Employee) Anne Marit de Groot, n/a, Johnson & Johnson (Employee) Gert Scheper, n/a, Johnson & Johnson (Employee, Shareholder) Jenny Hendriks, n/a, Johnson & Johnson (Employee, Shareholder) Boerries Brandenburg, n/a, Johnson & Johnson (Employee, Shareholder) Frank Struyf, n/a, Johnson & Johnson (Employee, Shareholder) Johan Van Hoof, n/a, Johnson & Johnson (Employee, Shareholder) Macaya Douoguih, MD, MPH, Janssen (Employee) Hanneke Schuitemaker, PhD, Johnson & Johnson (Employee, Shareholder)
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Darby, Michael. "Studies of Ptiliidae (Coleoptera) in the Spirit Collection of the Natural History Museum, London, 6: New species and records collected by W.C. Block in Kenya and Uganda, 1964–1965." Entomologist's Monthly Magazine 155, no. 4 (October 25, 2019): 239–57. http://dx.doi.org/10.31184/m00138908.1554.3999.
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This paper is based on a collection of Ptiliidae made by W.C. Block in Uganda and Kenya, 1964–1965, and donated to the Natural History Museum, London in 1978. A new genus Nelloptodes gen. n., and nine new species are described and figured: Bambara fragilis sp. n., Bambara lyrae sp. n., Nelloptodes blocki sp. n., Nelloptodes globulus sp. n., Nelloptodes gretae sp. n., Nelloptodes keitai sp. n., Ptinella katyae sp. n., Ptinella mpanga sp. n., Ptinella pygmaea sp. n., and new records and information provided for Pitilium pernix Darby, Bambara frosti Dybas, Bambara gabela Darby, Bambara magnifica Darby, Africoptilium marginatum Johnson, Fenestellidium kakamegaense Grebennikov, Acrotrichis africana Johnson, Acrotrichis alluaudi Johnson and Acrotrichis superba Johnson.
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Cassels, Imogen. "B.S. Johnson's Scaffolding: Form, the City, Cancer, Weeds." Modernist Cultures 16, no. 3 (August 2021): 295–315. http://dx.doi.org/10.3366/mod.2021.0336.
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B.S. Johnson's fiction makes high demands both of its readers and itself. In his statement that ‘telling stories is telling lies’, and desire to ‘tell the truth’, Johnson involves his process in his writing, dismantling the novel form as he also continues to employ it. This committed slipperiness makes him difficult to write about: to pigeonhole him as a po-faced experimentalist or unorthodox social-realist would be a detrimental simplification of his work. A productive consideration of Johnson, then, might look to unusual places: for example, his writerly movements can be re-considered with Lisa Robertson's work on scaffolding in mind. Scaffolding as critical metaphor is both specific enough in its details, and flexible enough in its scope, to manage Johnson's self-effacing difficulty. Johnson's readers, I argue, are required to do their own scaffolding, whether encountering Albert Angelo's gaps, or piecing together The Unfortunates. Seen thus, reading Johnson's novels is a constructive, if messy, act, a collaboration between reader and writer.
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Susan Ali Zroog, Yassin HM Nor- Aldaiem, Mohamed AM Gebralla, and Abdelhakam H. Ali. "Common side effects of Johnson and Johnson COVID-19 vaccine in Ruffaa city, Gezira, Sudan January (2022)." International Journal of Scientific Research Updates 4, no. 1 (August 30, 2022): 155–62. http://dx.doi.org/10.53430/ijsru.2022.4.1.0109.
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Background: The Johnson & Johnson (J&J)/Janssen vaccine was listed for emergency use by WHO on 12 March 2021. The vaccine has been authorized for use in Europe, the United States and other countries. Objectives: This study was conducted to study common side effects of Johnson & Johnson vaccine and the factors associated with adverse effect. Methods: A cross-sectional community based study conducted at Ruffaa city on January (2022), the sample consisted of 361 participants. Data were collected by using questionnaire designed for this study. Data analysis was performed using statistical package for Social Sciences. Results: the study revealed that most of participants (83%) was suffered from local side effects more than halve of them complain from pain in site of injection, Pain & Swelling < 5cm (8%), Pain, and Swelling & Redness More than 3 days (7%). And 76% of participants complain from General side effects 19% of them complain from Fever, (10%) complain from Fever, headache, muscle aches and fatigue. there is statistical relation between pre-existing chronic disease, sex and common side effects of vaccine. The study also revealed that side effects start directly after injection in (63%) of participants. And continue in (87%) from 1-3 days. Study also shows (3%) of participant infected with Covid -19 after vaccination and all of them were hospitalized. Conclusion: The Johnson & Johnson's Janssen COVID-19 Vaccine did not appear to cause any dangerous complications.
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Mittelman, Moshe, Uwe Platzbecker, Boris V. Afanasyev, Sebastian Grosicki, Raymond SM Wong, Achilles Anagnostopoulos, Benjamin Brenner, et al. "Phase 3, Placebo-Controlled, ASPIRE Study (TRC114968) of Eltrombopag (EPAG) Treatment of Thrombocytopenia (TCP) in Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML): Assessment of Clinical Benefit, Safety, and Tolerability." Blood 126, no. 23 (December 3, 2015): 1661. http://dx.doi.org/10.1182/blood.v126.23.1661.1661.
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Abstract Introduction: Thrombocytopenia (TCP) is a serious and life-threatening complication of advanced myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Eltrombopag (EPAG), an oral thrombopoietin-receptor agonist, is approved for treatment of chronic immune thrombocytopenic purpura and severe aplastic anemia. Preclinical studies showed that EPAG has potential antileukemic effects. A phase 1 study in advanced MDS/AML demonstrated an acceptable safety profile at doses up to 300 mg, with no worsening of leukemia, and it also showed a trend towards efficacy. Eltrombopag as monotherapy in MDS/AML has not been studied in a randomized fashion. Methods: In Study TRC114968 (ASPIRE), after 8 weeks of open-label, dose-defining EPAG treatment (Study Part 1), patients with highly advanced MDS or AML were randomized 2:1 to EPAG 100-300 mg or placebo (PBO) once daily for 12 weeks (Part 2), then entered a 6-month, open-label extension (Part 3). Patients were stratified by baseline platelet count (<10 Gi/L vs ≥10 Gi/L), and by MDS vs AML. Eligibility included 10-50% baseline bone marrow blasts and a baseline platelet count of <25 Gi/L. The primary endpoint was improvement in the clinically relevant thrombocytopenic event (CRTE) rate during the 12-week double-blind period. CRTE was a composite of a platelet transfusion requirement, significant bleeding event, or platelet count <10 Gi/L. Part 1 results have been presented previously. Blinded results for patients randomized in Part 2 of the study are presented below. Analyses of results by treatment arm, including those for the primary endpoint of CRTE, are ongoing and will be presented at the meeting. Results: A total of 145 patients were enrolled and randomized. According to WHO criteria, 72 (50%) had MDS and 73 (50%) had AML. See Table 1 for baseline characteristics. The majority of patients (n=91, 63%) were escalated to 300 mg (150 mg for East Asians) once daily. 70 patients (48%) completed the randomized portion of the study, and 58 (40%) entered the open-label extension. Patient disposition is described in Table 2. Out of the 144 treated patients, 97 patients (67%) have died (67 patients in Part 2 and 30 patients in Part 3). The main reasons for withdrawal from the study were adverse events (49 patients, 34%) and progressive disease (39 patients, 27%). The most common adverse events in Part 2 were petechiae, epistaxis, fatigue, pyrexia, and diarrhea. The main serious adverse events in Part 2 were pneumonia, sepsis, and febrile neutropenia. Liver test abnormality occurred in 1 (<1%). The median number of platelet transfusions for both groups was 10. Conclusions: This is the first study to evaluate EPAG as monotherapy in a randomized fashion in patients with advanced MDS or AML and severe thrombocytopenia. Overall safety was as expected for this patient population with no unexpected adverse events. This study provides evidence for the safety of EPAG in this mostly heavily pretreated patient population. An Independent Response Committee (IRC) is currently assessing responses and disease progression centrally by arm, and final data will be presented at the meeting. Funding: This study was sponsored by GlaxoSmithKline; eltrombopag is an asset of Novartis AG as of March 2, 2015. Disclosures Mittelman: Celgene: Research Funding, Speakers Bureau; GlaxoSmithKline: Research Funding; Johnson & Johnson: Research Funding, Speakers Bureau; Novartis Pharmaceuticals Corporation: Research Funding; Roche: Research Funding; Amgen: Research Funding. Off Label Use: Eltrombopag is a once daily oral thrombopoietin receptor agonist approved for treatment of chronic ITP, hepatitis C associated thrombocytopenia, severe aplastic anemia, and pediatric cITP. Data will be presented on use in myeloid malignancies for which eltrombopag is not approved.. Platzbecker:Novartis: Honoraria; Celgene: Honoraria; Amgen, Inc.: Honoraria; GlaxoSmithKline: Honoraria, Research Funding. Wong:Johnson & Johnson: Research Funding; Bristol-Myers Squibb: Research Funding; Merck Sharp & Dohme: Research Funding; Biogen-Idec: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; Roche: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bayer: Consultancy, Research Funding; GlaxoSmithKline: Research Funding. Anagnostopoulos:GlaxoSmithKline: Research Funding. Nagler:Novaratis Pharmaceuticals Corporation: Consultancy, Honoraria, Research Funding. Mannino:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership; GlaxoSmithKline: Employment, Equity Ownership. Stone:Novartis Pharmaceuticals Corporation: Employment; GlaxoSmithKline: Employment, Equity Ownership. Chan:Novartis Pharmaceuticals Corporation: Employment; GlaxoSmithKline: Employment, Equity Ownership. Mostafa Kamel:Novartis Pharmaceuticals Corporation: Employment, Equity Ownership; GlaxoSmithKline: Employment, Equity Ownership. Selleslag:Amgen: Consultancy, Honoraria, Speakers Bureau.
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Brynes, Russell K., Attilio Orazi, Raymond S. M. Wong, Kalpana Bakshi, Christine K. Bailey, and Andres Brainsky. "A Longitudinal Prospective Study Evaluating the Effects of Eltrombopag Treatment On Bone Marrow in Patients with Chronic Immune Thrombocytopenia: Interim Analysis At 1 Year." Blood 120, no. 21 (November 16, 2012): 2195. http://dx.doi.org/10.1182/blood.v120.21.2195.2195.
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Abstract Abstract 2195 Introduction: Eltrombopag (epag), a thrombopoietin receptor agonist (TPO-RA), increases platelet counts in patients with chronic immune thrombocytopenia (cITP). TPO-RAs have been associated with varying degrees of increases in bone marrow reticulin (Brynes 2011; Ghanima 2011). Due to lack of pretreatment evaluations, the incidence and clinical significance of these findings have not been established. Inconsistencies in specimen preparation, staining, and analysis across institutions further confound conclusions. The purpose of this 2-year (y) study (NCT01098487) is to assess for bone marrow fibrosis (reticulin and/or collagen) in patients treated with epag for cITP. Baseline and 1y findings are presented. Methods: Bone marrow biopsies are being collected at baseline (before treatment with epag) and at 1 and 2y of treatment. Specimens are centrally processed and stained for reticulin (silver) and collagen (trichrome) and undergo central independent pathology review of cellularity; megakaryocyte, erythroid, and myeloid quantity and appearance; trabecular bone quality; reticulin grade; and presence of collagen (European Consensus scale-MF; Thiele 2005). Results: Baseline and 1y (10–14 months) data are available for 101 patients. Median age is 42y (18–78); 70 patients are female; 50% are Caucasian/European, 22% are East Asian, and 29% are Central South Asian. Median time since ITP diagnosis is 4.2y (0.2–45.7). All patients had received prior ITP therapy, and 8 patients had received prior TPO-RA treatment (epag [7], romiplostim [1]), the last dose ≥6 months before enrollment. At baseline, 91 patients had reticulin grade 0 (MF-0), 10 MF-1, and 0 MF≥2. At 1y, 59 patients had MF-0, 38 MF-1, 3 MF-2, and 1 MF-3 (Figure). Compared with baseline, there was no change at 1y in MF grade in 61 patients, a decrease by 1 grade in 3, an increase by 1 grade in 35, and an increase in 2 or 3 grades in 1 patient each (Table). Three patients had collagen at 1y (1 patient each with MF-1, MF-2, and MF-3). None of the 4 patients with MF≥2 had adverse events or hematologic abnormalities considered related to impaired bone marrow function, and none withdrew due to bone marrow findings. Among the 8 patients with prior TPO-RA treatment, all had baseline reticulin of MF-0 and none had collagen; at 1y, 6 remained MF-0, 1 was MF-1, and 1 MF-3 (collagen demonstrated). Cellularity was normal in 83% and 80% of patients at baseline and 1y, respectively. Other than normalization of erythroid lineage numbers, no changes occurred in marrow cellular composition. In 3 of 4 patients with MF≥2, cellularity was increased at 1y. Trabecular bone thinning was found at baseline in 28 patients (the majority with prior steroid use) and 51 patients at 1y. Discussion: 10% of patients had MF-1 at baseline. After 1y of treatment, no increase or a mild increase in reticulin was observed in 63% and 35% of patients. No patient with MF≥2 (n=4) had clinical signs or symptoms indicative of bone marrow dysfunction and none withdrew from the study. Results were similar to those reported for EXTEND, an eltrombopag extension study (median treatment duration >2 years; Brynes 2011). Conclusion: These data suggest that treatment with epag is generally not associated with clinically relevant increases in bone marrow reticulin or collagen. The potential association of TPO-RAs and increased bone marrow reticulin needs further study. Disclosures: Brynes: GlaxoSmithKline: Research Funding. Orazi:GlaxoSmithKline: Research Funding. Wong:Roche: Research Funding; MSD: Research Funding; Johnson & Johnson: Research Funding; Bayer: Consultancy, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Biogen-Idec: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Research Funding; GlaxoSmithKline: Research Funding; Bristol-Myers Squibb: Research Funding. Bakshi:GlaxoSmithKline: Employment, Equity Ownership. Bailey:GlaxoSmithKline: Employment, Equity Ownership. Brainsky:GlaxoSmithKline: Employment, Equity Ownership, Patents & Royalties.
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KITLV, Redactie. "Book Reviews." Bijdragen tot de taal-, land- en volkenkunde / Journal of the Humanities and Social Sciences of Southeast Asia 162, no. 4 (2008): 523–94. http://dx.doi.org/10.1163/22134379-90003665.
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I Wayan Arka, Malcolm Ross (eds); The many faces of Austronesian voice systems; Some new empirical studies (René van den Berg) H.W. Dick; Surabaya, city of work; A socioeconomic history, 1900-2000 (Peter Boomgaard) Josiane Cauquelin; The aborigines of Taiwan: the Puyuma; From headhunting to the modern world. (Wen-Teh Chen) Mark Turner, Owen Podger (with Maria Sumardjono and Wayan K. Tirthayasa); Decentralisation in Indonesia; Redesigning the state (Dorian Fougères) Jérôme Samuel; Modernisation lexicale et politique terminologique; Le cas de l’Indonésien (Arndt Graf) Nicholas J. White; British business in post-colonial Malaysia, 1957-70: neo-colonialism or disengagement? (Karl Hack) Chin Peng; Alias Chin Peng; My side of history; As told to Ian Ward and Norma Miraflor (Russell Jones) C.C. Chin, Karl Hack (eds); Dialogues with Chin Peng; New light on the Malayan Emergency (Russell Jones) Saw Swee-Hock; Population policies and programmes in Singapore (Santo Koesoebjono) Domenyk Eades; A grammar of Gayo; A language of Aceh, Sumatra (Yuri A. Lander) Derek Johnson, Mark Valencia (eds); Piracy in Southeast Asia; Status, issues, and responses (Carolyn Liss) Niclas Burenhult; A grammar of Jahai (James A. Matisoff) Ann R. Kinney, Marijke J. Klokke, Lydia Kieven (photographs by Rio Helmi); Worshiping Siva and Buddha; The temple art of East Java (Dick van der Meij) Ruben Stoel; Focus in Manado Malay; Grammar, particles, and intonation (Don van Minde) Pamela J. Stewart, Andrew Strathern (eds); Expressive genres and historical change; Indonesia, Papua New Guinea and Taiwan. (Dianne van Oosterhout) Johszua Robert Mansoben; Sistem politik tradisional di Irian Jaya, Indonesia; Studi perbandingan (Anton Ploeg) Timothy B. Barnard (ed.); Contesting Malayness; Malay identities across boundaries (Nathan Porath) Joel Bradshaw, Francisc Czobor (eds); Otto Dempwolff’s grammar of the Jabêm language in New Guinea (Ger Reesink) Jon Fraenkel; The manipulation of custom; From uprising to intervention in the Solomon Islands (Jaap Timmer) Clive Moore; Happy isles in crisis; The historical causes for a failing state in Solomon Islands, 1998-2004 (Jaap Timmer) Peter Burns; The Leiden legacy; Concepts of law in Indonesia (Bryan S. Turner) Terry Crowley; Bislama reference grammar (Kees Versteegh) REVIEW ESSAY Matthew Isaac Cohen; Transnational and postcolonial gamelan Lisa Gold; Music in Bali Margaret J. Kartomi; The Gamelan Digul and the prison camp musician who built it; An Australian link with the Indonesian revolution Marc Perlman; Unplayed melodies; Javanese gamelan and the genesis of music theory Ted Solís (ed.); Performing ethnomusicology; Teaching and representation in world music ensembles Henry Spiller; Gamelan; The traditional sounds of Indonesia Andrew N. Weintraub; Power plays; Wayang golek theater of West Java REVIEW ESSAY Victor T. King; People and nature in Borneo Tim Bending; Penan histories; Contentious narratives in upriver Sarawak Rajindra K. Puri; Deadly dances in the Bornean rainforest; Hunting knowledge of the Penan Benalui, 2005 Reed L. Wadley (ed.); Histories of the Borneo environment; Economic, political and social dimensions of change and continuity In: Bijdragen tot de Taal-, Land- en Volkenkunde no. 162 (2006), no: 4, Leiden
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Vernezze, Peter J. "Socrates and the Immoralists, by Curtis N. Johnson." Ancient Philosophy 27, no. 2 (2007): 424–25. http://dx.doi.org/10.5840/ancientphil200727214.
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Siebert, S., L. Coates, G. Schett, S. P. Raychaudhuri, W. Chen, S. Gao, S. D. Chakravarty, et al. "POS0074 IMMUNOLOGICAL DIFFERENCES BETWEEN PsA PATIENTS WHO ARE TUMOR NECROSIS FACTOR INHIBITOR-NAIVE AND WHO HAVE INADEQUATE RESPONSE TO TUMOR NECROSIS FACTOR INHIBITORS." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 254.2–255. http://dx.doi.org/10.1136/annrheumdis-2022-eular.892.
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BackgroundA better understanding of the immunological differences between psoriatic arthritis (PsA) patients (pts) who are tumor necrosis factor inhibitor (TNFi)-naïve & who have inadequate response to TNFi (TNFi-IR) may guide treatment choices. In DISCOVER-1, benefit of the IL-23p19 subunit inhibitor guselkumab (GUS) every-four-weeks (Q4W) & Q8W vs placebo (PBO) in improving PsA signs & symptoms was seen in adults with active PsA.1 The Ph3b COSMOS study of GUS Q8W vs PBO in TNFi-IR PsA pts corroborated these findings.2ObjectivesAssess baseline (BL) molecular differences between TNFi-naïve & -IR PsA pts & investigate GUS pharmacodynamic (PD) effect on cytokine expression over time in these cohorts.MethodsSerum samples collected from consenting biomarker substudy pts in DISCOVER-11 (TNFi-naïve [n=101] & -IR [n=17]), DISCOVER-23 (TNFi-naïve [n=150]), & COSMOS2 (TNFi-IR [n=76]) were analyzed for selected serum cytokine levels. TNFi-IR pts in this post-hoc analysis had active PsA & discontinued 1-2 TNFi due to inadequate efficacy; these pts required a TNFi-specific washout period prior to starting GUS. PD effect of GUS Q8W on cytokine levels was assessed. Differential BL cytokine expression, associations between BL cytokine levels & clinical response (Psoriasis [PsO] Area & Severity Index 75% improvement from BL [PASI75] & American College of Rheumatology 20% improvement [ACR20]), & GUS effect on cytokine levels were analyzed with a General linear model & Spearman linear regression.ResultsBL pt demographics, disease characteristics, & conventional synthetic disease-modifying antirheumatic drug (csDMARD) use were comparable between TNFi-naïve (DISCOVER-1 & -2, N=251) & -IR (DISCOVER-1 & COSMOS, N=93) pts, with differences in mean PASI score (8.9 v 12.5), swollen joint count (SJC) (11.7 v 10.3), PsA duration (5.8 v 9.8 yrs), & PsO duration (16.7 v 20.4 yrs; Table 1). BL serum IL-22 & TNFα levels for pooled treatment groups were higher in TNFi-IR than -naïve pts (p<0.05). At W24, GUS reduced IL-22, IL-17A/F, IL-6, C-reactive protein (CRP), & serum amyloid A protein to similar levels in both cohorts (p<0.05; Figure 1). W24 PASI75 responders had higher BL IL-17F levels with GUS in both cohorts (p<0.05) & higher IL-22 levels in TNFi-IR pts only (p<0.05). A trend of upregulated BL IL-22 expression in W24 ACR20 responders was seen for TNFi-IR pts with GUS (p=0.07).Table 1.BL demographics, disease characteristics, & drug use in TNFi-naïve & -IR cohorts with available cytokine data in DISCOVER-1&2 & COSMOS.*TNFi-naïve (N=251)TNFi-IR (N=93)Age [yrs]47.2 (11.3)48.5 (11.1)Female, n (%)132 (52.6)46 (49.5)Body mass index [kg/m2]29.6 (6.1)30.3 (6.4)Median (range) CRP [mg/dL]0.9 (0.0-12.9)1.0 (0.0-13.2)Log2 IL-22 / TNFα [pg/mL]2.0 (1.4) / 1.1 (0.6)2.5 (1.5) / 1.9 (1.2)Log2 IL-17A / F [pg/mL]-0.4 (1.5) / 1.7 (1.5)-0.1 (1.7) / 2.0 (1.6)SJC [0-66]11.7 (7.1)10.3 (8.3)TJC [0-68]20.3 (13.1)20.6 (14.2)PsA duration [yrs]5.8 (5.9)9.8 (8.2)PsO duration [yrs]16.7 (12.8)20.4 (12.0)PsO Body surface area (%)14.8 (18.6)19.1 (21.3)Investigator’s Global Assessment score [0-4]2.3 (0.9)2.3 (1.0)PASI score [0-72]8.9 (10.6)12.5 (12.0)Enthesitis [Y], n (%)160 (63.7)58 (62.4)csDMARD use [Y], n (%)164 (65.3)62 (66.7)Corticosteroid use (Y), n (%)45 (17.9)19 (20.4)Methotrexate use [Y], n (%)136 (54.2)54 (58.1)Data are mean (SD) unless otherwise noted. *Pts with serum CRP level ≥0.3 mg/dL, SJC ≥3, & TJC ≥3 (to mimic D1 inclusion criteria1). TJC= tender joint countConclusionElevated BL IL-22 expression & association between BL IL-22 levels & W24 PASI75 response, & a W24 trend for an association between upregulated BL IL-22 & ACR20 response, in TNFi-IR pts seen in this exploratory analysis may suggest increased involvement of the IL-23 pathway in TNFi-IR pts. GUS showed comparable & significant PD effects for TNFi-naïve & -IR pts, consistent with observed clinical responses.References[1]Deodhar A, et al. Lancet. 2020;395:1115-25.[2]Coates LC, et al. Ann Rheum Dis. 2021;80:140-1.[3]Mease P, et al. Lancet. 2020;395:1126-36.Disclosure of InterestsStefan Siebert Speakers bureau: AbbVie, Biogen, GSK, Janssen, Novartis, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, GSK, Janssen, Novartis, and UCB, Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Georg Schett Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, and UCB, Siba P Raychaudhuri Speakers bureau: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Consultant of: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma, and UCB, Warner Chen Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), Sheng Gao Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson & Johnson), May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Frederic Lavie Shareholder of: Johnson & Johnson, Employee of: Janssen Pharmaceutical Companies of Johnson & Johnson, Elke Theander Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson & Johnson), Marlies Neuhold Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC (a wholly owned subsidiary of Johnson & Johnson), Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), Xie L Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC (a wholly owned subsidiary of Johnson & Johnson), Proton Rahman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, and UCB, Grant/research support from: Janssen and Novartis, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Consultant of: AbbVie, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GSK, Inmagene, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Atul Deodhar Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GSK, Janssen, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, and UCB
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Gifkins, Dina, Megan McAuliffe, Amy Matcho, Jane Porter, Scott Chavers, Maria Ponsillo, Jay King, Avinash Desai, Andrew Cakana, and Dixie-Lee Esseltine. "Second Malignancies Among Elderly Multiple Myeloma Patients Exposed to Bortezomib and Other Treatments: An Analysis of the US SEER-Medicare Linked Database,." Blood 118, no. 21 (November 18, 2011): 3972. http://dx.doi.org/10.1182/blood.v118.21.3972.3972.
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Abstract Abstract 3972 Second hematologic malignancies have been found to occur at a higher rate among multiple myeloma patients compared to the general population. Although alkylating therapy has been suggested to play a role, the underlying causes remain largely unclear. Increased survival benefit has been documented with the introduction of novel agents over the past decade, and, as noted in other cancers, there may also be a higher occurrence of second malignancies in the era of novel therapies. Recently, data from Phase III studies suggest that patients treated with lenalidomide with prior exposure to melphalan may have an increased risk compared to placebo. However, the contribution of other specific agents has not been well characterized. Evaluation of second malignancies in clinical trial and product safety data for bortezomib has not revealed an increased incidence in bortezomib-treated patients. Additionally, our follow-up study of the VISTA clinical trial participants after 5 years showed no elevation in risk (San Miguel, et al. ASH 2011). To expand our current knowledge, we are conducting a population-based study using the NCI SEER-Medicare database (NCI SEER cancer registry linked with diagnostic and treatment claims data of Medicare beneficiaries) to evaluate bortezomib and other standard treatment exposures in relation to second malignancies subsequent to multiple myeloma. Using the NCI SEER-Medicare database, we identified all multiple myeloma patients with their first diagnosis between 1 Jan 2000 and 31 Dec 2007 aged 66 years or older. Exposure to chemotherapy was identified via Medicare claims, and second malignancies, defined as invasive cancers whose onset was after bortezomib-based therapy and occurring at least 2 months after the initial multiple myeloma diagnosis, were identified from the SEER registries. We identified the number of second malignancies among elderly patients with multiple myeloma and following bortezomib exposure; expanded multivariate analyses, adjusted for exposures, will be presented at the meeting. A total of 9,377 multiple myeloma patients were identified (median age 76 years; 50% males). During the study period, 2,285 (21%) patients had any documented exposure to bortezomib (with or without other treatments). Patients with bortezomib exposure had a median age of 73 years, and 55% were male. Among these 2,285 patients with bortezomib exposure, 33 patients (1.4%) developed a second malignancy (4 [0.2%] hematologic and 29 [1.3%] solid tumors) during the study period after their first documented bortezomib exposure. Hematologic tumors were non-Hodgkin lymphoma (n=3) and acute myeloid leukemia (n=1). Solid tumors were prostate (n=4), bladder (n=4), lung and bronchus (n=3), colon (excluding rectum) (n=3), breast (n=3), and other (n=12). Among the 7,092 multiple myeloma patients with no documented exposure to bortezomib, 320 (4.5%) developed a second malignancy (55 [0.8%] hematologic and 265 [3.7%] solid tumors) during the study period. Hematologic tumors were non-Hodgkin lymphoma (n=16), acute myeloid leukemia (n=7), chronic lymphocytic leukemia (n=2), acute lymphocytic leukemia (n=1), chronic myeloid leukemia (n=1), Hodgkin lymphoma (n=1), and other (n=27). Solid tumors were lung and bronchus (n=46), prostate (n=38), colon (excluding rectum) (n=33), melanoma (n=23), bladder (n=21), breast (n=17), and other (n=87). Based on more than 9,000 elderly multiple myeloma patients, we found a lower prevalence of second malignancies among persons exposed to bortezomib compared to those with no documented bortezomib exposure in our unadjusted analysis. To account for survival and adjust for other exposures, expanded analyses will be presented at the meeting, including standardized incidence ratios and calculations of absolute excess risk among patients exposed to bortezomib and other standard treatments compared to the general SEER population, cumulative incidence of second malignancy for each treatment group adjusting for death as a competing risk, and multivariate analyses to assess risk while adjusting for prior and concomitant treatments and other risk factors. Disclosures: Gifkins: Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. McAuliffe:Millennium Pharmaceuticals, Inc.: Employment. Matcho:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Porter:Millennium Pharmaceuticals, Inc.: Employment. Chavers:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Ponsillo:Millennium Pharmaceuticals, Inc.: Employment. King:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Desai:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Cakana:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Esseltine:Millennium Pharmaceuticals, Inc.: Employment; Johnson & Johnson: Equity Ownership.
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Falk, Rodney H., Morie A. Gertz, Merrill D. Benson, Gustavo Buchele, Michela Brambatti, Sotirios Tsimikas, Nicholas J. Viney, et al. "Rationale and Design of a Phase 3 Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)." Blood 134, Supplement_1 (November 13, 2019): 5764. http://dx.doi.org/10.1182/blood-2019-129269.
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Background: Transthyretin amyloidosis cardiomyopathy (ATTR-CM) is a life-threatening, irreversible condition, which can lead to heart failure (HF) and, ultimately, heart transplant or death. Despite the recent approval in United States of a TTR stabilizer (VYNDAQEL®-tafamidis meglumine;VYNDAMAX™-tafamidis) for the treatment of ATTR-CM, disease progression still occurs. This study aims to determine if treatment with AKCEA-TTR-LRx (ION-682884), an antisense oligonucleotide (ASO), is safe and superior to placebo in reducing the risk of cardiovascular (CV) death or CV clinical events in patients with hereditary (hATTR-CM) or wild-type ATTR-CM (wtATTR-CM). Study Design and Methods: AKCEA-TTR-LRx (ION-682884) is a follow-on compound that incorporates the Ligand-Conjugated Antisense (LICA) technology; in this case, a triantennary N-acetyl galactosamine (GalNAc) moiety which targets the asialoglycoprotein receptors (ASGPR) expressed abundantly on the hepatocyte cell surface. In comparison to inotersen, its parent compound, ION-682884 requires a lower dose and frequency of administration (27-fold smaller; 45mg SC Q4W) to achieve a similar reduction in ATTR, providing greater patient convenience. ION-682884-CS2 (EudraCT No: 2019-002835-27) is a Phase 3 global, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of AKCEA-TTR-LRx (ION-682884) in hATTR-CM or wtATTR-CM patients receiving available background standard of care (SoC) therapy. Approximately 750 patients with a history of HF due to ATTR-CM will be randomized 1:1 to receive AKCEA-TTR-LRx (ION-682884) or placebo administered by subcutaneous injection once every 4 weeks. The main inclusion criteria include confirmed diagnosis of ATTR-CM by tissue biopsy or positive PYP/DPD scan, end-diastolic interventricular septum thickness of >12mm, NT-proBNP >600 pg/mL, NYHA class I-III and 6-minute walk distance (6MWD) >150 m. The main exclusion criteria include estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2, platelet count below the low limit of normality and urine protein/creatinine ratio (UPCR) ≥ 1000 mg/g. Patients are allowed to concomitantly receive tafamidis/tafamidis meglumine as SoC for ATTR-CM, if locally approved and available, per physician's discretion. The study consists of a 120-week Treatment Period and a 20-week Post-Treatment Evaluation Period. During each study visit, subjects will undergo laboratory tests, cardiac assessments (echocardiography), and functional evaluations. Patient-reported outcomes (PRO) will also be collected. Primary efficacy endpoint is the composite of CV mortality and frequency of CV clinical events (HF-related urgent visits requiring administration of IV diuretics and/or CV-related hospitalizations) at Week 120 study visit, analyzed by the Finkelstein-Shoenfeld method. This test is based on the principle of each patient in the study being compared with every other patient in a pairwise manner in hierarchical fashion. Secondary endpoints include the change from baseline in the 6MWD, Kansas City Cardiomyopathy Questionnaire score, rate of CV mortality, CV clinical events, and all-cause of mortality at Week 120. Additional exploratory endpoints include a change from baseline in cardiac imaging parameters, renal function, biomarkers, and PROs questionnaires and disease scores. An interim analysis on change from baseline in 6MWD is also planned at Week 60. All deaths and CV clinical events will be adjudicated by an independent, blinded Clinical Adjudication Committee, using predefined endpoint criteria. Conclusions: Despite recent advances, there is still a need for more efficacious, safe and convenient treatment options for ATTR-CM. The ION-682884-CS2 is a large Phase 3 trial designed to evaluate the clinical efficacy and safety of AKCEA-TTR-LRx (ION-682884) compared to placebo for the treatment of ATTR-CM. Figure Disclosures Falk: Ionis Pharmaceuticals: Consultancy. Gertz:Ionis/Akcea: Consultancy; Alnylam: Consultancy; Proclara: Membership on an entity's Board of Directors or advisory committees; Prothena Biosciences Inc: Consultancy; Celgene: Consultancy; Janssen: Consultancy; Spectrum: Consultancy, Research Funding; Annexon: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Abbvie: Other: personal fees for Data Safety Monitoring board; Research to Practice: Consultancy; Teva: Speakers Bureau; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; i3Health: Other: Development of educational programs and materials; Springer Publishing: Patents & Royalties; Amyloidosis Foundation: Research Funding; International Waldenstrom Foundation: Research Funding. Benson:Ionis Pharmaceuticals: Research Funding. Buchele:Ionis Pharmaceuticals: Employment. Brambatti:Ionis Pharmaceuticals: Employment. Tsimikas:Ionis Pharmaceuticals: Employment. Viney:Ionis Pharmaceuticals: Employment. Tai:Ionis Pharmaceuticals: Employment. Monteiro:Ionis Pharmaceuticals: Employment. Yang:Ionis Pharmaceuticals: Employment. O'Dea:Akcea Therapeutics: Employment. Karwatowska-Prokopczuk:Akcea Therapeutics: Employment. Schneider:Ionis Pharmaceuticals: Employment. Geary:Ionis Pharmaceuticals: Employment. Monia:Ionis Pharmaceuticals: Employment.
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Baraliakos, X., M. Østergaard, R. B. M. Landewé, W. Barchuk, K. Liu, C. Tasset, L. Gilles, T. Hendrikx, R. Besuyen, and W. P. Maksymowych. "OP0141 EFFECTS OF FILGOTINIB ON SPINAL LESIONS IN ANKYLOSING SPONDYLITIS: MAGNETIC RESONANCE IMAGING DATA FROM THE TORTUGA TRIAL." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 83–84. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1797.
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Background:The oral Janus kinase 1 preferential inhibitor filgotinib (FIL) significantly improved Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) inflammation scores (bone marrow oedema) in the spine and sacroiliac joints vs placebo (PBO) in the Phase 2 TORTUGA trial (NCT03117270) in patients with active ankylosing spondylitis (AS).1Objectives:This post-hoc analysis evaluated the effects of FIL on Canada-Denmark (CANDEN) MRI measures of spinal inflammation and structural lesions in patients from the TORTUGA trial.Methods:TORTUGA was a PBO-controlled, multicentre, double-blind, randomised trial. Patients with active AS (as per modified New York classification criteria, with sacroiliitis confirmed by central reading) were treated with FIL 200 mg (n=58) or PBO (n=58) once daily for 12 weeks. MRI of the total spine was conducted at baseline and at treatment end. Scans were re-evaluated post-hoc by 2 independent experts (blinded to time point and assigned treatment) using the CANDEN method;2 inter-reader discrepancies were resolved by an independent adjudicator. Observed changes from baseline were evaluated using analysis of covariance, with factors for treatment, baseline value, and randomisation stratification by prior tumour necrosis factor inhibitor use. Least-squares (LS) mean changes from baseline and between-group differences with 95% confidence intervals (CI) were calculated; P values are nominal.Results:MRI scans from 88 patients (47 FIL, 41 PBO) with an evaluable scan at baseline and Week 12 (or early termination) were re-evaluated. Baseline characteristics were generally similar between patients with/without an MRI scan. Of those with MRI scans, mean total spine inflammation score (which ranges from 0–614) was higher, and mean ankylosis score (which ranges from 0–460) was lower, in the FIL vs PBO group at baseline. Total spine inflammation scores decreased from baseline with FIL but not with PBO (Figure and Table; P=0.0003 for between-group difference). Cumulative probability plots favoured FIL over PBO for change from baseline in subregion inflammation scores, including posterolateral elements (i.e. sum of lesions in ribs, transverse processes, spinous processes, soft tissue inflammation, and postero-lateral vertebral body), facet joint, and vertebral body. Total spine fat lesion scores numerically increased from baseline in the FIL but not PBO group (P=0.0878 for between-group difference; Table). There were no significant differences between groups for changes in erosion (P=0.1956) or ankylosis (P=0.3888) scores (Table).Table 1.Change from baseline at Week 12 in CANDEN total spine inflammation, total spine fat, total spine bone erosion, and ankylosis scoresTreatment groupnSample mean (SE)LS mean (SE)95% CI of treatment meanLS mean of group difference (SE)95% CI of group differenceBetween-group P valueTotal spine inflammation scoreFilgotinib47–4.98 (0.96)–4.40 (1.13)–6.65, –2.15–4.49 (1.21)–6.85, –2.120.0003Placebo410.29 (0.78)0.09 (1.13)–2.17, 2.34Total spine fat scoreFilgotinib471.01 (0.62)1.09 (0.66)–0.22, 2.401.18 (0.69)–0.18, 2.550.0878Placebo41–0.25 (0.19)–0.09 (0.66)–1.40, 1.21Total spine bone erosion scoreFilgotinib470.01 (0.02)0.07 (0.03)0.00, 0.140.05 (0.04)–0.02, 0.120.1956Placebo41–0.02 (0.03)0.02 (0.03)–0.04, 0.09Total ankylosis scoreFilgotinib470.30 (0.29)0.23 (0.31)–0.40, 0.850.28 (0.34)–0.37, 0.940.3888Placebo41–0.01 (0.08)–0.06 (0.31)–0.68, 0.56SE, standard errorConclusion:This is the first PBO-controlled trial to demonstrate a decrease in inflammatory activity with FIL, not only in the spinal vertebrae but also in the postero-lateral elements of the spine and facet joints. As expected in a 12-week study period, no changes in erosion or ankylosis were seen, while fat lesions showed a tendency to increase with FIL. Larger trials are needed to confirm these results.References:[1]van der Heijde D, et al. Lancet 2018;392:2378–87.[2]Krabbe S, et al. RMD Open 2019;5:e001057.Acknowledgements:The TORTUGA trial was sponsored by Galapagos NV (Mechelen, Belgium) and co-funded by Galapagos NV and Gilead Sciences, Inc. (Foster City, CA, USA). Medical writing support was provided by Debbie Sherwood BSc, CMPP (Aspire Scientific Ltd, Bollington, UK), and funded by Galapagos NV.Disclosure of Interests:Xenofon Baraliakos Consultant of: AbbVie, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Hexal, Janssen, MSD, Novartis, Pfizer, Sandoz and UCB, Grant/research support from: AbbVie, Celgene, Novartis and UCB, Mikkel Østergaard Speakers bureau: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Orion, Pfizer, Roche, Sandoz, Sanofi and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi and UCB, Grant/research support from: AbbVie, Bristol Myers Squibb, Celgene, Merck and Novartis, Robert B.M. Landewé Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Janssen (formerly Centocor), Merck, Pfizer, Roche, Schering and UCB, Consultant of: AbbVie, Ablynx, Amgen, AstraZeneca, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Pfizer, Roche, Schering, TiGenix and UCB, Grant/research support from: AbbVie, Amgen, Janssen (formerly Centocor), Novartis, Pfizer, Roche, Schering and UCB, Employee of: Director of Rheumatology Consultancy BV, William Barchuk Shareholder of: Gilead Sciences, Inc., Employee of: Currently employee of Gilead Sciences, Inc.; and former employee of AbbVie, Eli Lilly and Johnson & Johnson, Ke Liu Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Chantal Tasset Shareholder of: Galapagos, Employee of: Galapagos, Leen Gilles Employee of: Galapagos, Thijs Hendrikx Shareholder of: Galapagos, Employee of: Galapagos, Robin Besuyen Shareholder of: Galapagos, Employee of: Galapagos, Walter P Maksymowych Speakers bureau: AbbVie, Janssen, Novartis, Pfizer and UCB, Consultant of: AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Novartis, Pfizer and UCB, Employee of: Chief Medical Officer of CARE Arthritis Limited
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Otoukesh, Salman, Hany Elmariah, Dongyun Yang, Sally Mokhtari, Madiha Siraj, Haris Ali, Krishnakar Mogili, et al. "Clinical Impact of Cytokine Release Syndrome on Outcomes of Peripheral Blood Stem Cell Haploidentical Hematopoietic Cell Transplantation with Post-Transplant Cyclophosphamide." Blood 136, Supplement 1 (November 5, 2020): 10–11. http://dx.doi.org/10.1182/blood-2020-143166.
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Peripheral blood stem cell (PBSC) as a graft source compared to bone marrow has been reported to result in lower risk of relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) with use of post-transplant cyclophosphamide (PTCy) as a graft-versus-host-disease (GvHD) prophylaxis. However, cytokine release syndrome (CRS) is a common complication of this platform that can affect the outcomes of patients after PBSC haplo-HCT. CRS occurs due to rapid activation and proliferation of alloreactive donor T cells resulting in the elevated secretion of inflammatory cytokines. In this study, we sought to examine the risk factors for CRS and the effect of CRS severity on outcomes of PBSC haplo-HCT. We identified total of 271 consecutive patients with hematological malignancies who received their first PBSC haplo-HCT with PTCy-based GVHD prophylaxis at City of Hope (n=157) or Moffitt (n=114) Cancer Centers between 2014 and 2019. The median patient age at HCT was 54 years (INQ range, 37-64) for the entire cohort and 48% of the patients had HCT-CI ³3. Close to 70% of the study cohort had acute leukemia and 33% of all patients had high/very high-risk disease risk index. Myeloablative conditioning was used in 52% of the cases and 81% of all HCT recipients were CMV seropositive. The median donor age at HCT was 33 years (INQ range, 26-43). The HLA -A, -B, -C, -DRB1, -DQB1, or -DPB1 mismatch between the recipient and the donor in the GVH direction was 5/10 in 51%, 4/10 in 29% and £3/10 in 20% of cases. Offspring donors were used in 54% of the patients, sibling donors in 35%, and parent/other relative donors in 11%. Female donors to male recipients were used in only 22% of patients. The median infused CD34 dose was 5.25 x106 cells/kg (range, 2.3-22.4x106) and the CD3 dose was 2.48x108 cells/kg (range, 0.002-8.88 x108). CRS of any grade by ASTCT criteria was observed in 92% of study patients within first 7 days of HCT: 54% had grade 1, 39% grade 2, and 5.2% grade 3-4. Infused cell doses of CD34 >5x106 cells/kg and of CD3 >2.5x108 cells/kg had no significant effect on grade 3-4 CRS. On multivariable analysis, the use of reduced-intensity conditioning (RIC) was associated with increased grade 2-4 CRS (HR = 1.6, 95% CI: 1.11.-2.33, p=0.01) and grade 3-4 CRS (HR = 14.7, 95% CI: 1.97-109.5, p=0.009) compared with the myeloablative conditioning. Donor 5/10 HLA-mismatch was also associated with increased grade 2-4 CRS (HR = 1.5, 95% CI: 1.05-2.18; p=0.03) and grade 3-4 CRS (HR = 3.50, 95% CI: 1.00-12.32; p=0.05) compared with £4/10 HLA-mismatch. Non-relapse mortality (NRM) at day 100, and 1-year overall survival (OS) by CRS severity is shown in Figure. Comparing with the grade 0-1 CRS in multivariable analysis (Table), increase in CRS severity was associated with lower probability of neutrophil engraftment (HR = 0.9 for grade 2 and HR = 0.4 for grade 3-4; p=0.03). Increased CRS severity as compared to the grade 0-1 was also predictive of higher risks of NRM (HR = 1.6, 95% CI: 0.95-2.79 for grade 2 and HR = 6.6, 95% CI: 3.12-13.78 for grade 3-4; p<0.001), lower disease-free survival (DFS; HR = 1.3 for grade 2 and HR = 4.5 for grade 3-4; p<0.001) and lower OS (HR = 1.2 for grade 2 and HR = 4.1 for grade 3-4; p<0.001) after HCT. We observed no association between CRS severity and risk of relapse or the incidence and severity of acute GvHD after transplant. We conclude that CRS is a common complication after PB haplo-HCT/PTCy. CRS severity is associated with post-HCT outcomes with grade 3-4 CRS associated with the highest risk of NRM and overall mortality after HCT. Infused CD34 or CD3 cell doses effect on CRS is unclear. RIC and higher degree of HLA-mismatch are predictive of higher-grade CRS. Identification of modifiable risk factors can help to mitigate the risk for serious CRS and subsequent mortality after PB haplo-HCT/PTCy. Figure 1 Disclosures Nishihori: Karyopharm: Other: Research support to institution; Novartis: Other: Research support to institution. Pidala:CTI Biopharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Research Funding; Takeda: Research Funding; Janssen: Research Funding; Johnson and Johnson: Research Funding; Pharmacyclics: Research Funding; Abbvie: Research Funding; BMS: Research Funding; Syndax: Consultancy, Membership on an entity's Board of Directors or advisory committees. Nakamura:Merck: Other: advisory board meeting; Alexion: Other: Support on a meeting presentation; Kyowa-Kirin: Other: Support on a meeting presentation; Celgene: Other: Support on seminar; Magenta Therapeutics: Other: Advisory board meeting; Viracor: Consultancy; Kadmon Corporation: Other: Advisory board meeting; NapaJen Pharma: Consultancy. Al Malki:Rigel Pharma: Consultancy; Jazz Pharmacuticals, Inc: Consultancy; Neximmune: Consultancy. Bejanyan:Kiadis Pharma: Membership on an entity's Board of Directors or advisory committees.
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SKEVINGTON, JEFFREY H. "Revision of Nearctic Nephrocerus Zetterstedt (Diptera: Pipunculidae)." Zootaxa 977, no. 1 (May 13, 2005): 1. http://dx.doi.org/10.11646/zootaxa.977.1.1.
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The Nearctic species of Nephrocerus Zetterstedt, 1838 are revised and include two described species, N. daeckei Johnson, 1903 and N. slossonae Johnson, 1915, and four new species: N. acanthostylus spec. nov., N. atrapilus spec. nov., N. corpulentus spec. nov. and N. woodi spec. nov. A key to species is provided and diagnostic characters, including male and female genitalia, are illustrated. Nephrocerus is recorded for the Neotropical Region for the first time.
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Johnson, Lorin. "Preface." Experiment 20, no. 1 (October 27, 2014): 17–30. http://dx.doi.org/10.1163/2211730x-12341257.
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This current volume of Experiment, Volume 20, entitled “Kinetic Los Angeles: Russian Émigrés in the City of Self-Transformation” (Guest Editor, Lorin Johnson) is dedicated to the contributions of Russian artists who lived and worked in Los Angeles in the fields of dance performance, visual arts, and film, exploring how the city was influenced by their presence as well as the reasons that drew them to Southern California. While many of the essays focus on the émigré community that gathered in Los Angeles during the 1930s-1940s, the investigation of “Russianness” in the city is not confined to those decades. Each essay in this volume is accompanied by photographs and illustrations which help to tell this story, many of which are previously unpublished and recently discovered in private collections and archives in the U.S. and abroad. Contributors include: Kenneth Archer, John Bowlt, Donald Bradburn, Elizabeth Durst, Lynn Garafola, Karen Goodman, Millicent Hodson, Lorin Johnson (Guest Editor), Mark Konecny, Debra Levine and Oleg Minin.
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Rd. Sekar Putri Defiyanti, Sali Setiatin, and Aris Susanto. "Analisis Trend Dan Grafik Barber Johnson Pada Efisiensi Tempat Tidur Di Rumah Sakit X Kota Bandung." Jurnal Ilmiah Perekam dan Informasi Kesehatan Imelda (JIPIKI) 6, no. 2 (August 26, 2021): 119–30. http://dx.doi.org/10.52943/jipiki.v6i2.576.
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Trend analysis is a statistical analysis method used for planning and evaluating efforts to minimize risk for the better. The purpose of this study was to analyze trends and barber johnson charts on the efficiency of bed use at X Hospital, Bandung City. This type of research is a qualitative method with a descriptive approach. Observations and interviews were carried out with data processing officers and medical record reporting officers, while secondary data was obtained from RL3 Year 2020 at Hospital X Bandung City. Data analysis using least square trend method and Barber Johnson chart. The results showed that the trend of BOR and BTO in Quarter I-IV of 2020 decreased. The trend of AvLOS and TOI in Quarter I and II increased, while in Quarter III and IV it decreased. Based on the results of the study, it can be analyzed that the use of beds at Hospital X Bandung City in 2020 has not been efficient, only reaching 20-60% while the standard value according to Barber Johnson is 75-85%, but it can be predicted that the TOI indicator will be more efficient, while the BOR indicator , AvLOS, and BTO are increasingly inefficient because their values are getting further away from the predetermined standard values. To increase efficiency in the use of beds, the hospital should evaluate the beds and improve the quality of service.
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KIMBALL, RICHARD IAN. ""The Right Sort to Bring to the City": Jack Johnson, Boxing, and Boosterism in Salt Lake City." Utah Historical Quarterly 75, no. 4 (October 1, 2007): 300–321. http://dx.doi.org/10.2307/45063196.
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Dmitriev, Dmitry A., and Christopher H. Dietrich. "Review of the New World Erythroneurini (Hemiptera: Cicadellidae: Typhlocybinae)." Illinois Natural History Survey Bulletin 38, no. 1-6 (August 31, 2007): 59–128. http://dx.doi.org/10.21900/j.inhs.v38.107.
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This review provides descriptions, illustrations, keys for identification, and summaries of distributions and host plants for all known species of the genera Erythroneura (54 species), Erasmoneura (12 species), Rossmoneura (3 species), and Hymetta (5 species). Erythroneura browni sp.n., E. ortha sp.n., E. carinata sp.n., E. glabra sp.n., E. bakeri sp.n., E. kerzhneri sp.n. from Central and Eastern USA, E. triapitsyni sp.n. from New Mexico, Erasmoneura margaritae sp.n. from Illinois, and E. emeljanovi sp.n. from South Carolina are described as new. The following new synonyms are recognized: Erythroneura prima Beamer equals E. maritima Hamilton syn. n.; E. diva McAtee equals E. tricincta var. complementa McAtee syn. n.; E. octonotata Walsh equals E. comes var. compta McAtee syn. n., E. cherokee Robinson syn. n., E. compta var. rufomaculata McAtee syn. n., and E. nigroscuta Johnson syn. n.; E. cymbium McAtee equals E. tricincta var. disjuncta McAtee syn. n.; E. calycula McAtee equals E. tricincta var. erasa McAtee syn. n. and E. tricincta var. noncincta Johnson syn. n.; E. ziczac Walsh equals E. ziczac var. walshi Beamer syn. n.; E. delicata McAtee equals E. comes var. accepta McAtee syn. n., E. scripta Robinson syn. n., and E. tudella Robinson syn. n.; E. rosa Robinson equals E. repetita McAtee, syn. n.; E. kerzhneri sp.n. equals E. vaga sensu Beamer, 1938 (not Johnson, 1934); Erasmoneura vulnerata Fitch equals E. gradata Robinson syn. n.; Erasmoneura fulmina McAtee equals E. bicolorata Beamer syn. n.; Erasmoneura nigra Gillette equals E. vulnerata var. decora McAtee syn. n.; Erasmoneura nigerrima McAtee equals E. atrata Johnson syn. n.; Hymetta balteata McAtee equals H. trifasciata var. albata McAtee syn. n. and H. balteata var. mediana Fairbairn syn. n.; H. anthisma McAtee equals H. distincta Fairbairn syn. n.; Erasmoneura atra Johnson, 1935 is restored and equal to E. nigerrima sensu Beamer, 1946 (not McAtee, 1920). Neotypes are designated for Erythroneura octonotata Walsh, E. tricincta Fitch, and Hymetta trifasciata Say.
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SAMEI, EBRAHIM. "LOCAL PROPERTIES OF THE HOCHSCHILD COHOMOLOGY OF C*-ALGEBRAS." Journal of the Australian Mathematical Society 84, no. 1 (February 2008): 117–30. http://dx.doi.org/10.1017/s1446788708000049.
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AbstractLet A be a C*-algebra, and let X be a Banach A-bimodule. Johnson [B. E. Johnson, ‘Local derivations on C*-algebras are derivations’, Trans. Amer. Math. Soc. 353 (2000), 313–325] showed that local derivations from A into X are derivations. We extend this concept of locality to the higher cohomology of a C*-algebra and show that, for every $n\in \mathbb {N}$, bounded local n-cocycles from A(n) into X are n-cocycles.
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Ulrich, Kristi. "Archaeological Survey of the Proposed Road Improvements at the Lyndon B. Johnson National Historical Park, Johnson City, Gillespie County, Texas." Index of Texas Archaeology: Open Access Gray Literature from the Lone Star State 2009, no. 1 (2009): Article 1. http://dx.doi.org/10.21112/ita.2009.1.1.
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Jones, R. Steven. "A Gallant Little Army: The Mexico City Campaign by Timothy D. Johnson." Southwestern Historical Quarterly 112, no. 3 (2009): 320–21. http://dx.doi.org/10.1353/swh.2009.0117.
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Coiffier, Bertrand, Weimin Li, Erin D. Henitz, J. D. Karkera, Reyna Favis, Dana Gaffney, Alice Shapiro, et al. "Identification of Patient Subgroups Demonstrating Longer Progression-Free Survival (PFS) Benefit with Bortezomib-Rituximab Versus Rituximab in Patients with Relapsed or Refractory Follicular Lymphoma (FL): Biomarker Analyses of the Phase 3 LYM3001 Study." Blood 118, no. 21 (November 18, 2011): 265. http://dx.doi.org/10.1182/blood.v118.21.265.265.
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Abstract Abstract 265 Background: Treatment goals in patients with relapsed FL are to prolong PFS and improve overall survival (OS). To optimize treatment for individual patients, identification of subgroups most likely to benefit from a specific therapy is important. The international, randomized, phase 3 LYM3001 study in patients with relapsed or refractory FL demonstrated improved PFS with bortezomib-rituximab vs rituximab alone (median 12.8 vs 11.0 months, HR 0.822, p=0.039), plus increased overall response rate (ORR; 63% vs 49%, p=0.0004), complete response rate (CR/CRu; 25% vs 18%, p=0.035), and durable (≥6 months) response rate (50% vs 38%, p=0.002) in an unselected patient population. Here we present exploratory biomarker analyses aimed at identifying patient subgroups deriving a longer PFS benefit with bortezomib-rituximab and showing a trend for better OS. Methods: Patients received five 5-week cycles of bortezomib-rituximab (N=336) or rituximab (N=340). Response was assessed using modified International Working Group response criteria. Archived tumor tissue was collected at baseline from 502 (74%) patients; whole blood samples for germ-line DNA were collected on day 1 of cycle 1 from 619 (92%) patients. Protocol-specified candidate biomarkers were based on associations with bortezomib (NF-κB p65, PSMA5, p27, PSMB1/5/8/9) or rituximab (CD68, FCGR2A/3A) activity. Immunohistochemistry assays were used for protein analysis. Taqman SNP assays and PCR/LDR were used for genotyping. Statistical analyses included single-marker analyses, pair-wise combination analyses (n=1140 comparisons), and multiple comparison analyses of all evaluable patients in LYM3001. Clinical covariates included in the analysis were baseline FLIPI score, prior rituximab, time since last anti-lymphoma therapy, region, age, gender, race, Ann Arbor stage, high tumor burden, and number of prior lines of therapy. Results: Single markers and biomarker pairs (n=102) highlighted patient subsets that had significantly improved outcomes with bortezomib-rituximab vs rituximab. For 14 of the pairs, the PFS benefit was ≥6 months. Using false discovery rate (FDR) to control for multiple comparison corrections, one biomarker pair was significant. This pair (presence of the PSMB1 P11A C/G heterozygote, and low CD68 expression [0–50 CD68-positive macrophages in the follicular space]) was associated with significantly improved PFS in patients receiving bortezomib-rituximab vs rituximab (median 16.6 vs 9.1 months, HR 0.407, p<0.0001, FDR=0.051) and had a population frequency of 33% (n=118) in biomarker-evaluable patients (N=356). Patients with high-risk features were represented in the biomarker-selected population (54% high tumor burden, 41% high FLIPI, 30% >2 prior lines of therapy). There was also a trend towards an OS benefit (medians not reached, HR 0.426, p=0.0550), as well as a significantly higher ORR (73.7% vs 47.5%, p=0.0077), a higher CR rate (33.3% vs 23%, p=0.3044), and a significantly longer time to next therapy (median 33.1 vs 14.8 months, p=0.0013). In patients lacking this biomarker pair (N=238) no significant efficacy differences were seen. No other similar studies were available to confirm the reproducibility of these analyses. Therefore, we split the LYM3001 dataset into discovery and confirmation cohorts (7:3 ratio of biomarker-evaluable patients) to enable evaluation and confirmation in independent cohorts of patients The significant biomarker pair of PSMB1 P11A C/G heterozygote and low CD68 was identified in the discovery cohort (N=198) with a PFS advantage with bortezomib-rituximab vs rituximab of 5.7 months (median 14.2 vs 8.4 months, p=0.0003) and an indication of longer OS (HR 0.47, p=0.1291). This biomarker pair also showed a clear PFS advantage in the confirmation cohort (N=108, 8.7-month PFS benefit; median 18.2 vs 9.5 months, HR 0.44, p=0.0817). Other significant biomarker combinations, including combinations of molecular and clinical variables (e.g. high tumor burden) were identified and will be presented. Conclusions: Analyses of the phase 3 LYM3001 trial identified biomarker combinations present in a third of patients offering a significant PFS benefit with bortezomib-rituximab vs rituximab. Use of such biomarker assays in patients with relapsed or refractory FL may aid identification of subgroups deriving maximal benefit from the addition of bortezomib to rituximab therapy. Disclosures: Coiffier: Janssen-Cilag: Consultancy; Roche: Consultancy; Amgen: Consultancy; Sanofi: Consultancy; Pfizer: Consultancy; Millennium Pharmaceuticals, Inc.: Consultancy; Celgene: Consultancy; Pharmacyclics: Consultancy; MedImmune: Consultancy; CTI: Consultancy. Off Label Use: Bortezomib used in combination with rituximab in patients with relapsed/refractory follicular lymphoma. Li:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Henitz:Janssen Research & Development: Employment. Karkera:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Favis:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Gaffney:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Shapiro:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Theocharous:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Elsayed:Janssen Research & Development: Employment; Johson & Johnson: Equity Ownership. de Velde:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Rule:Johnson & Johnson: Advisory Board, Institutional grant, meeting attendance expenses, Honoraria. Walewski:Janssen-Cilag: Institutional/personal grants, advisory board; Hoffman La Roche: Honoraria, Institutional/personal grants, travel/accommodation expenses; Mundipharma: Honoraria; Celgene: Honoraria. de Vos:Millennium Pharmaceuticals, Inc: Consultancy. Crump:Janssen/Ortho-Biotech: Consultancy. Shpilberg:Janssen-Cilag: Consultancy, Honoraria. Cakana:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership. Esseltine:Millennium Pharmaceuticals, Inc: Employment; Johnson & Johnson: Equity Ownership. Mulligan:Millennium Pharmaceuticals, Inc.: Employment. Ricci:Janssen Research & Development: Employment; Johnson & Johnson: Equity Ownership.
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Makowski, Mat, Elshafa Ahmed, Sarah Schlotter, Rebecca Pearson, Rhonda Kitzler, Joseph C. Alvarnas, Jennifer Le Rademacher, et al. "Evaluation of Immune Recovery Following Autologous Hematopoietic Cell Transplantation in HIV-Related Lymphoma: Results of the BMT CTN 0803/AMC 071 Trial." Blood 128, no. 22 (December 2, 2016): 1346. http://dx.doi.org/10.1182/blood.v128.22.1346.1346.
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Abstract Background: Clinical outcomes for patients with HIV-related lymphomas who have undergone autologous hematopoietic cell transplantation (AHCT) are similar to HIV-negative patients (Alvarnas et al., Blood 2016). Here we report a detailed, longitudinal immunophenotypic and functional evaluation of immune recovery of patients enrolled on the BMT CTN 0803/AMC 071 multicenter phase II study (clinicaltrials.gov NCT01141712). Methods: Comprehensive analysis of cellular immunome was performed using 5 color flow cytometry. Acquisition and analysis was performed via FC500 cytometry analyzers with CXP software and prism plot. Comparisons were made between HIV+ and HIV- cohorts of peripheral blood mononuclear cell (PBMC) subsets at 56, 180, and 360 days post AHCT. The HIV- cohort was collected from 30 multiple myeloma patients enrolled in a longitudinal immune recovery study after AHCT (median age 52.5 years (18-71); 57% male, no post AHCT exposure to IMID or other treatment). Control samples were collected from 72 healthy volunteers (median age of 49 (21-68); 53%, M). A Wilcoxon rank sum test was utilized to compare the HIV+ and HIV- groups to controls and to each other at each time point for 18 immune cell subsets common to all three panels. An unsupervised analysis was performed utilizing a principal component analysis (PCA) to look for overall differences in the cohorts. Similar methodologies were used to compare HIV+ to controls that analyzed 100 PBMC subsets. Functional immune recovery was evaluated by IFNg Elispot assay where 2x105 PBMC collected at each time point were pulsed with control, EBV (BZLF1) or HIV (GAG) pepmix preparations. As a control for TCR responsiveness, anti CD3/CD28 antibody-beads were used to immobilize TCR in ELISPOT assay. T cell responses from PBMCs of each of the three time points of HIV+ patients on trial were compared to PBMCs from HIV- donors (n=6). Results: Wilcoxon Rank sum tests show significant differences between transplant patients and controls and between HIV+ and HIV- patients at all visits. There are fewer cell subsets significantly different at day 365 compared to day 56 or 120 in all comparisons. The PCA showed group differences between HIV+, HIV- and control subjects. CD3+/HLA-DR+ (late activation), CD8+/CD25- (cytotoxic T cells) and CD3+/CD314+ (T cells with activating NKG2D) were found to be more prevalent in HIV+ transplant patients. These findings may be consistent with expanded populations of chronically activated cytotoxic T lymphocytes in HIV+ transplant patients. Subsets of NK, Th1 and Th2 cells showed statistically significant differences between HIV+ (low), HIV- (higher) and controls (higher). When the principal components are plotted by visit there is a pattern of both HIV+ and HIV- transplant patients clustering closer to controls as patients recover from AHCT. The PCA was also utilized to compare the HIV+ cohort to controls which had the same panel of cell subsets tested and allowed for the use of 100 cell subsets in the analysis. This analysis showed a similar group separation and pattern of clustering closer to controls in later visits. These findings demonstrate complex interactions between T and NK cell subsets. Functional assessment of antigen-specific T cell responsiveness was evaluated in Elispot assays with EBV (BZLF1) and HIV (GAG) recall antigens and anti-CD3/CD28 controls. Of 30 evaluable patients, 28 HIV+ patients demonstrated measurable IFNg production in response to GAG (spots/2x105 PBMC, range: 8-615), 21 showed measurable response to BZLF1 pepmix (range 12-450); and all patients demonstrated responsiveness to anti CD3/CD28 stimulation. Magnitude of IFNg production from HIV+ samples was generally higher than that observed healthy, HIV- controls. Assessment of NK cell responsiveness is currently underway. Conclusions: While clinical outcomes following AHCT between HIV+ and HIV- patients is comparable, clear distinctions were observed with immune recovery of specific PBMC subsets during the first year following AHCT with differences diminishing as patients recover post transplant. Longitudinal immune responsiveness of PBMC from HIV+ patients to EBV and HIV recall antigens and TCR stimulation generally showed more robust IFNg production compared to PBMCs from HIV- volunteer controls. These data provide further justification supporting AHCT as an option for HIV+ patients provided they meet standard transplant criteria. Disclosures Little: This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award number: Employment. Noy:Pharmacyclics, LLC, an AbbVie Company: Other: travel, accommodations, expenses, Research Funding. Krishnan:celgene: Consultancy, Speakers Bureau; takeda: Consultancy, Speakers Bureau; janssen: Consultancy, Speakers Bureau; onyx: Speakers Bureau. Hofmeister:Signal Genetics, Inc.: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; Arno Therapeutics, Inc.: Research Funding; Incyte, Corp: Membership on an entity's Board of Directors or advisory committees; Janssen: Pharmaceutical Companies of Johnson & Johnson: Research Funding; Karyopharm Therapeutics: Research Funding; Takeda Pharmaceutical Company: Research Funding; Teva: Membership on an entity's Board of Directors or advisory committees. Forman:Mustang Therpapeutics: Other: Construct licensed by City of Hope. Lozanski:Boehringer Ingelheim: Research Funding; Beckman Coulter: Research Funding; Stemline Therapeutics Inc.: Research Funding; Genentech: Research Funding. Baiocchi:Essanex: Research Funding.
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Benyamini, Dubi, Alfredo Ugarte, and Zsolt Bálint. "An updated list of the butterflies of Chile (Lepidoptera, Papilionoidea and Hesperioidea) including distribution, flight period, conservation status and comments on biology. Part III/1, subfamily Polyommatinae (Lycaenidae) with descriptions of three new species of Pseudolucia." Boletín Museo Nacional de Historia Natural 68, no. 2 (December 28, 2019): 131–81. http://dx.doi.org/10.54830/bmnhn.v68.n2.2019.54.
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Parte III/1. Lista actualizada de las mariposas chilenas con 46 especies de la subfamilia Polyommatinae (Lycaenidae). Se confirma para Chile la presencia de Paralycaeides vapa (Staudinger, 1894). Nuevas especies descritas: Pseudolucia malleco Bálint y Benyamini, sp. n., Pseudolucia domeyko y Pseudolucia pascualama Benyamini y Bálint, spp. n. Se establecen sinonimias: Pseudolucia annamaria Bálint y Johnson, 1993 = Pseudolucia clarea Bálint y Johnson, 1993 y Lycaena ludicra Weymer, 1890 = Madeleinea sigal Benyamini, Bálint y Johnson, 1995. Se incluyen datos sobre la distribución regional (D), los períodos de vuelo (FP) y, por primera vez, el estado de conservación (C). Las especies endémicas de Chile (n=27) también están marcadas. La especie Nabokovia ada Bálint y Johnson, 1994, Pseudolucia johnsoni Benyamini y Bálint, 2011, Pseudolucia kechico Bálint, Benyamini y Johnson, 2001 y Pseudolucia faundezi Benyamini y Bálint, 2011 se consideran localmente extintas. El ritmo acelerado de la agricultura y las industrias que producen alteraciones del hábitat está poniendo en peligro muchas de las especies poliamatinas que hay en áreas restringidas debido a que su ciclo de vida esta estrechamente relacionado con sus plantas hospederas y algunas especies de hormigas. En el apéndice, se registra una nueva especie para la fauna chilena, Dione juno miraculosa Hering, 1926 de la Región Arica-Parinacota.
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Brewer Ball, Katherine. "What Kind of Ancestor Do You Want to Be? First Nations Dialogues." TDR/The Drama Review 64, no. 2 (June 2020): 162–70. http://dx.doi.org/10.1162/dram_a_00926.
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Contemporary global indigenous performance, antinormalization of settler structures, and land acknowledgement in Lenapehoking (New York City) performance venues are all explored in 2019’s First Nations Dialogues featuring artists S.J Norman, Allison Akootchook Warden, Emily Johnson, Paola Balla, Genevieve Grieves, and many others.
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Tillett, W., L. Coates, M. Neuhold, E. Theander, P. Bergmans, M. Shawi, M. Perate, C. Contre, and P. Helliwell. "POS1043 STRONG CORRELATION BETWEEN SHORT- VS LONG-FORM COMPOSITE MEASURES OF PSORIATIC ARTHRITIS DISEASE ACTIVITY IN A TNFi-IR POPULATION TREATED WITH GUSELKUMAB: DATA FROM THE PHASE 3b COSMOS TRIAL." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 838–39. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1978.
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BackgroundAccurate assessment of psoriatic arthritis (PsA) disease activity in clinical practice requires a feasible, continuous, multidimensional composite instrument to assess key domains of this heterogeneous disease. While currently available composite tools used in PsA, including the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis Composite Exercise (GRACE) and the PsA Disease Activity Score (PASDAS), are useful in clinical trials, their complexity and time required to complete limit their use in clinical practice.1 Abbreviated instruments, known as 3 visual analogue scale (VAS) and 4VAS, have demonstrated good performance in an observational study, but further testing was recommended.2ObjectivesExplore the correlation between 3VAS or 4VAS and GRACE, PASDAS and measures of quality of life using data from COSMOS.MethodsThe Phase 3b COSMOS study assessed guselkumab (GUS) 100mg Q8W versus placebo (PBO) in tumour necrosis factor inhibitor (TNFi) inadequate response (IR, inadequate efficacy or intolerance) pts with active PsA.3 Pts who received PBO crossed over to GUS at either Week (W) 16 (early escape [EE], n=45/96) or W24 (planned, n=51/96). Each domain of the 3VAS (physician global, pt global, pt skin) and 4VAS (physician global, pt pain, pt joint, pt skin) was evaluated using a 0–10 VAS (higher score=more active disease), and calculated mean scores were plotted over time in apt-continuer population (those with W0 and W48 data). Pearson correlation assessed relationships between observed values over time for 3VAS/4VAS versus GRACE, PASDAS, the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the 36-item Short Form Health Survey Physical Component Summary (SF-36 PCS) score.ResultsData from 285 pts were examined (GUS, n=189; PBO, n=96). Substantial improvements (>45%) were seen in GRACE, PASDAS, 3VAS and 4VAS scores through W48 in GUS-treated pts (Table 1), with separation from PBO as early as W8 (Figure 1). Strong correlations between 3VAS/4VAS and GRACE (r=0.83–0.92)/PASDAS (r=0.72–0.85) were observed in GUS-randomized pts at each visit (Table 1). 3VAS/4VAS showed moderate correlation with HAQ-DI (r=0.45–0.63) and SF-36 PCS (r=–0.40 toTable 1.Observed composite index scores and Pearson correlation coefficients by visitMean (SD)Correlation of 3VAS withCorrelation of 4VAS withVisitGRACEPASDAS3VAS4VASGRACEPASDASGRACEPASDASGUSBLN6.0 (1.1) 1886.4 (1.0) 1876.6 (1.5) 1886.6 (1.5) 1880.850.720.830.72W8N–5.2 (1.3) 1874.5 (1.8) 1884.7 (1.8) 188–0.80–0.81W16 N4.0 (1.7) 1854.7 (1.6) 1844.1 (2.0) 1854.2 (2.1) 1850.910.850.920.85W24 N3.7 (1.6) 1834.3 (1.5) 1823.7 (1.9) 1833.9 (2.0)1830.880.840.890.84W48 N2.8 (1.7) 1653.5 (1.5) 1612.7 (1.9) 1682.8 (2.0) 1680.900.830.900.83PBO→GUS (at W16 [n=45] or W24 [n=51)BL N5.7 (1.0) 966.2 (0.9) 966.1 (1.5) 966.1 (1.5) 960.810.630.830.66W8 N–5.5 (1.3) 935.3 (1.9) 945.3 (1.9) 94–0.78–0.80W16 N5.1 (1.6) 935.5 (1.5) 935.3 (2.1) 945.4 (2.1) 940.910.870.920.88W24 N4.4 (1.4) 934.8 (1.3) 924.4 (1.9) 934.5 (1.9) 930.910.820.900.81W48 N2.9 (1.6) 843.6 (1.4) 842.8 (2.0) 853.0 (2.1) 850.910.860.920.85BL, baseline; SD, standard deviation–0.65). Consistent results were observed in PBO→GUS pts.Figure 1.ConclusionIn these TNFi-IR pts, GUS treatment led to substantial improvements in PsA disease activity through 1 year using several composite indices. All indices, including the 3VAS/4VAS, allowed early discrimination between the GUS and PBO cohorts. The strong correlation between 3VAS/4VAS and GRACE/PASDAS in this pt population is promising and highlights that abbreviated composite indices can provide an accurate assessment of disease activity that may, because of better feasibility, lead to a wider use of such instruments and thus improve pt care. As a next step, thresholds for disease states should be further evaluated.References[1]Tillett W et al. J Rheumatol Suppl 2020;96:11–8[2]Tillett W et al. J Rheumatol Suppl 2021;97:45–9[3]Coates LC et al. Ann Rheum Dis 2021 (epub)Disclosure of InterestsWilliam Tillett Speakers bureau: Abbvie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB, Consultant of: Abbvie, Amgen, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Celgene, Eli Lilly, Janssen, Pfizer, UCB, Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB, Marlies Neuhold Shareholder of: Own Johnson & Johnson stock and/or stock options, Employee of: Employed by Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), Elke Theander Employee of: Employed by Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), Paul Bergmans Shareholder of: Own Johnson & Johnson stock and/or stock options, Employee of: Employed by Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), May Shawi Shareholder of: Own stock in Johnson & Johnson, Employee of: Employed by Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Michelle Perate Shareholder of: Own stock in Johnson & Johnson, Employee of: Employed by Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, Christine CONTRE Shareholder of: Own Johnson & Johnson stock and/or stock options, Employee of: Employed by Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), Philip Helliwell Speakers bureau: Abbvie, Amgen, Novartis, Janssen, Consultant of: Eli Lilly
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Kanygina, Yuliya. "Robert N. Johnson: Self-Improvement: An Essay in Kantian Ethics." Ethical Theory and Moral Practice 15, no. 5 (June 29, 2012): 707–8. http://dx.doi.org/10.1007/s10677-012-9376-1.
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Korotaeva, T., I. Gaydukova, V. Mazurov, A. Samtsov, V. Khayrutdinov, A. Bakulev, M. Kokhan, et al. "OP0226 NETAKIMAB DECREASES DISEASE ACTIVITY IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS FROM A RANDOMIZED DOUBLE-BLIND PHASE 3 CLINICAL TRIAL (PATERA)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 141–42. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3469.
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Background:Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To determine the efficacy and safety of NTK in patients (pts) with active psoriatic arthritis (PsA), based on 24-week (Wk) data from an ongoing phase 3 study (NCT03598751, PATERA).Methods:194 eligible adult pts with PsA (CASPAR, 2006) with inadequate response to csDMARD or one TNFi, were randomized (1:1) to receive NTK 120 mg or placebo (PBO) subcutaneously at Wk 0, 1, 2, 4, 6, 8, 10, 14, 18, 22. 84 pts from PBO arm who did not meet ACR20 (20% improvement of the American College of Rheumatology criteria) by Wk 16 were switched to NTK 120 mg. The primary endpoint was AСR20 at Wk 24. DAPSA (Disease Activity Index for Psoriatic Arthritis), the proportion of pts achieved ACR50/70, minimal disease activity (MDA) (≥5/7 MDA criteria) and Psoriatic arthritis response criteria (PsARC) were also analyzed.Results:Baseline demographics and disease characteristics were similar across treatment arms (Table 1). 80 (82.47%) pts in NTK arm and 9 (9.28%) in the PBO arm achieved ACR20 at Wk 24 (р<0.0001). A significantly greater percentage of NTK-treated pts had ACR50/70, PsARC response, MDA at Wk 24 (Figure 1). By Wk 24 DAPSA significantly improved for NTK vs PBO. DAPSA remission was achieved by 36.08% and 13.40% in NTK and PBO arms, respectively (p=0.003). NTK was well tolerated. The most frequent AEs (≥3%) were lymphopenia, neutropenia, hypercholesterolemia, ALT increased, upper respiratory tract infection, systolic blood pressure increased, hyperglycemia, hyperbilirubinemia. Most AEs were mild to moderate. Severe treatment-related AEs were observed in 1.03% vs 2.06% for NTK and PBO, respectively. No treatment-related SAEs were reported. No anti-drug antibodies were detected.Table 1.Baseline demographics and disease severity characteristicsArmNTK (N=97)PBO (N=97)Age (years) *44.0 (11.66)43.1 (11.88)Male, n (%)52 (53.61)50 (51.55)PsA duration, mo*63.1 (73.12)68.2 (77.49)DAS28-CRP*4.62 (0.97)4.41 (1.11)DAPSA*32.19 (12.23)33.54 (15.98)TJC (66/68) *12.9 (9.97)12.0 (9.88)SJC (66/68) *7.0 (4.93)7.2 (7.18)MTX at baseline83 (85.6)83 (85.6)Previous PsA therapySulfasalazine, n (%)9 (9.28)11 (11.34)Leflunomide, n (%)4 (4.12)8 (8.25)Anti-TNFα, n (%)22 (22.68)17 (17.53)* mean (standard deviation); Mo=months, PsA=psoriatic arthritis, SJC=swollen joint count, TJC=tender joint count, DAS28=Disease Activity Score, MTX=methotrexate, CRP=C-reactive protein, DAPSA=Disease activity index for psoriatic arthritis, TNF=tumor necrosis factorFigure 1.Treatment response at Wk 24Conclusion:NTK is a well-tolerated monoclonal antibody, that provided sustained improvements in signs and symptoms of active PsA through 24 Wks of therapy.Table 2.Safety dataArmNTK (N=97)PBO (N=97)p-valueTreatment-related AEs12 (12.37)7 (7.22)0.2271Treatment-related SAEs0 (0)0 (0)1.002Treatment-related AEs (grade 3-4)1 (1.03)2 (2.06)1.002Local reactions0 (0)0 (0)-Grade 3-4 treatment-related AEsblood pressure increased1 (1.03)0(0)1.002lymphopenia0 (0)2 (2.06)0.4972n (%) are presented,1Pearson’s χ2test,2Fisher’s exact test; N=number of patients, AE=adverse event, SAE=serious adverse event, ALT=Alanine transaminaseAcknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Consultant of: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Speakers bureau: Pfizer, MSD, Novartis, AbbVie, Celgene, JSC BIOCAD, Janssen, UCB, Lilly and Novartis-Sandoz, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD
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Korotaeva, T., I. Gaydukova, V. Mazurov, A. Samtsov, V. Khayrutdinov, A. Bakulev, M. Kokhan, et al. "FRI0346 EFFICACY OF NETAKIMAB IN THE TREATMENT OF AXIAL DISEASE IN PATIENTS WITH PSORIATIC ARTHRITIS: RESULTS OF SUBANALYSIS FROM A DOUBLE-BLIND RANDOMIZED PHASE 3 TRIAL (PATERA)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 767.1–768. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3543.
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Background:The presence of axial involvement significantly impacts on psoriatic arthritis (PsA) activity, outcomes and patients (pts) quality of life. IL-17A inhibitors were previously shown to improve axial disease in PsA. Netakimab (NTK) is a humanized anti-interleukin 17A antibody approved for the treatment of moderate-to-severe plaque psoriasis.Objectives:To evaluate the effects of NTK on axial symptoms in patients with PsA, based on data of 24-week (wk) observation from an ongoing phase 3 PATERA study (NCT03598751).Methods:PATERA is a phase 3 international double-blind, placebo-controlled clinical study. After completion of screening 194 eligible adult patients with PsA fulfilling the CASPAR criteria, with inadequate response to csDMARD or one TNFi, were randomly assigned (1:1) to receive NTK 120 mg or placebo (PBO) at Wks 0, 1, 2, 4, 6, 8, 10, 14, 18 and 22. 84 patients from PBO arm, failed to achieve ACR20 (20% improvement the American College of Rheumatology criteria) by Wk 16, were switched to NTK. A subset of pts with axial involvement (defined by presence of inflammatory back pain (IBP) according to ASAS IBP criteria, 2009) was evaluated with spondylitis-specific assessments: spinal pain (10-item numerical rating scale), nocturnal back pain (10-item numerical rating scale), BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score with C-reactive protein.Results:104 PsA patients (NTK N=54, PBO N=50) with IBP at baseline (BL) were included in the analysis. Demographic and BL disease characteristics were comparable across the groups (Table 1). During the analyzed period, BASDAI and ASDAS-CRP scores significantly decreased in NTK-treated patients (Figure 1). Maximum decrease in axial disease activity developed by Wk 4-8 depending on index of assessment. The achieved values maintained throughout the entire analyzed period (Table 2). At Wk 24, mean changes in ASDAS-CRP and BASDAI were -1.57 and -2.83 in NTK arm vs -0.11 and -0.19 in PBO arm respectively (p<0.0001).Table 1.Baseline demographics and mean composite endpoint scoresArmNTK (N=54)PBO (N=50)Age (years)*43.5 (12.16)42.7 (10.76)Male, n (%)27 (50)26 (52)PsA duration, mo*70.0 (78.78)79.0 (81.62)BASDAI score*5.58 (1.80)5.79 (1.94)ASDAS-CRP score*3.38 (1.16)3.38 (1.28)nocturnal pain*4.2 (2.42)5.1 (2.29)spinal pain*4.4 (2.41)5.3 (2.40)* mean (standard deviation) BASDAI=Bath Ankylosing Spondylitis Disease Activity Index, ASDAS-CRP=Ankylosing Spondylitis Disease Activity Score with C-reactive proteinTable 2.Changes in BASDAI and ASDAS-CRP vs baselineBASDAIASDAS-CRPNTK (N=54)PBO (N=50)NTK (N=54)PBO (N=50)Wk 4-2.45 (1.94)-0.51 (1.26)-1.44 (1.06)-0.19 (0.60)Wk 8-2.77 (2.22)-0.38 (1.55)-1.53 (1.07)-0.21 (0.74)Wk 16-2.77 (1.83)-0.17 (1.67)-1.52 (0.98)-0.10 (0.97)Wk 24-2.83 (2.15)-0.19 (1.70)-1.57 (1.06)-0.11 (0.95)mean (standard deviation)Figure 1.Mean change in BASDAI, ASDAS-CRP, spinal pain, and nocturnal pain at Wk 24Conclusion:About 50% of subjects, randomized to PATERA study, had IBP at baseline. NTK leads to rapid and sustained improvement in axial disease in patients with active PsA.Acknowledgments:This study was sponsored by JSC BIOCAD.Disclosure of Interests:Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: Pfizer, Novartis, AbbVie, JSC BIOCAD, Сelgene, MSD, Sanofi, V Mazurov: None declared, Aleksey Samtsov Grant/research support from: JSC BIOCAD, Novartis, Eli Lilly, Johnson&Johnson, Celgene, Glenmark, Galderma, Sanofi, Vladislav Khayrutdinov Grant/research support from: Akrikhin, Alkoy, Belupo, JSC BIOCAD, Bosnaliejk, Verteks, Glenmark, Elfa, Leo Pharma, MSD, Novartis, Pfizer, Sun Pharma, Sanofi, Celgene, Pharmtec, AbbVie, Eli Lilly, Jadran, Janssen, Andrey Bakulev Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Muza Kokhan Grant/research support from: AbbVie, Eli Lilly, Pfizer, UCB, MSD, Novartis, Galderma, Celgene, Leo Pharma and Johnson&Johnson, JSC BIOCAD, Consultant of: Novartis, Celgene and Johnson&Johnson, Speakers bureau: AbbVie, Eli Lilly, Galderma, UCB, Novartis, Celgene and Johnson&Johnson, Alena Kundzer: None declared, Nikolaj Soroka Grant/research support from: JSC BIOCAD, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Employee of: JSC BIOCAD