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Schmeding, A., e M. Schneider. "Fatigue, health-related quality of life and other patient-reported outcomes in systemic lupus erythematosus". Best Practice & Research Clinical Rheumatology 27, n. 3 (giugno 2013): 363–75. http://dx.doi.org/10.1016/j.berh.2013.07.009.
Testo completo
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Magro-Checa, C., L. J. J. Beaart-van de Voorde, H. A. M. Middelkoop, M. L. Dane, N. J. van der Wee, M. A. van Buchem, T. W. J. Huizinga e G. M. Steup-Beekman. "Outcomes of neuropsychiatric events in systemic lupus erythematosus based on clinical phenotypes; prospective data from the Leiden NP SLE cohort". Lupus 26, n. 5 (aprile 2017): 543–51. http://dx.doi.org/10.1177/0961203316689145.
Testo completoAbstract (sommario):
Objective The objective of this study was to assess whether clinical and patient’s reported outcomes are associated with a different pathophysiological origin of neuropsychiatric events presenting in systemic lupus erythematosus. Methods A total of 232 neuropsychiatric events presenting in 131 systemic lupus erythematosus patients were included. Neuropsychiatric systemic lupus erythematosus diagnosis was established per event by multidisciplinary evaluation. All neuropsychiatric events were divided according to a suspected underlying pathophysiological process into one of the following: non-neuropsychiatric systemic lupus erythematosus related, inflammatory and ischaemic neuropsychiatric systemic lupus erythematosus. The clinical outcome of all neuropsychiatric events was determined by a physician-completed four-point Likert scale. Health-related quality of life was measured with the subscales of the patient-generated Short Form 36 (SF-36) health survey questionnaire. The change between scores at paired visits of all domain scores, mental component summary (SF-36 MCS) and physical component summary (SF-36 PCS) scores were retrospectively calculated and used as patient-reported outcome. The association among these outcomes and the different origin of neuropsychiatric events was obtained using multiple logistic regression analysis. Results The clinical status of 26.8% non-neuropsychiatric systemic lupus erythematosus events, 15.8% ischaemic neuropsychiatric systemic lupus erythematosus and 51.6% inflammatory neuropsychiatric systemic lupus erythematosus improved after re-assessment. Almost all SF-36 domains had a positive change at re-assessment in all groups independently of the origin of neuropsychiatric events. Neuropsychiatric systemic lupus erythematosus ( B = 0.502; p < 0.001) and especially inflammatory neuropsychiatric systemic lupus erythematosus ( B = 0.827; p < 0.001) had better clinical outcome, with change in disease activity being the only important predictor. The change in SF-36 MCS was also independently associated with neuropsychiatric systemic lupus erythematosus ( B = 5.783; p < 0.05) and inflammatory neuropsychiatric systemic lupus erythematosus ( B = 11.133; p < 0.001). Disease duration and change in disease activity were the only predictors in both cases. The change in SF-36 PCS was only negatively associated with age. Conclusion Inflammatory neuropsychiatric systemic lupus erythematosus events have better clinical outcome and meaningful improvement in SF-36 MCS than ischaemic neuropsychiatric systemic lupus erythematosus or non-neuropsychiatric systemic lupus erythematosus.
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Rodríguez-Rivera, Diana V., Yerania Rodríguez-Navedo, Mariely Nieves-Plaza e Luis M. Vilá. "Patient-reported outcome measures in a population of medically indigent patients with systemic lupus erythematosus in Puerto Rico". SAGE Open Medicine 4 (1 gennaio 2016): 205031211667092. http://dx.doi.org/10.1177/2050312116670927.
Testo completoAbstract (sommario):
Objective: To determine patient-reported outcomes measures in indigent patients with systemic lupus erythematosus receiving their healthcare through the Puerto Rico government managed care system and compare these measures with non-indigent patients treated in a private fee-for-service setting. Methods: A cross-sectional study was conducted in a cohort of 98 Puerto Ricans with systemic lupus erythematosus. Patients from the public group (n = 40) were treated in a university-based specialized systemic lupus erythematosus clinic and the private group (n = 58) in a community-based rheumatology practice. Demographic and clinical features and patient-reported outcomes measures per LupusPRO instrument were determined. LupusPRO captures quality-of-life measures in 12 domains. Differences among study groups were examined using chi-square, Fisher’s exact, t-tests, and the Wilcoxon signed-rank test. Results: The mean (standard deviation) age of the study population was 44.9 (12.0) years; 94 (95.9%) were women. Patients in the public setting were younger and were more likely to have renal disease and elevated anti-double-stranded DNA antibodies, and being treated with azathioprine and cyclophosphamide. Patients from the public sector were more likely to have better quality-of-life measures in the LupusPRO domains of pain/vitality and coping. No significant differences were observed for the domains of lupus symptoms, physical health, emotional health, body image, cognition, procreation, lupus medications, desires/goals, social support, and satisfaction with medical care. Conclusion: Despite having a lower socioeconomic status and worse clinical status, systemic lupus erythematosus patients from the public sector had equal or better patient-reported outcomes measures than those treated in the private setting. This favorable outcome may be associated with the comprehensive healthcare received by these patients in a specialized lupus clinic.
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Saletra, A., J. Meenakshi, K. Fronczyk, Z. Czuszyńska, M. Sierakowska, M. Szmyrka e M. Olesińska. "AB1490 THE POLISH VALIDATION OF A DISEASE SPECIFIC PATIENT REPORTED OUTCOME MEASURE OF SYSTEMIC LUPUS ERYTHEMATOSUS". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 1849. http://dx.doi.org/10.1136/annrheumdis-2022-eular.5335.
Testo completoAbstract (sommario):
BackgroundSystemic Lupus Erythematosus (SLE) is a chronic multisystemic autoimmune disease with a very broad clinical picture. Due to its generalized nature, it affects all aspects of the patient’s life, such as physical, psychological and social well-being. As a result, the quality of life in patients with SLE is substantially decreased. Therefore, it is recommended to introduce evaluation of quality of life in clinical trials and in the daily practice.LupusPRO is a disease-targeted, patient reported outcome measure developed for assessment of quality of life in patients with Systemic Lupus Erythematosus. Originally, the questionnaire was validated among US patients of varied ethnic background and both genders.What differs LupusPRO from previous disease-specific quality of life questionnaire used in SLE is its comprehensiveness. It comprises two constructs: health- related quality of life domains (HRQOL) and non- health - related quality of life domains.ObjectivesThe aim of this study is to carry out a cross-cultural adaptation and validation of the Polish-translated version of LupusPRO.MethodsThe Polish version of LupusPRO was administrated along with the 36-Item Short Form Health Survey (SF-36) and EQ-5D-5L questionnaire and Hospital Anxiety and Depression Scale (HADS). At the same time, demographics and clinical characteristics were collected. Disease activity, damage and exacerbation were assessed using SELENA-SLEDAI, SLICC/ACR DI and LFA Flare. Internal consistency reliability, test-retest reliability, convergent validity (against corresponding domains of SF-36) and criterion validity (against disease activity and damage) and known group validity were tested.ResultsA total of 199 (91% females) patients with SLE with a mean age of 42.6 ⊥12.62 years participated in the study. The mean SELENA-SLEDAI reached 5.3(⊥ 5.9) points and SLICC/ACR DI was observed at 1.3(⊥ 2.0) points. The internal consistency reliability of LupusPRO domains ranged between 0.737-0.925 (except for Lupus Symptoms, Social Support, Coping and Satisfaction with care). For all domains, except Social Support, test-retest reliability exceeded 0.7. Convergent validity with corresponding domains of the SF-36 was good (r>0,5). All health-related quality of life domains performed well against disease activity and damage measure, establishing its criterion validity. Known group validity against disease activity was observed. Confirmatory factor analysis showed a good fit.ConclusionThe Polish version of LupusPRO has proved to have fair psychometric properties among Polish patients with SLE. It is the first disease-specific quality of life questionnaire in Polish, validated among Polish patients with Systemic Lupus Erythematosus.References[1]Jolly M, Pickard AS, Block JA et al. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum. 2012: 42(1): 56-65. doi:10.1016/j.semarthrit.2011.12.005.Disclosure of InterestsNone declared
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BALITSKY, AMARIS K., VALENTINA PEEVA, JIANDONG SU, ELAHEH AGHDASSI, ERIC YEO, DAFNA D. GLADMAN, MURRAY B. UROWITZ e PAUL R. FORTIN. "Thrombovascular Events Affect Quality of Life in Patients with Systemic Lupus Erythematosus". Journal of Rheumatology 38, n. 6 (1 marzo 2011): 1017–19. http://dx.doi.org/10.3899/jrheum.101054.
Testo completoAbstract (sommario):
Objective.To compare health-related quality of life (HRQOL) of patients with antiphospholipid syndrome (APS) and systemic lupus erythematosus (SLE) with and without previous thrombovascular events (TE).Methods.The Medical Outcomes Study Short-Form 36 (SF-36) was used to assess HRQOL in 5 patient groups: (1) primary APS (PAPS; n = 35); (2) APS associated to SLE (SAPS; n = 37); (3) SLE+TE without persistent positive antiphospholipid antibody (SLE+TE–aPL; n = 75); (4) SLE–TE+aPL (n = 71); and (5) SLE–TE–aPL (n = 608).Results.The data on both mental component summary and physical component summary (PCS) scores showed an impaired quality of life in all patient groups. Patients in the SLE+TE–aPL group had a lower PCS score compared to patients in the SLE–TE+aPL group.Conclusion.The combination of SLE and TE has a more negative influence on reported HRQOL, compared to having SLE or APS alone.
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Moiseev, S., P. Novikov e N. Bulanov. "Systemic lupus erythematosus: epidemiology, outcomes and burden". Clinical pharmacology and therapy 31, n. 4 (13 novembre 2021): 13–22. http://dx.doi.org/10.32756/0869-5490-2021-4-13-22.
Testo completoAbstract (sommario):
The estimates of incidence and prevalence of systemic lupus erythematosus (SLE) in Europe are 1.5-4.9 per 100 000 persons-years and 30-70 per 100 000 people, respectively. Over the last 50 years, survival in SLE patients has improved significantly. Moreover, immunosuppressive treatment resulted in a decreased risk of death from active disease, whereas infections and cardiovascular disease have become the main causes of death in SLE populations. Almost 70% of SLE patients have recurrent course of disease, although long-term remissions or persistent disease activity also occur in a proportion of patients. Annually, every third SLE patient develops moderately severe or severe flares. Recurrent flares, complications of immunosuppressive treatment and comorbidity are associated with accrual of organ damage that increases the risk of death. SLE patients have impaired health-related quality of life correlating with both disease activity and organ damage. Being on remission of SLE or on low disease activity is associated with better outcomes, including lower mortality and risk of damage or flares, improved quality of life, lower hospitalisation rates and costs. Glucocorticoids remain the mainstay of SLE treatment, although their use should be limited, e.g. by proper administration of immunosuppressive or antiinflammatory agents that have steroid-sparing activity. Treatment and prevention of infections and cardiovascular outcomes are also essential for further improvement of survival of SLE patients.
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Elefante, Elena, Chiara Tani, Chiara Stagnaro, Francesco Ferro, Alice Parma, Linda Carli, Viola Signorini et al. "Impact of fatigue on health-related quality of life and illness perception in a monocentric cohort of patients with systemic lupus erythematosus". RMD Open 6, n. 1 (febbraio 2020): e001133. http://dx.doi.org/10.1136/rmdopen-2019-001133.
Testo completoAbstract (sommario):
BackgroundFatigue is a very common and debilitating symptom in patients with systemic lupus erythematosus (SLE), even among those with a mild or inactive disease. The objective of this study is to define fatigue determinants and describe the impact of fatigue on health-related quality of life (HRQoL) and illness perception in a monocentric cohort of patients with SLE.MethodsThis is a cross-sectional study. Adult patients with SLE were included. For each patient, demographics, medications, comorbidities, organ damage (Systemic Lupus International Collaborating Clinics Damage Index), active disease manifestations and Systemic Lupus Disease Activity Index scores were collected. It was evaluated if each patient met the definitions of remission and low disease activity. At enrolment, each patient completed the Short Form-36 (SF-36), Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F), Lupus Impact Tracker (LIT), Systemic Lupus Activity Questionnaire (SLAQ) and Brief Index of Lupus Damage (BILD). The FACIT-F questionnaire was also administered to a group of healthy controls.Results223 patients were included (mean age 44.9±13.2 years, median disease duration 13 years). 18.2% had an active disease, 43.5% met the definition of remission on treatment, and 11.8% had a concomitant fibromyalgia. The median FACIT-F score of our cohort was significantly lower compared with that of healthy controls (40 vs 47; p<0.001). FACIT-F scores were irrespective of age, disease duration, disease activity and damage. FACIT-F score was significantly lower in patients with fibromyalgia (p<0.01). FACIT-F scores demonstrated a significant correlation with all other patient-reported outcomes: SF-36 (r=0.53–0.77), LIT (r=−0.78), SLAQ (r=−0.72) and BILD (r=−0.28).ConclusionsFatigue in patients with SLE has a strong negative impact on HRQoL and patient perception of the disease burden. Fatigue seems irrespective of disease activity but significantly influenced by the presence of fibromyalgia.
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Elkaraly, N. E., S. I. Nasef, A. S. Omar, A. M. Fouad, J. Meenakshi e A. E. Mohamed. "AB1238 THE ARABIC LUPUSPRO: CROSS-CULTURAL VALIDATION OF A DISEASE-SPECIFIC PATIENT-REPORTED OUTCOME TOOL FOR QUALITY OF LIFE IN LUPUS PATIENTS". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 1909.1–1910. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4042.
Testo completoAbstract (sommario):
Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with high morbidity and disability that affects all aspects of quality of life (QoL).(1)LupusPRO is a disease-targeted patient-reported outcome tool for the measurement of health and non-health related quality of life (HRQoL and Non-HRQoL) in SLE patients.(2)Objectives:To translate, cross-culturally adapt, and validate the LupusPRO v.1.8 into the Arabic Language.Methods:LupusPRO v.1.8 was translated into Arabic following the forward-backward translation guideline.(3)The Arabic version of LupusPRO was subsequently applied to 107 Egyptian SLE patients. To assess test-retest reliability, the Arabic LupusPRO was completed on two occasions, two weeks apart. Validation was performed against the Arabic version of Medical Outcomes Study Short Form (SF-36), the Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index (SDI). Discriminant validity of Arabic LupusPRO was evaluated against the SF-36 (item 1), while the conceptual framework was evaluated by the confirmatory factor analysis (CFA).Results:The study included 107 patients, 95% of whom were women. Their median age was 32 (range:18-55) years. Arabic LupusPRO’s Cronbach’s alpha ranged from 0.71 to 0.98 except for the social support domain (0.65). Test-retest reliability ranged from 0.83 to 0.98. Convergent validity with corresponding domains of the SF-36 was satisfactory. Criterion validity showed a weak and non-significant correlation of lupusPRO domains with SDI except for physical domain and significant weak correlation with SELENA-SLEDAI (Table1). Discriminant validity showed acceptable results against the SF-36 (item 1). The CFA showed good model fit indices for the hypothesized item-to-scale relationships (CFI =0.988, TLI = 0.987, and RMSEA=0.062), with most of item-to-scale loadings greater than 0.9.Conclusion:The Arabic version of LupusPRO v1.8 is a reliable and valid tool for measuring QoL(HRQoL and Non-HRQoL) in Arabic-speaking SLE patients.References:[1]Mcelhone K, Abbott J, Teh L-SJL. A review of health- related quality of life in systemic lupus erythematosus. Lupus 2006;15(10):633-43.[2]Jolly M, Pickard AS, Block JA, et al. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum. 2012;42(1):56–65.[3]Beaton D, Bombardier C, Guillemin F, Ferraz M. Guidelines for the Process of Cross-Cultural Adaption of Self-Report Measures. Spine. 2001;25:3186-91.Table 1.Validity of the Arabic LupusPRO against disease activity, damage index and SF-36LupusPRO DomainValiditySF-36Total SLEDAITotal SDIDomainRho (P)Rho (P)Rho (P)Lupus Symptoms-0.25 (0.010)-0.17 (0.08)Cognition-0.15 (0.117)-0.21 (0.03)Lupus Medications-0.22 (0.021)-0.37 (0.001)Procreation0.003 (0.977)-0.20 (0.04)Physical HealthRF0.84 (<0.001)-0.34 (<0.001)-0.31 (0.001)RP0.75 (<0.001)Sleep-0.32 (0.001)-0.09 (0.33)FatigueVT0.80 (<0.001)-0.33 (0.001)-0.12 (0.33)PainBP0.86 (<0.001)-0.22 (0.026)-0.18 (0.07)Emotional HealthMH0.74 (<0.001)-0.33 (0.001)-0.19 (0.05)RE0.80 (<0.001)Body Image-0.30 (0.002)-0.25 (0.008)Desire/Goals-0.28 (0.004)-0.10 (0.30)Social Support0.22 (0.02)-0.20 (0.04)Coping0.07 (0.461)-0.20 (0.03)Satisfaction of Medical Care0.18 (0.066)-0.11 (0.24)HRQoLGH0.81 (<0.001)-0.37 (<0.001)-0.28 (0.004)None-HRQoL-0.08 (0.42)-0.26 (0.007)PF: Physical functioning; RP: role physical; RE: role emotional; VT: vitality; MH: Mental health; BP: Bodily Pain; GH: General health.Disclosure of Interests:None declared
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Parodis, Ioannis, e Paul Studenic. "Patient-Reported Outcomes in Systemic Lupus Erythematosus. Can Lupus Patients Take the Driver’s Seat in Their Disease Monitoring?" Journal of Clinical Medicine 11, n. 2 (11 gennaio 2022): 340. http://dx.doi.org/10.3390/jcm11020340.
Testo completoAbstract (sommario):
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder that has detrimental effects on patient’s health-related quality of life (HRQoL). Owing to its immense heterogeneity of symptoms and its complexity regarding comorbidity burden, management of SLE necessitates interdisciplinary care, with the goal being the best possible HRQoL and long-term outcomes. Current definitions of remission, low disease activity, and response to treatment do not incorporate self-reported patient evaluation, while it has been argued that the physician’s global assessment should capture the patient’s perspective. However, even the judgment of a very well-trained physician might not replace a patient-reported outcome measure (PROM), not only owing to the multidimensionality of self-perceived health experience but also since this notion would constitute a direct contradiction to the definition of PROMs. The proper use of PROMs is not only an important conceptual issue but also an opportunity to build bridges in the partnership between patients and physicians. These points of consideration adhere to the overall framework that there will seldom be one single best marker that helps interpret the activity, severity, and impact of SLE at the same time. For optimal outcomes, we not only stress the importance of the use of PROMs but also emphasize the urgency of adoption of the conception of forming alliances with patients and facilitating patient participation in surveillance and management processes. Nevertheless, this should not be misinterpreted as a transfer of responsibility from healthcare professionals to patients but rather a step towards shared decision-making.
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Fangtham, M., S. Kasturi, R. R. Bannuru, J. L. Nash e C. Wang. "Non-pharmacologic therapies for systemic lupus erythematosus". Lupus 28, n. 6 (8 aprile 2019): 703–12. http://dx.doi.org/10.1177/0961203319841435.
Testo completoAbstract (sommario):
Background Non-pharmacologic therapies have been deemed as potentially beneficial for patients with systemic lupus erythematosus. We conducted an updated review to determine the effects of these therapies to inform practice. Methods A literature search was performed using PubMed (MEDLINE), EMBASE, Cochrane, PsychINFO, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Google Scholar from inception until August 2018. We included randomized controlled trials of non-pharmacologic therapies in systemic lupus erythematosus patients with sample size ≥10. Systemic lupus erythematosus was defined by 1982 or 1997 American College of Rheumatology criteria. Studies were synthesized separately by patient-reported outcomes and disease activity. Due to the heterogeneity of interventions and comparisons, a meta-analysis was not performed. Results A total of 15 randomized controlled trials involving 846 participants met the inclusion criteria. Of the 15 trials, eight used exercise interventions, six used psychological interventions (one group psychotherapy, three cognitive behavioral therapies, one psychoeducation, one mindfulness-based cognitive therapy) and one used electro-acupuncture. Five of 15 studies utilized control groups consisting of usual medical care. Other studies included control interventions of relaxation, attention placebo, symptom monitoring support, education, minimal needling, isotonic and resistance exercise. Compared with the control conditions, non-pharmacological interventions were associated with a significant improvement in fatigue in three out of six studies. Three out of eight studies reported improved anxiety and depression, and one study reported improved pain after interventions. Seven out of 11 studies reported improvement in overall quality of life in at least one domain of the Short-Form Health Survey. Of note, no studies demonstrated an improvement in disease activity after 5–52 weeks of non-pharmacological therapies. Conclusion This review showed promising results for physical exercise and psychological interventions as adjuncts to traditional medical therapy for improvement in fatigue, depression, pain and quality of life for systemic lupus erythematosus. Further high-quality randomized controlled trials with longer follow-up periods are warranted.
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Strand, Vibeke, Lee S. Simon, Alexa Simon Meara e Zahi Touma. "Measurement properties of selected patient-reported outcome measures for use in randomised controlled trials in patients with systemic lupus erythematosus: a systematic review". Lupus Science & Medicine 7, n. 1 (giugno 2020): e000373. http://dx.doi.org/10.1136/lupus-2019-000373.
Testo completoAbstract (sommario):
ObjectiveThe heterogeneous multisystem manifestations of SLE include fatigue, pain, depression, sleep disturbance and cognitive dysfunction, and underscore the importance of a multidimensional approach when assessing health-related quality of life. The US Food and Drug Administration has emphasised the importance of patient-reported outcomes (PROs) for approval of new medications and Outcome Measures in Rheumatology has mandated demonstration of appropriate measurement properties of selected PRO instruments.MethodsPublished information regarding psychometric properties of the Medical Outcomes Survey Short Form 36 (SF-36), Lupus Quality of Life Questionnaire (LupusQoL) and Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), and their suitability as end points in randomised controlled trials (RCTs) and longitudinal observational studies (LOS) were assessed. A search of English-language literature using MEDLINE and EMBASE identified studies related to development and validation of these instruments. Evidence addressed content validity, reliability (internal consistency and test-retest reliability), construct validity (convergent and divergent) and longitudinal responsiveness, including thresholds of meaning and discrimination.ResultsAll instruments demonstrated strong internal consistency, reliability and appropriate face/content validity, indicating items within each instrument that measure the intended concept. SF-36 and LupusQoL demonstrated test-retest reliability; although not published with FACIT-F in SLE supported by evidence from other rheumatic diseases. All instruments demonstrated convergent validity with other comparable PROs and responsivity to treatment.ConclusionThe measurement properties of PRO instruments with published data from RCTs including: SF-36, LupusQoL and FACIT-F indicate their value as secondary end points to support labelling claims in RCTs and LOS evaluating the efficacy of SLE treatments.
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Jolly, M., N. Annapureddy, L. Arnaud e H. Devilliers. "Changes in quality of life in relation to disease activity in systemic lupus erythematosus: post-hoc analysis of the BLISS-52 Trial". Lupus 28, n. 14 (1 novembre 2019): 1628–39. http://dx.doi.org/10.1177/0961203319886065.
Testo completoAbstract (sommario):
Objectives To quantify changes in generic patient-reported outcomes against clinically meaningful, disease activity measures in systemic lupus erythematosus (SLE). Methods Using BLISS-52 trial data (867 SLE patients), we estimated the mean difference in change of patient-reported outcome scores (Medical Outcomes Study SF-36 and FACIT-fatigue) in relation to disease activity (SELENA-SLEDAI, SELENA-SLEDAI flare index, SLE responder index and British Isles Lupus Assessment Group (BILAG)), considering all study visits by the mean of multivariate mixed models. Predefined disease activity criteria were used to define for improvement and worsening. Results Mean changes in physical component summary/mental component summary and FACIT-fatigue in response to changes in SELENA-SLEDAI and SELENA-SLEDAI flare index were significantly lower than 2.5. New SELENA-SLEDAI flare index flare led to a significant change in all patient-reported outcome scores, except role emotional. Mean improvement in patient-reported outcomes with achievement of SLE responder index ranged between +6.2 (physical function) and +11.3 (bodily pain) for SF-36 domains, + 3.4 and +3.3 for mental component summary and physical component summary, and was +4.2 for FACIT-fatigue. When considering disease activity changes by organ system, changes in BILAG (constitutional) was independently associated with significant changes in FACIT-fatigue and all SF-36 domains (except physical function), changes in BILAG (musculoskeletal and hematological) were independently associated with significant changes in patient-reported outcome scores, except for role emotional (musculoskeletal) and general health/mental health (hematological). Mean changes in every SF-36 domain varied (and was >5) with SLE responder index attainment. Conclusions Knowledge of changes in patient-reported outcomes, against clinically meaningful changes in SLE disease activity measures, is crucial for designing of clinical trials, interpretation of results and shared decision-making for patient care.
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Eraslan, E., R. Bilici Salman, H. Satiş, A. Avanoglu Guler, H. Karadeniz, H. Küçük, S. Haznedaroglu, M. A. Ozturk, A. Tufan e B. Goker. "AB0300 LUPUS DISEASE ACTIVITY CORRELATES WITH QUALITY OF LIFE BUT NOT WITH HEALTH LITERACY STATUS". Annals of the Rheumatic Diseases 80, Suppl 1 (19 maggio 2021): 1176.2–1176. http://dx.doi.org/10.1136/annrheumdis-2021-eular.581.
Testo completoAbstract (sommario):
Background:Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology that can affect any organ of the body. SLE is associated with adverse effects on both health and non-health-related quality of life (HRQOL and non-HRQOL). Lupus PRO is a patient reported outcome measure that has been validated in many languages. It has 44 items that cover both HRQOL and non-HRQOL (1). Health literacy is defined as the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions. Multiple studies indicate that people with limited health literacy have worse health status and higher rates of hospitalization (2).Objectives:We aimed to evaluate the relationship between the LLDAS (Lupus Low Disease Activity State) criteria and the Lupus PRO test, as well as the health literacy status of lupus patients.Methods:83 SLE patients (94% women) were included in the study. We performed Lupus PRO and the European Health Literacy Survey tests during the routine follow-up visits of lupus patients to our rheumatology outpatient clinic and admissions to rheumatology inpatient clinic. Available clinical data on medical records were obtained, physician global assessments (PGA) were recorded by the attending physician.Results:LLDAS criteria strongly and inversely correlated with the total score, as well as the mood subunit of the Lupus PRO. Similarly, it also significantly inversely correlated with the body appearence and goals subunits. Health literacy status of the patients did not correlate with their LLDAS scores, ie their disease activities.Conclusion:Our results suggest that lupus disease activity, assessed by LLDAS criteria, significantly correlates with measures of quality of life, spesicifically Lupus PRO test, but not with health literacy status. Further studies are needed to evaluate if health literacy is related with damage, hospitalization or mortality associated with lupus.References:[1]Jolly M, Pickard AS, Block JA, Kumar RB, Mikolaitis RA, Wilke CT, et al., editors. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Seminars in arthritis and rheumatism; 2012: Elsevier.[2]Paasche-Orlow MK, Parker RM, Gazmararian JA, Nielsen-Bohlman LT, Rudd RR. The prevalence of limited health literacy. Journal of general internal medicine. 2005;20(2):175-84.Disclosure of Interests:None declared
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Ugarte-Gil, Manuel Francisco, Claudia Mendoza-Pinto, Cristina Reátegui-Sokolova, Guillermo J. Pons-Estel, Ronald F. van Vollenhoven, George Bertsias, Graciela S. Alarcon e Bernardo A. Pons-Estel. "Achieving remission or low disease activity is associated with better outcomes in patients with systemic lupus erythematosus: a systematic literature review". Lupus Science & Medicine 8, n. 1 (settembre 2021): e000542. http://dx.doi.org/10.1136/lupus-2021-000542.
Testo completoAbstract (sommario):
BackgroundRemission and low disease activity (LDA) have been proposed as the treatment goals for patients with systemic lupus erythematosus (SLE). Several definitions for each have been proposed in the literature.ObjectiveTo assess the impact of remission/LDA according to various definitions on relevant outcomes in patients with SLE.MethodsThis systematic literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses using PubMed (1946–week 2, April 2021), Cochrane library (1985–week 2, week 2, April 2021) and EMBASE (1974–week 2, April 2021). We included longitudinal and cross-sectional studies in patients with SLE reporting the impact of remission and LDA (regardless their definition) on mortality, damage accrual, flares, health-related quality of life and other outcomes (cardiovascular risk, hospitalisation and direct costs). The quality of evidence was evaluated using the Newcastle-Ottawa Scale.ResultsWe identified 7497 articles; of them, 31 studies met the inclusion criteria and were evaluated. Some articles reported a positive association with survival, although this was not confirmed in all of them. Organ damage accrual was the most frequently reported outcome, and remission and LDA were reported as protective of this outcome (risk measures varying from 0.04 to 0.95 depending on the definition). Similarly, both states were associated with a lower probability of SLE flares, hospitalisations and a better health-related quality of life, in particular the physical domain.ConclusionRemission and LDA are associated with improvement in multiple outcomes in patients with SLE, thus reinforcing their relevance in clinical practice.PROSPERO registration numberCRD42020162724.
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Gomez, A., J. Lindblom, V. Qiu, A. Cederlund, A. Borg, S. Emamikia, Y. Enman, J. Lampa e I. Parodis. "POS0101 ADVERSE HEALTH-RELATED QUALITY OF LIFE OUTCOME DESPITE ADEQUATE CLINICAL RESPONSE TO TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS". Annals of the Rheumatic Diseases 80, Suppl 1 (19 maggio 2021): 260.2–261. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1472.
Testo completoAbstract (sommario):
Background:Despite improvements in medical care that have contributed to prolonged life expectancy for people living with systemic lupus erythematosus (SLE) over the past decades, they still suffer from substantial diminutions of health-related quality of life (HRQoL) compared with the general population and with other chronic diseases.Some studies have demonstrated that conventional synthetic and biological disease-modifying agents contribute to improvements in SLE patients’ HRQoL, and responders to treatment have been shown to report greater improvements than non-responders. Although these observations are clinically relevant, improvement following a therapeutic intervention does not necessarily signify that the individual has achieved a satisfactory health state perception. In rheumatoid arthritis, significant pain and severe fatigue persist in a substantial proportion of patients who achieve a good clinical response to treatment or remission. This paradoxical observation has not been thoroughly explored in SLE.Objectives:To determine the prevalence of adverse HRQoL outcomes in patients with SLE who achieved an adequate clinical response after a 52-week long period on standard therapy plus belimumab or placebo, within the frame of two phase III clinical trials. We further aimed to compare frequencies of adverse HRQoL outcomes across different age categories and ethnic groups, and sought to identify contributing factors.Methods:We included patients who met the primary endpoint of the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (N=760/1684), i.e. attainment of the SLE Responder Index 4 at week 52. Accordingly, evaluation of adverse HRQoL outcomes was based on patient reports at week 52 from treatment initiation, using the Medical Outcomes Study Short Form 36 (SF-36) health survey and the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue) scale. Adverse HRQoL outcomes were defined as (i) SF-36 scale scores ≤ the 5th percentile derived from age- and sex-matched US population-based norms from the SF-36 health survey user manual; and (ii) FACIT-Fatigue scores <30.Pearson’s chi-square or Fisher’s exact tests were used to investigate associations between dichotomous variables. Comparisons of continuous data between SLE patients and age- and sex-matched norms were performed using the Wilcoxon signed-rank test. Multivariable logistic regression models were created in order to assess independence and priority of potential factors associated with adverse HRQoL outcomes.Results:We found clinically important diminutions of HRQoL in SLE patients compared with matched norms and high frequencies of adverse HRQoL outcomes, the highest in SF-36 general health (29.1%), followed by FACIT-Fatigue (25.8%) and SF-36 physical functioning (25.4%). Overall, frequencies were higher with increasing age. Black/African American and White/Caucasian patients reported higher frequencies than Asians and Indigenous Americans, while Hispanics experienced adverse HRQoL less frequently than non-Hispanics. Increasing organ damage was associated with adverse physical but not mental HRQoL outcomes; disease activity showed no impact. In multivariable logistic regression analysis, addition of belimumab to standard therapy was associated with lower frequencies of adverse SF-36 physical functioning (OR: 0.59; 95% CI: 0.39–0.91; P=0.016) and FACIT-F (OR: 0.53; 95% CI: 0.34–0.81; P=0.004).Conclusion:Substantial proportions of SLE patients reported adverse HRQoL outcomes despite adequate clinical response to treatment, especially in physical aspects. Particularly high proportions were seen within Black/African American and White/Caucasian patients. Add-on belimumab may be protective against adverse physical functioning and severe fatigue. Our results corroborate that HRQoL diminutions constitute a substantial burden in patients with SLE, and highlight the limitations of current therapeutic strategies.Acknowledgements:The authors would like to thank GlaxoSmithKline (Uxbridge, UK) for sharing the data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials with the Clinical Study Data Request (CSDR) consortium, Dimitris Ladakis, Joaquin Matilla and Martin Pehr for contributing to the management of data, as well as all participating patients.Disclosure of Interests:Alvaro Gomez: None declared, Julius Lindblom: None declared, Victor Qiu: None declared, Arvid Cederlund: None declared, Alexander Borg: None declared, Sharzad Emamikia: None declared, Yvonne Enman: None declared, Jon Lampa: None declared, Ioannis Parodis Grant/research support from: Research funding and/or honoraria from Amgen, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline and Novartis.
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Doi, Hiroshi, Koichiro Ohmura, Yuya Tabuchi, Motomu Hashimoto, Yudai Takase, Ryuta Inaba, Tomohiro Kozuki et al. "Validation and verification of the Japanese version of the systemic lupus erythematosus symptom checklist for patient quality of life". Lupus 30, n. 7 (28 marzo 2021): 1108–15. http://dx.doi.org/10.1177/09612033211005026.
Testo completoAbstract (sommario):
Objective The systemic lupus erythematosus (SLE) symptom checklist (SSC) is a patient-reported outcome measure consisting of 38 queries. We translated SSC into Japanese and attempted to validate its usefulness for evaluating the quality of life (QOL) of SLE patients and identify factors that affect QOL. Methods Data from the Medical Outcomes Study Short-form 36 questionnaire (SF-36), Japanese LupusPRO, the Japanese version of the SSC (SSC-J) questionnaire, SLEDAI-2k, and the physician global assessment (PGA) were obtained on the same day from 226 SLE outpatients of the Kyoto Lupus cohort at Kyoto University Hospital. Relationships between the total scores or each item of SSC-J and SF-36, Japanese LupusPRO, SLEDAI-2k, or PGA were analyzed by Spearman’s rank test. Results The total scores of SSC-J correlated with the scores of SF-36 and Japanese LupusPRO. In each item of SSC-J, all 38 items correlated with the physical component summary and mental component summary of SF-36 as well as the Health-Related QOL (HRQOL) scores of Japanese LupusPRO, but not with the non-HRQOL of LupusPRO. SSC-J scores correlated with age, PGA, and corticosteroid doses, but not with SLEDAI-2k. Conclusions SSC-J is suitable as a disease-specific QOL assessment tool for SLE.
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Ugarte-Gil, Manuel Francisco, Rocio Violeta Gamboa-Cardenas, Cristina Reátegui-Sokolova, Victor Román Pimentel-Quiroz, Mariela Medina, Claudia Elera-Fitzcarrald, Zoila Rodriguez-Bellido, Cesar Augusto Pastor-Asurza, Risto Alfredo Perich-Campos e Graciela S. Alarcón. "A better self-efficacy is predictive of better health-related quality of life (HRQoL) in patients with systemic lupus erythematosus: data from the Almenara Lupus Cohort". Lupus Science & Medicine 10, n. 1 (febbraio 2023): e000874. http://dx.doi.org/10.1136/lupus-2022-000874.
Testo completoAbstract (sommario):
ObjectiveTo determine the possible predictive value of self-efficacy on health-related quality of life (HRQoL) in patients with SLE.MethodsPatients with SLE from the Almenara Lupus Cohort were included. Self-efficacy was ascertained with the six domains from the Patient-Reported Outcomes Measurement Information System (PROMIS) self-efficacy for managing chronic conditions. For PROMIS domains, a score of 50 is the average for a clinical population (people with a chronic condition), a higher score indicates that the respondent has greater self-efficacy. HRQoL was ascertained with the physical and mental component summary (PCS and MCS) measures of the Short-Form 36 (SF-36). Generalised estimating equations were performed, using as outcome the PCS or MCS in the subsequent visit, and the self-efficacy domain in the previous visit; multivariable models were adjusted for possible confounders. The confounders were measured in the same visit as the self-efficacy domain.ResultsTwo-hundred and nine patients for a total of 564 visits were included; 194 (92.8%) patients were women and mean age at diagnosis was 36.4 (14.0) years. In the multivariable models, a better PCS was predicted by a better self-efficacy for managing symptoms, managing medications and treatments and managing social interactions and general self-efficacy; a better MCS was predicted by a better self-efficacy for managing daily activities, managing symptoms, managing medications and treatments and managing social interactions.ConclusionA better self-efficacy is predictive of subsequent better HRQoL, even after adjustment for possible confounders. These results should encourage clinicians to develop strategies to improve self-efficacy in patients with SLE.
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Corzo Garcia, P., I. Carrión Barberà, I. Garcia-Duitama, A. Agustí Claramunt, S. Marsico, J. Monfort e T. C. Salman Monte. "AB0491 MUSCULOSKELETAL INVOLVEMENT, CONFIRMED BY CONTRAST ENHANCED MRI, CONTRIBUTES TO A WORSE HEALTH-RELATED QUALITY OF LIFE IN SLE PATIENTS". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 1372.2–1372. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1923.
Testo completoAbstract (sommario):
BackgroundJoint involvement in SLE is the most frequent manifestation, despite this, its impact on health-related quality of life (HRQoL) has not been well stablished in these patients1. Pain, fatigue and functional disability contribute to HRQoL related to SLE2.ObjectivesWe aim to study the relation between joint and tendon involvement confirmed by contrasted MRI and these patient related outcomes (PRO).MethodsConsecutive SLE patients fulfilling SLICC criteria both symptomatic and asymptomatic for joint involvement were recruited. Gadolinium-enhanced MRI of non-dominant hand/wrist was performed in all subjects for joint and tendon evaluation. Different PRO: numeric scale (NE) of pain (0-10) and fatigue (0-3), Health Assessment Questionnaire (HAQ) and Fatigue Severity Scale (FSS-9) were collected and statistically analysed along with each MRI abnormality.Results83 subjects were recruited. Patients with synovitis, tenosynovitis, peritendonitis and bone marrow edema reported higher values in pain NE (6.03±2.57 vs 4.26±2.49, p 0.005; 6.56±1.95 vs 4.76±2.75, p 0.017; 8.80±1.30 vs 4.95±2.55, p 0.001; 6.47±2.62 vs 4.83±2.58, p 0.026); patients with synovitis reported higher values in fatigue EN (2.32±0.82 vs 1.91±0.84, p 0.035) and patients with tenosynovitis showed worse FSS-9 (61.50±1.73 vs 45.70±16.80, p 0.015) versus patients who did not show these abnormalities by MRI. Patients with synovitis and peritendonitis had a worse HAQ (1.14±0.69 vs 0.75±0.65, p 0.031; 1.69±0.07 vs 0.90±0.69, p 0.018).ConclusionSLE patients with joint and/or tendon involvement confirmed by contrast enhanced MRI have a worse HRQoL measured by pain, fatigue and functional disability.References[1]Ceccarelli F et al. Joint involvement in systemic lupus erythematosus: From pathogenesis to clinical assessment. Semin Arthritis Rheum. 2017;47:53-64[2]Piga M et al. Musculoskeletal manifestations as determinants of quality of life impairment in patients with systemic lupus erythematosus. Lupus. 2018 Feb;27(2):190-198AcknowledgementsGSK and societat Catalana de Reumatologia granted this work and we acknowledge them for their collaborationDisclosure of InterestsPATRICIA CORZO GARCIA Grant/research support from: GSK, Irene Carrión Barberà: None declared, Ivan Garcia-Duitama: None declared, Anna Agustí Claramunt: None declared, Salvatore Marsico: None declared, Jordi Monfort Grant/research support from: GSK, Tarek Carlos Salman Monte Grant/research support from: GSK
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Skoglund, Oliver, Tomas Walhelm, Ingrid Thyberg, Per Eriksson e Christopher Sjöwall. "Fighting Fatigue in Systemic Lupus Erythematosus: Experience of Dehydroepiandrosterone on Clinical Parameters and Patient-Reported Outcomes". Journal of Clinical Medicine 11, n. 18 (8 settembre 2022): 5300. http://dx.doi.org/10.3390/jcm11185300.
Testo completoAbstract (sommario):
Manifestations related to ongoing inflammation in systemic lupus erythematosus (SLE) are often adequately managed, but patient-reported outcome measures (PROMs) support that fatigue and low quality of life (QoL) in the absence of raised disease activity remain major burdens. The adrenal hormone dehydroepiandrosterone (DHEA) has shown potential as a pharmacological agent for managing fatigue in mild SLE. We retrospectively evaluated data on dosage, disease activity, corticosteroid doses, concomitant antirheumatic drugs, and PROMs regarding pain intensity, fatigue, and well-being (visual analogue scales), QoL (EQ-5D-3L) and functional disability. A total of 15 patients with SLE were exposed to DHEA and 15 sex- and age-matched non-exposed SLE patients served as comparators. At baseline, 83% of the DHEA-exposed patients had subnormal DHEA concentration. The 15 subjects prescribed DHEA were exposed during a median time of 12 months (IQR 16.5) [range 3–81] and used a median daily dose of 50 mg of DHEA (IQR 25.0) [range 25–200]. Neither disease activity, nor damage accrual, changed significantly over time among patients using DHEA, and no severe adverse events were observed. Numerical improvements of all evaluated PROMs were seen in the DHEA-treated group, but none reached statistical significance. For DHEA-exposed patients, a non-significant trend was found regarding fatigue comparing baseline and 36 months (p = 0.068). In relation to SLE controls, the DHEA-exposed group initially reported significantly worse fatigue, pain, and well-being, but the differences diminished over time. In conclusion, DHEA was safe, but evidence for efficacy of DHEA supplementation in relation to PROMs were not found. Still, certain individuals with mild SLE, plagued by fatigue and absence of increased disease activity, appear to benefit from DHEA in terms of improved fatigue and QoL. Testing of DHEA concentration in blood should be performed before initiation, and investigation of other conditions, or reasons responsible for fatigue, must always be considered first.
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Pinto, B., M. Jolly, A. Dhooria, S. Grover, J. M. Raj, H. Devilliers e A. Sharma. "Hindi LupusPRO: cross cultural validation of disease specific patient reported outcome measure of lupus". Lupus 28, n. 13 (21 ottobre 2019): 1534–40. http://dx.doi.org/10.1177/0961203319880340.
Testo completoAbstract (sommario):
Background LupusPRO is a SLE specific patient reported outcomes measure developed and validated in the USA. This study aimed to validate the Hindi version of LupusPRO in systemic lupus erythematosus (SLE) patients in India. Methods Disease activity and damage were assessed using SELENA–SLEDAI and SLICC/ACR damage Index respectively. Demographic and clinical features were recorded. The Hindi Version of LupusPRO and 36-Item Short Form Health Survey (SF-36) were administered for assessment of quality of life. Depression, anxiety and fatigue were assessed using Patient Health Questionnaire 9 (PHQ9), Generalized Anxiety Disorder 7 (GAD7) and Fatigue Severity Scale (FSS) respectively. Internal consistency reliability, test-retest reliability, convergent and discriminant validity (against corresponding domains of the SF-36, fatigue, depression and anxiety), criterion validity (against disease activity and damage) and known group validity were tested. Results A total of 144 (140 females) patients with SLE with a mean age of 32.48 ± 7.26 years participated in the study. The median (interquartile range) SELENA SLEDAI was 2 (5.5). The internal consistency reliability of the LupusPRO domains was >0.7 for most domains (except for lupus symptoms, lupus medication, procreation and social support).We noted good convergent validity of LupusPRO domains with corresponding domains of SF-36, pain vitality with fatigue (FSS) and emotional health domain with depression (PHQ9) and anxiety (GAD7). Criterion validity of lupus symptoms with disease activity was observed. Known group validity of the LupusPRO domains with patient reported health status was observed. Confirmatory factor analysis showed a good fit. Conclusion The Hindi LupusPRO has fair psychometric properties among Indian patients with SLE.
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Kernder, Anna, Christina Düsing, Jutta Richter, Ralph Brinks, Rebecca Fischer-Betz, Borgi Winkler-Rohlfing, Martin Aringer, Matthias Schneider e Gamal Chehab. "Factors detrimental to work productivity and daily activities in systemic lupus erythematosus patients – Analysis of the German LuLa study". Lupus 30, n. 12 (ottobre 2021): 1931–37. http://dx.doi.org/10.1177/09612033211045063.
Testo completoAbstract (sommario):
Objective The aim of this study was to identify factors associated with impaired work productivity and impaired daily activities in patients with systemic lupus erythematosus (SLE). Methods The LuLa study is a longitudinal patient-reported study. Beyond sociodemographic data, work productivity, daily activities and fatigue, several other clinical outcome parameters (e.g. mental health–related quality of life and physical functioning, disease activity, damage and pain) were surveyed with validated questionnaires. The effects of confounders on work productivity (WPAI 2) and daily activity domains (WPAI 4) were studied by multivariate regression analysis. Results A total of 585 patients completed the questionnaire of whom 259 were employed and analysed. The median impairment in work productivity (WPAI 2) was 20% (Q1–3 0–40), and the median impairment in daily activities (WPAI 4) was 30% (Q1–3 10–50%). Multivariate regression analysis revealed that fatigue, pain, disease activity and health-related quality of life affected WPAI 2 and 4. Furthermore, we observed distinct synergistic effects of fatigue, disease activity and pain on both work productivity and daily activities: a higher impact of fatigue was associated with the reported extent of pain or disease activity. Conclusion In employed patients with SLE, impaired work productivity and impaired daily activities were frequently reported. Fatigue, pain, disease activity and health-related quality of life demonstrated a detrimental impact, with a synergistic effect of fatigue, disease activity and pain. Hence, both optimized pain management and targeted immunomodulatory therapy are important for preserving active participation in life among patients with fatigue.
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Cintrón, D., J. M. Alanis, N. Álvarez-Villalobos, R. Rodríguez-Gutiérrez e L. M. Vilá. "A systematic review of pharmacological therapies and their effectiveness on health-related quality of life outcomes in patients with juvenile-onset systemic lupus erythematosus". Lupus 29, n. 3 (7 febbraio 2020): 303–10. http://dx.doi.org/10.1177/0961203320904145.
Testo completoAbstract (sommario):
Juvenile-onset systemic lupus erythematosus (JSLE) presents with an aggressive course and high morbidity associated with disease and treatment. JSLE patients have a poorer health-related quality of life (HRQoL) when compared with age-matched patients with other rheumatologic disorders. We aim to summarize the impact of current pharmacological therapies on the HRQoL of JSLE patients. Search strategies were developed across seven databases. Randomized clinical trials (RCTs) and cohort studies comparing interventions to standard therapy, placebo or pre-post cohort comparisons for more than 4 weeks were included. The outcome included self-reported scales compared at baseline and a therapeutic time point. Risk of bias was evaluated by using the Cochrane risk of bias tool and the Newcastle–Ottawa quality assessment scale. A total of 2812 articles were narrowed down to 309 for full-text screening. Four RCTs and one prospective cohort study, with a total of 634 JSLE patients, met the inclusion criteria. Four of the studies had a controlled intervention plus standard therapy compared with standard therapy alone or placebo. Multiple indices were used to evaluate HRQoL. These included the Pediatric Quality of Life Inventory, Childhood Health Assessment Questionnaire, Simple Measure of Impact of Lupus Erythematosus in Youngsters tool, Kids Fatigue Severity Scale and Child Depression Inventory. A single study reported a significant improvement while remaining studies reported no difference or failed to report the statistical analysis. Although HRQoL is significantly impaired in JSLE, evidence regarding its improvement is limited due to the small number of eligible studies, heterogeneity in scales, and HRQoL domains. A universal HRQoL questionnaire for JSLE needs to be established and used in both the research and clinical setting. All studies should adhere to reporting guidelines.
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Antony, A., R. K. Kandane-Rathnayake, T. Ko, D. Boulos, A. Y. Hoi, M. Jolly e E. F. Morand. "Validation of the Lupus Impact Tracker in an Australian patient cohort". Lupus 26, n. 1 (20 agosto 2016): 98–105. http://dx.doi.org/10.1177/0961203316664593.
Testo completoAbstract (sommario):
Objectives The objective of this article is to validate the Lupus Impact Tracker (LIT), a disease-specific patient-reported outcome (PRO) tool, in systemic lupus erythematosus (SLE) patients in a multi-ethnic Australian cohort. Methods Patients attending the Monash Lupus Clinic were asked to complete the LIT, a 10-item PRO. Psychometric testing assessing criterion validity, construct validity, test-retest reliability (TRT) and internal consistency reliability (ICR) were performed. We compared the LIT scores across patient characteristics, and correlations between LIT scores and SLEDAI-2k, PGA, and SLICC-SDI were examined. Results LIT data were obtained from 73 patients. Patients were 84% female with a median age of 41 years, and 34% were Asian. The cohort had mild-moderate disease activity with a median (IQR) Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2k) of 4 (IQR 2–6). The median LIT score was 32.5 (IQR 17.5–50). LIT demonstrated criterion validity against SLEDAI-2k and SDI. Construct validity assessed by confirmatory factor analysis demonstrated an excellent fit (Goodness of fit index 0.95, Comparative Fit Index 1, Root Mean Square Error of Approximation <0.0001). The LIT demonstrated TRT with an overall intraclass correlation coefficient of 0.986 (95% CI 0.968–0.995). ICR was demonstrated with a Cronbach’s alpha of 0.838. Patients with disability, low socioeconomic status, or higher disease activity had significantly worse LIT scores. Conclusion The LIT demonstrated properties consistent with its being valid in this population. Lower socioeconomic status appears to have a significant impact on patient-reported health-related quality of life in SLE.
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Martínez-Rosales, Elena, Sergio Sola-Rodríguez, José Antonio Vargas-Hitos, Blanca Gavilán-Carrera, Antonio Rosales-Castillo, Alba Hernández-Martínez, Enrique G. Artero, José Mario Sabio e Alberto Soriano-Maldonado. "Heart Rate Variability in Women with Systemic Lupus Erythematosus: Association with Health-Related Parameters and Effects of Aerobic Exercise". International Journal of Environmental Research and Public Health 17, n. 24 (18 dicembre 2020): 9501. http://dx.doi.org/10.3390/ijerph17249501.
Testo completoAbstract (sommario):
Abnormal heart rate variability (HRV) has been observed in patients with systemic lupus erythematosus (SLE). In a combined cross-sectional and interventional study approach, we investigated the association of HRV with inflammation and oxidative stress markers, patient-reported outcomes, and the effect of 12 weeks of aerobic exercise in HRV. Fifty-five women with SLE (mean age 43.5 ± 14.0 years) were assigned to either aerobic exercise (n = 26) or usual care (n = 29) in a non-randomized trial. HRV was assessed using a heart rate monitor during 10 min, inflammatory and oxidative stress markers were obtained, psychological stress (Perceived Stress Scale), sleep quality (Pittsburg Sleep Quality Index), fatigue (Multidimensional Fatigue Inventory), depressive symptoms (Beck Depression Inventory), and quality of life (36-item Short-Form Health Survey) were also assessed. Low frequency to high frequency power (LFHF) ratio was associated with physical fatigue (p = 0.019). Sample entropy was inversely associated with high-sensitivity C-reactive protein (p = 0.014) and myeloperoxidase (p = 0.007). There were no significant between-group differences in the changes in HRV derived parameters after the exercise intervention. High-sensitivity C-reactive protein and myeloperoxidase were negatively related to sample entropy and physical fatigue was positively related to LFHF ratio. However, an exercise intervention of 12 weeks of aerobic training did not produce any changes in HRV derived parameters in women with SLE in comparison to a control group.
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Grabich, Shannon, Eileen Farrelly, Robert Ortmann, Michael Pollack e Sandra Sze-jung Wu. "Real-world burden of systemic lupus erythematosus in the USA: a comparative cohort study from the Medical Expenditure Panel Survey (MEPS) 2016–2018". Lupus Science & Medicine 9, n. 1 (maggio 2022): e000640. http://dx.doi.org/10.1136/lupus-2021-000640.
Testo completoAbstract (sommario):
ObjectiveSLE is a chronic, multiorgan, autoimmune disease; however, current prevalence estimates are dated and often from non-generalisable patient populations, and quality of life and patient-reported outcomes in the real-world SLE population are not well-published. The present study used the Medical Expenditure Panel Survey (MEPS), a generalisable US data source encompassing a representative sample of regions/payers, to estimate SLE prevalence and characterise disease burden compared with non-SLE respondents.MethodsRetrospective population-based survey data weighted to the full US population from MEPS for the calendar years 2016–2018, pooled over the full study period, was used. The primary inclusion criteria included adults with self-reported SLE and either a record of SLE-related medication and/or rheumatologist visit in the calendar year. A matched-control cohort was created and the general non-SLE MEPS population was matched to MEPS SLE respondents by gender, age, region and MEPS reporting year using a 1:5 ratio.ResultsFrom 2016 to 2018, 96 996 adults reported annual data in MEPS, of whom 154 respondents met the primary SLE definition, equivalent to 490 385 weighted number of adults with SLE. The prevalence of SLE was 195 (95% CI 149 to 242) per 100000, with greater prevalence observed in the US South, African-American/black and publicly insured people and females. SLE respondents reported limitations in physical function at 3 times greater rate (45% vs 15%; p<0.0001), higher rates of pain-limiting work (67% vs 39%; p<0.001) and feeling depressed ‘nearly every day’ (7% vs 2%; p<0.001) compared with non-SLE respondents. All-cause healthcare and prescription expenses were significantly higher in SLE respondents (US$17 270 vs US$8350 (p<0.0001) and US$4512 vs US$1952 (p<0.001), respectively, in 2018 US dollars).ConclusionWide variation of SLE prevalence exists among patients of different regional, demographic and payer groups; SLE is associated with adverse quality of life, productivity and economic outcomes compared with non-SLE respondents.
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AGGARWAL, ROHIT, CAITLYN T. WILKE, A. SIMON PICKARD, VIKRANT VATS, RACHEL MIKOLAITIS, LEWIS FOGG, JOEL A. BLOCK e MEENAKSHI JOLLY. "Psychometric Properties of the EuroQol-5D and Short Form-6D in Patients with Systemic Lupus Erythematosus". Journal of Rheumatology 36, n. 6 (15 aprile 2009): 1209–16. http://dx.doi.org/10.3899/jrheum.081022.
Testo completoAbstract (sommario):
Objective.Health related quality of life (HRQOL) is an important patient-reported outcome in systemic lupus erythematosus (SLE). We evaluated the psychometric properties of 2 widely used preference-based generic HRQOL measures, EuroQol-5D (EQ-5D) and Short Form-6D (SF-6D), among United States patients with SLE.Methods.Patients with SLE enrolled at an academic institution were assessed for self-reported generic HRQOL (EQ-5D, Medical Outcomes Study SF-36), disease activity, and disease damage SF-6D. Physical Component Score (PCS) and Mental Component Score (MCS) were calculated from SF-36. Criterion validity, convergent validity, and known-groups comparisons were evaluated for EQ-5D and SF-6D. Sensitivity to change (t tests, effect size) was evaluated in a subset of the cohort followed longitudinally.Results.One hundred sixty-seven patients with SLE were enrolled. Related domains on the EQ-5D and SF-36 correlated strongly, e.g., mobility and physical functioning (r = 0.60), whereas unrelated domains showed weak to moderate correlation. EQ-5D index, EQ-5D visual analog scale, and SF-6D score correlated strongly among each other as well as with most domains of SF-36. Both EQ-5D and SF-6D indices differentiated among patients of varied disease severity. EQ-5D and SF-6D were found to be sensitive to self-reported change in health but insensitive to change in disease activity longitudinally. Disease activity and damage showed weak correlation with HRQOL measures.Conclusion.The SF-6D and EQ-5D exhibited satisfactory psychometric properties for use among US patients with SLE. Measures of disease activity and damage were weakly correlated with HRQOL, suggesting that HRQOL is an important complementary source of information about patients with SLE.
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Gomez, A., F. H. Butrus, P. Johansson, E. Åkerström, S. Soukka, S. Emamikia, Y. Enman, S. Pettersson e I. Parodis. "FRI0168 ASSOCIATION OF OVERWEIGHT/OBESITY WITH IMPAIRED HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 668–69. http://dx.doi.org/10.1136/annrheumdis-2020-eular.4016.
Testo completoAbstract (sommario):
Background:Patients with systemic lupus erythematosus (SLE) experience a considerably impaired health-related quality of life (HRQoL) compared with the general population. Previous literature has implied an association between high body mass index (BMI) and HRQoL diminutions. However, data are scarce and further exploration in large study populations and, importantly, with regard to the clinical significance of this association is needed.Objectives:The aim of this study was to determine whether overweight and/or obesity were associated with impaired physical and/or mental HRQoL aspects in the SLE population of two large clinical trials.Methods:We utilised pooled baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) clinical trials of belimumab (N=1684). Access to data was granted by GlaxoSmithKline. The patients were stratified into four groups based on their body mass index (BMI), according to WHO guidelines. We conducted comparisons between non-overweight versus overweight, and non-obese versus obese SLE patients. HRQoL was self-reported using the Medical Outcomes Study (MOS) short form 36 (SF-36) health survey, the functional assessment of chronic illness therapy (FACIT)-Fatigue scale and the three-level EuroQol- 5 Dimension (EQ-5D) questionnaire. We explored whether the differences in scores were clinically meaningful using previously determined thresholds for minimal clinically important differences (MCIDs). The non-parametric Mann-Whitney U test was used for comparisons between different BMI groups. Linear regression analysis was next applied to test independence in multivariable models, adjusting for age, sex, ethnicity, disease duration, disease activity, organ damage and standard of care treatment.Results:Forty-four per cent (44%) of the patients had a BMI score over the normal range, and 18% were obese. The overweight group performed worse than the non-overweight with regard to FACIT-Fatigue scores (mean ± standard deviation: 27.7 ± 12.1 vs 32.0 ± 11.3; P<0.001), EQ-5D score (0.70 ± 0.19 vs 0.76 ± 0.18; P<0.001) and all SF-36 subscales and component summaries. The differences were greater than the MCIDs for physical component summary (PCS) scores (36.9 ± 9.3 vs 40.8 ± 9.6; P<0.001), physical functioning (53.3 ± 25.1 vs 63.6 ± 25-1; P<0.001), role physical (48.0 ± 27.1 vs 55.6 ± 26.9; P<0.001), bodily pain (43.8 ± 22.4 vs 52.5 ± 25.1; P<0.001), vitality (39.6 ± 21.7 vs 46.6 ± 21.3; P<0.001), and social functioning scores (55.8 ± 25.2 vs 62.6 ± 25.2; P<0.001). Likewise, obese patients reported worse FACIT-Fatigue scores (25.7 ± 11.9 vs 31.1 ± 11.6; P<0.001), EQ-5D scores (0.68 ± 0.20 vs 0.75 ± 0.18; P<0.001) and clinically important diminutions of HRQoL in all SF-36 items, except for the mental component summary (MCS), role emotional and mental health.In multivariable linear regression analysis, the overweight and obese group showed worse PCS scores (standardised coefficient: β=-0.09; P<0.001 and β=-0.13; P<0.001, respectively) and FACIT-Fatigue scores (β=-0.11; P<0.001 and β=-0.10; P<0.001, respectively), and overweight patients had significantly impaired MCS scores (β=-0.05; P=0.039), irrespective of other factors. High disease activity and organ damage were associated with impaired HRQoL in all aspects, while Asian patients reported better PCS scores (and β=0.29; P=0.007) and FACIT-Fatigue scores (β=0.33; P=0.002).Conclusion:BMI above normal was highly associated with HRQoL impairment, especially in physical aspects. Further survey to examine causality is warranted to support structured weight control strategies as an intervention towards a more favourable HRQoL.Disclosure of Interests:None declared
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Hanly, J. G., M. B. Urowitz, D. Jackson, S. C. Bae, C. Gordon, D. J. Wallace, A. Clarke et al. "SF-36 summary and subscale scores are reliable outcomes of neuropsychiatric events in systemic lupus erythematosus". Annals of the Rheumatic Diseases 70, n. 6 (21 febbraio 2011): 961–67. http://dx.doi.org/10.1136/ard.2010.138792.
Testo completoAbstract (sommario):
ObjectiveTo examine change in health-related quality of life in association with clinical outcomes of neuropsychiatric events in systemic lupus erythematosus (SLE).MethodsAn international study evaluated newly diagnosed SLE patients for neuropsychiatric events attributed to SLE and non-SLE causes. The outcome of events was determined by a physician-completed seven-point scale and compared with patient-completed Short Form 36 (SF-36) health survey questionnaires. Statistical analysis used linear mixed-effects regression models with patient-specific random effects.Results274 patients (92% female; 68% Caucasian), from a cohort of 1400, had one or more neuropsychiatric event in which the interval between assessments was 12.3±2 months. The overall difference in change between visits in mental component summary (MCS) scores of the SF-36 was significant (p<0.0001) following adjustments for gender, ethnicity, centre and previous score. A consistent improvement in neuropsychiatric status (N=295) was associated with an increase in the mean (SD) adjusted MCS score of 3.66 (0.89) in SF-36 scores. Between paired visits when the neuropsychiatric status consistently deteriorated (N=30), the adjusted MCS score decreased by 4.00 (1.96). For the physical component summary scores the corresponding changes were +1.73 (0.71) and −0.62 (1.58) (p<0.05), respectively. Changes in SF-36 subscales were in the same direction (p<0.05; with the exception of role physical). Sensitivity analyses confirmed these findings. Adjustment for age, education, medications, SLE disease activity, organ damage, disease duration, attribution and characteristics of neuropsychiatric events did not substantially alter the results.ConclusionChanges in SF-36 summary and subscale scores, in particular those related to mental health, are strongly associated with the clinical outcome of neuropsychiatric events in SLE patients.
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Elefante, E., C. Tani, V. Signorini, C. Stagnaro, D. Zucchi, F. Trentin, L. Carli, F. Ferro e M. Mosca. "POS0753 PROSPECTIVE EVALUATION OF HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN A MONOCENTRIC COHORT OF PATIENTS WITH LONGSTANDING SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 662. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2708.
Testo completoAbstract (sommario):
BackgroundThe optimization of HRQoL in SLE patients is defined as one of the treatment goals in the 2019 EULAR recommendations1 for the management of SLE. Most studies have examined HRQoL at one point in time, while the few longitudinal studies do not report a clear variation in Patient Reported Outcomes (PROs) with respect to changes in disease activity. It would be important to understand if, even in a real-life setting, the improvement of patients’ HRQoL may represent an achievable target.Objectivesthe aim of this study was to analyze HRQoL over time in a monocentric cohort of patients with SLE and investigate which disease-related factors determine short-term variation of HRQoL in a real-life setting.Methodsthis is a longitudinal, prospective monocentric study which included consecutive adult outpatients with SLE (1997 ACR classification criteria), regularly followed at the Rheumatology Unit of Pisa. Patients were enrolled over a period of 2 years, before the pandemic outbreak, and had at least 2 assessments per year. For each patient, demographics, comorbidities, treatment, clinical and laboratory data were collected. Disease activity was evaluated with the SELENA-SLEDAI and organ damage with the SLICC/DI. We defined as a significant variation of disease activity, a difference of clinical SELENA-SLEDAI ≥ 4 points between 2 subsequent evaluations. At each visit, patients completed the following PROs: SF-36, FACIT-Fatigue and LIT.Resultswe enrolled 210 consecutive SLE patients, mainly female (93.8%) and of Caucasian ethnicity (97.1%), with a mean age at enrollment of 45.1±12.7 years and a median disease duration of 13 years (IQR 5-21). At baseline, the median SLEDAI of the cohort was 2 (IQR 0-4). The most frequent active disease manifestations were: articular (17.1%) and hematological (15.2%); 6.7% of patients had active renal disease. 47.14% had a SLICC-DI > 0 with a median SLICC-DI among them of 2 (IQR 1-3). 11.43% of patients had a concomitant fibromyalgia. Most patients were on Hydroxychloroquine (78.1%) and low dose glucocorticoid (55.2%), with a median daily dose of 2 mg (IQR 0-4) of prednisone equivalent; 41.4% were on conventional immunosuppressants and 11.9% on biologics, mainly belimumab. The median scores of PROs at enrollment are reported in Table 1. At baseline, fibromyalgia confirmed to have a significant negative impact on all PROs after adjustment for confounding factors (p<0.05). Each patient underwent two consecutive evaluations, with a median interval between them of 11.4 months. We observed a significant variation of disease activity in 36/210 patients (17.14%). Then, we compared the subgroup of patients with unchanged disease activity with that of patients who showed a significant variation of disease activity. We found that FACIT and LIT scores didn’t change over time in both subgroups, whereas PCS (p<0.001) and MCS (p<0.01) scores of the SF-36 showed a significant variation in both groups, between the first and the second clinical assessment. However, in the subgroup of patients with a significant change of disease activity, the variation of PCS and MCS was not correlated with the variation of disease activity or ongoing treatment. In particular, patients with a significant improvement of HRQoL over time didn’t have a corresponding significant reduction of the SLEDAI score or of the daily glucocorticoid dose.Table 1.PROs scores at baseline.PROsMedian scores at baselineSF-36 PCS58 (IQR 49.09- 68)SF-36 MCS57 (IQR 46.42-67)FACIT42 (IQR 32-46)LIT20 (IQR 7.5-40)Conclusionour findings seem to suggest that HRQoL over time in outpatients with longstanding SLE tends to be stable (maybe because patients are able to adapt to their illness) or varies unpredictably, maybe influenced by not disease-related factors. Further studies are needed to better understand which factors influence HRQoL over time and which questionnaires are more sensitive to catch its variation.References[1]PMID: 30926722Disclosure of InterestsNone declared
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Ardhaoui, M., M. Brahem, S. Arfa, B. Ben Rejeb, M. Hassayoun, R. Sarraj, H. Hachfi, O. Berriche e Y. Mohamed. "AB0526 ASSESSMENT OF HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS USING SF-36 SCALE". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 1391.1–1391. http://dx.doi.org/10.1136/annrheumdis-2022-eular.3629.
Testo completoAbstract (sommario):
BackgroundSystemic Lupus Erythematosus (SLE) has diverse effects on patients' health-related quality-of-life (HRQoL), affecting both physical and mental domains of well-being. The Medical Outcomes Survey 36-item Short Form (SF-36) is one of the most common generic instruments used to measure HRQoL in SLE.ObjectivesOur objective in this study is to assess the aspects of HRQoL in patients with SLE and to explore the associations between HRQoL and disease-related parameters.MethodsA cross-sectional study was conducted in patients followed in the departments of Internal Medicine and Rheumatology in Mahdia, Tunisia, who met either the 1997 ACR or the 2012 SLICC criteria for SLE. We evaluated for each patient, the global score and the eight domains of SF-36 (physical functioning (PF), role physical (RP), bodily pain (BP) and general health (GH) gathered into the Physical Component Summary (PCS); vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH)) gathered into Mental component Summary (MCS), scored from 0 (worst) to 100 (best). The disease activity was evaluated by the SLE Disease Activity Index (SLEDAI).ResultsForty SLE patients were enrolled. 90% of patients were female. The mean age was 47.75±17.59 years. The mean disease duration was 2.3±2.9 years. The mean SLEDAI was 5.78±4.94. The most commonly found manifestations of SLE were; cutaneous, musculoskeletal and neuro-psychiatric in 85%, 82.5% and 40% of cases, respectively. The anti-nuclear antibodies were positive in 100% of cases. Serum levels of complement C3 and C4 were low in 20% and 32.5% of cases, respectively. A biological inflammatory syndrome was found in 37.5% of cases and anemia in 42.5% of cases. Anti-malarial were prescribed for 85% of patients, Glucocortoids were prescribed for 62.5% of patients. The SF-36 global score was 60.5 ± 20.5 ranging from 18.5 to 93.1. Eighteen patients (45 %) had impaired HRQoL (SF-36 < 66.7). The physical domains were more affected than the mental ones with mean scores of PCS and MCS of 59.59 and 61.6, respectively. The means of different domains (PF, RP, BP, GH, VT, SF, RE and MH) were respectively 67.87±28.3; 52.5±50; 62.5±29; 55.49±25.6; 56±21.5; 64±25.7; 67.5 ±47.4 and 58.6±18.6. The most severely impacted domains were RP and GH. Increased age was correlated with reduced PF, BP and PCS (p=0.02, p=0.02, p=0.05 respectively). Longer disease duration was associated with reduced GH (p=0.004). The analysis of organ-specific damage revealed that musculoskeletal involvement was significantly associated with lower scores of PF, RP, BP and PCS (p=0.05, p=0.009, p=0.01 and p<0.001, respectively), While neurological involvement was associated with lower scores of SF, VT and MCS (p=0.01, p=0.05 and p=0.04, respectively). The SF-36 global score and its domains had no significant correlations with the SLEDAI, the biological abnormalities or the received treatments.ConclusionImpairment in the quality of life can be significant when suffering from SLE, affecting physical health more than mental health according to our study. HRQoL should be included in routine clinical care in SLE patients.Disclosure of InterestsNone declared
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Collacott, H., A. Phillips-Beyer, N. Krucien, K. Marsh e B. Flamion. "POS0086-PARE PATIENT PREFERENCES FOR SYSTEMIC LUPUS ERYTHEMATOSUS TREATMENTS: A DISCRETE CHOICE EXPERIMENT". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 264.2–264. http://dx.doi.org/10.1136/annrheumdis-2022-eular.830.
Testo completoAbstract (sommario):
BackgroundFatigue, chronic pain, and skin and joint manifestations can be debilitating for people with systemic lupus erythematosus (SLE), and managing these symptoms is vital to safeguard their quality of life (QOL). In addition, oral corticosteroids (OCS) and other immunosuppressants can expose patients with SLE to severe adverse events. However, little is known about the relative importance of SLE treatment outcomes including symptom control or the extent to which treatment risks are tolerated in exchange for this.ObjectivesTo quantify the relative importance of different SLE treatment outcomes and the trade-offs patients are willing to make between these outcomes.MethodsThis online discrete choice experiment (DCE) assessed how treatment choices varied with treatment outcomes. Subjects were US adults (≥18 years) with a self-reported diagnosis of moderate-to-severe SLE (≥6 months) who experienced ≥1 flare in the past year and were taking ≥1 SLE treatment. Treatment outcomes included four benefits on: 1) fatigue levels, as in the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue, described the degree of tiredness felt by a patient in the previous 7 days, while not experiencing a flare and despite adequate sleep or rest, 2) joint and 3) non-joint pain levels as measured using the Brief Pain Inventory–Short Form (BPI-SF) scale; scores of 2, 5, and 8 correspond to mild, moderate, and severe worst daily pain on a scale of 0 (no pain) to 10 (worst imaginable pain),and 4) skin rash and itch levels, as in SLE-QOL, indicated how much patients were troubled by sore, painful, stingy, or itchy skin in the previous 7 days. Treatment outcomes also included three risks: 1) risk of infections represented by the proportion of patients who might experience an infection during treatment, 2) mild-to-moderate OCS-related side effects requiring no or only self-administered treatment and 3) severe, potentially life-threatening OCS-related side effects requiring long-term outpatient or hospital treatment. An error-component multinomial logit model was used to analyze DCE data.ResultsThe DCE survey was completed by 342 subjects with SLE (mean age 39.6 years) who were predominantly female (82%). Most participants were diagnosed with SLE ≥1 year prior (84%) and experienced ≥2 SLE flares in the previous 12 months (90%). Nearly all participants experienced joint pain (92%) and non-joint pain (84%). Treatment preferences were modelled using 3,420 subject-generated observations. Over the ranges tested, more importance was attached to symptom improvement than risk reduction (Figure 1). A reduction in joint pain (8 to 2) was most important to patients (marginal utility [MU] 0.84), followed by skin rashes and itching (‘extremely’ to ‘not at all’, MU 0.66) and non-joint pain (8 to 2, MU 0.49). Reduction of infection risk (10% to 0%) was least important (MU 0.27). Regarding the maximum acceptable risk, participants would accept a 74% increase in the risk of mild-to-moderate side effects to avoid being ‘extremely troubled’ by skin rash and itch (Table 1).Table 1.Maximum acceptable risk of mild-to-moderate oral corticosteroid side effectsAttribute levelsMaximum Acceptable Increase in Risk* [95% CI]FatigueA little bit50.06% [32.41, 67.71]Somewhat47.51% [29.92, 65.09]Very muchReferenceSkin rash and itchNot at all73.81% [51.51, 96.11]Moderately50.84% [32.37, 69.32]ExtremelyReferenceJoint pain (1-level decrease)15.63% [11.24, 20.02]Non-joint pain (1-level decrease)9.18% [6.06, 12.31]Risk of infections (1% decrease)2.99% [1.53, 4.45]Risk of severe side effects (1% decrease)1.72% [0.97, 2.47]*Calculated using an error-component multinomial logit model.Figure 1.Marginal utilities associated with changes in SLE treatment outcomesConclusionThis real-world patient preference assessment provides insights into the relative importance of SLE treatment outcomes and willingness to tolerate SLE treatment risks. These results can guide endpoint prioritization in SLE clinical studies and inform the evaluation of SLE treatments.Disclosure of InterestsHannah Collacott Consultant of: Idorsia Pharmaceuticals, Andrea Phillips-Beyer Consultant of: Idorsia Pharmaceuticals, Nicolas Krucien Consultant of: Idorsia Pharmaceuticals, Kevin Marsh Consultant of: Idorsia Pharmaceuticals, Bruno Flamion Employee of: Idorsia Pharmaceuticals
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Fouad, Ahmed M., Sally F. Elotla, Nourhan E. Elkaraly e Aly E. Mohamed. "Impact of COVID-19 Pandemic on Patients with Rheumatic and Musculoskeletal Diseases: Disruptions in Care and Self-Reported Outcomes". Journal of Patient Experience 9 (gennaio 2022): 237437352211026. http://dx.doi.org/10.1177/23743735221102678.
Testo completoAbstract (sommario):
The COVID-19 pandemic presented a challenge to the care of patients with rheumatic and musculoskeletal diseases (RMDs). The objective of this study was to evaluate the impact of the pandemic on the care of RMDs patients and their health and well-being. This cross-sectional study involved 120 RMDs patients at the rheumatology department at Suez Canal University Hospital in Ismailia, Egypt, in July 2020. Patients were interviewed for sociodemographic and disease-related history. Further assessments were performed using Kessler 6-items, fears of COVID-19, and COV19–impact on quality of life scales. Rheumatoid arthritis and systemic lupus erythematosus represented the majority of our sample of RMDs patients (72.5% and 19.2%, respectively). About 50% of patients reported experiencing limitations in the access to rheumatologic care, and a similar percentage had changed or discontinued their medications. Disease-modifying antirheumatic drugs shortage and concerns about the increased risk of COVID-19 infection due to immunosuppressive drugs were the most frequently reported reasons for nonadherence. The percentage of patients with uncontrolled disease had significantly increased from 8.3% prior to the COVID-19 pandemic to 20% during the pandemic. About 60% of patients reported a high level of psychological distress. In conclusion, the pandemic negatively influenced mental health, quality of life, adherence to medications, access to rheumatology care, and the degree of disease control of RMDs patients.
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Williams-Hall, Rebecca, Pamela Berry, Nicola Williamson, Melissa Barclay, Anna Roberts, Adam Gater, Chloe Tolley et al. "Generation of evidence supporting the content validity of SF-36, FACIT-F, and LupusQoL, and novel patient-reported symptom items for use in patients with systemic lupus erythematosus (SLE) and SLE with lupus nephritis (LN)". Lupus Science & Medicine 9, n. 1 (agosto 2022): e000712. http://dx.doi.org/10.1136/lupus-2022-000712.
Testo completoAbstract (sommario):
ObjectiveSLE and lupus nephritis (LN) have significant impacts on the health-related quality of life of patients living with the condition, which are important to capture from the patient’s perspective using patient-reported outcomes (PROs). The objectives of this study were to evaluate the content validity of PROs commonly used in SLE and LN (36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) and Lupus Quality of Life (LupusQoL), as well as novel PRO symptom severity items measuring skin rash, joint pain, joint stiffness and swelling of the legs and/or feet, in both populations.MethodsQualitative, semi-structured, cognitive interviews were conducted with 48 participants (SLE=28, LN=20). Understanding and relevance of symptom and impact PRO concepts from existing PROs were assessed, alongside novel PRO symptom severity items with different recall periods (24 hours vs 7 days) and response scales (Numerical Rating Scale (NRS) vs Verbal Rating Scale). Interviews were conducted in multiple rounds to allow for modifications to the novel PRO items. Analysis of verbatim interview transcripts was performed.ResultsSymptom and impact concepts assessed by the SF-36, FACIT-F, and LupusQoL were well understood by both participants with SLE and LN (≥90.0%), with most considered relevant by over half of the participants asked (≥51.9%). All participants asked (100%) understood the novel PRO symptom severity items, and the majority (≥90.0%) considered the symptoms relevant. Minor modifications to the novel PRO items were made between rounds to improve clarity based on participant feedback. The selected 7-day recall period and NRS in the final iteration of the PRO items were understood and relevant. No differences in interview findings between the SLE and LN samples were identified.ConclusionsFindings provide evidence of content validity for concepts assessed by the SF-36, FACIT-F, LupusQoL and the novel PRO symptom severity items, supporting use of these PROs to comprehensively assess disease impact in future SLE and LN clinical trials.
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Fredi, M., C. Orlandi, M. Salvi, C. Bazzani, C. Nalli, L. Andreoli e F. Franceschini. "POS0117 DISEASE ACTIVITY AND CLINICAL REMISSION IN SYSTEMIC LUPUS ERYTHEMATOSUS: COMPARISON BETWEEN PATIENT AND PHYSICIAN PERSPECTIVES BY MEANS OF PATIENT REPORTED OUTCOMES (PROs)". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 283.2–284. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2761.
Testo completoAbstract (sommario):
BackgroundIn daily clinical practice, it is not rare to observe a relevant discordance between patient’s global assessment (PGA) and physician’s global assessment (PhGA), because of different illness perceptions.ObjectivesTo evaluate the presence of PGA/PhGA discrepancy in patients with Systemic Lupus Erythematosus (SLE) who achieved clinical remission and to evaluate how this discrepancy affects PROs. In addition, to explore whether this discordance could be influenced by the presence of additional elements affecting patients’ quality of life, such as comorbidities, sleep disturbances and psycho-emotional factors.MethodsOur study included adult SLE patients consecutively followed in a single Lupus Clinic from March to July 2021 fulfilling at minimum the definition of clinical remission of treatment according to Zen et al. (1) (cSLEDAI=0, corticosteroids ≤5mg/die, stable dosage of DMARD). Medical records including demographic data, clinical characteristics and outcomes measures were collected. Pain assessment, PGA and PhGA were rated on a visual analogue scale (0-100 mm) on the same day of the clinical evaluation. To analyse the discrepancy between PGA and PhGA, the [PGA-PhGA] variable was calculated, considering as discordant a difference ≥ 25 mm as previously proposed (2) All the subjects completed the following questionnaires: Health Assessment Questionnaire (HAQ), SF36 Health Survey, State-Trait Anxiety Inventory (STAI-Y1/Y2), Self-rating Depression Scale (SDS Zung) and Insomnia Severity Index. Statistical analysis was performed to compare concordant and discordant groups.ResultsThe study included 106 patients, (93 women, 13 men) with a median age of 48 (41-58) and a median SLE duration 227 months (124-330). At the last evaluation median SLEDAI was 0 (0-2) and median SLICC was 1 (0-1). According to Zen definitions of remission, 51 patients (48%) and 20 (19%) also fulfilled the criteria of clinical remission off corticosteroids and complete remission respectively. Nevertheless, in 24 patients (22,7%) [PGA-PhGA]≥25. Patients in the discordant group were older (median 58 years, IQR 49-62 vs 46, IQR 39-57; p=0,0043) and less frequently achieved the definition of clinical remission off corticosteroids (n=4, 16,7% vs n=47, 57,3%,p<0.001;OR6,7; CI95%2.1-21) than concordant. No differences were found in gender, SLE duration, serology, disease activity or damage and other treatment. Data about differences in PROs between two groups are reported in Table 1: discordant patients had a worse performance in all the PROs included. At multivariate analysis SF-36 Physical Component Summary (PCS) resulted associated with [PGA-PhGA] ≥25 (p=<0,0001).Table 1.Data are expressed as median and interquartile range (IQR) and compared using Mann-Whitney test.TOTAL N=106 (%)CONCORDANT GROUP (PGA-PhGA) <25N=82 (%)DISCORDANT GROUP (PGA-PhGA) ≥25N=24 (%)P valueVAS-pain [0-100],10 (0-30)10 (0-20)50 (40-60)< 0.001SF-36 Physical Component Summary (PCS)50 (37,5-53)51 (44-54)30 (27,5-39)< 0.001SF-36 Mental Component Summary (PCS)48 (38-55)51 (40-55)40 (36-48,5)0,015STAI-Y1 [20-80]35 (30-47)33 (28,3-45,5)42 (36,5-49,5)0,013STAI-Y2 [20-80]37 (30-46)35 (29-43,3)42 (36-46)0,021Test di Zung [20-80]34,5 (29-43)33 (27-43)39 (35,5-44,5)0,008Insomnia severity index [0-28]6 (2-12)4 (1-9)9 (6,8-14,3)<0,0001HAQ0 (0-0,1)0 (0-0)0,38 (0-0,6)< 0.001ConclusionIn our study we found that, even in patients considered in remission, in more than 20% of patients there is a considerable discordance between the global disease assessment reported by patients and their physicians. Patients that had a higher PGA also presented worse score at PROs. Our data seems to confirm that potential causes for discordance could be more related to the presence of non-inflammatory processes, depression, or anxiety than clinical manifestations or damage related to SLE.References[1]Zen et al. Ann. Rheum. Dis. 2015;74:2117–2122[2]Neville C, et al. J Rheumatol 2000;27:675-9Disclosure of InterestsNone declared
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Reutemann, E., R. Brinks, J. G. Richter, R. Fischer-Betz, B. Winkler-Rohlfing, M. Aringer, M. Schneider e G. Chehab. "POS0362 FACTORS ASSOCIATED WITH CHANGES IN COPING BEHAVIOUR IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS - A LONGITUDINAL STUDY OF THE LuLa COHORT". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 434.3–434. http://dx.doi.org/10.1136/annrheumdis-2022-eular.918.
Testo completoAbstract (sommario):
BackgroundPatients with Systemic Lupus Erythematosus (SLE) experience both physical and psychosocial restrictions that negatively impact their quality of life. Coping mechanisms have turned out to be important contributors to health-related outcomes, not only in SLE but also other chronic conditions. However, there is limited understanding of factors that enhance or hamper coping in SLE.ObjectivesTo analyse parameters associated with longitudinal changes in coping behaviour in patients with SLE who take part in a long-term SLE patient cohort study.MethodsSince 2001, the German nationwide SLE patient longitudinal (Lupus Langzeit ‘LuLa’) study annually administers self-reported questionnaires to SLE patients.In addition to demographic and the annually probed extended clinical data (e.g., medication, disease activity, fatigue, depression), in both 2009 and 2014 we assessed the Pain-related Self Statements Scale (PRSS) to perceive information related to coping behaviour. This includes ‘positive coping’ as well as catastrophizing as a dysfunctional form of coping behaviour.Statistical analysis was accomplished by a linear regression model adjusting for age, pain, number of comorbidities and net income. The PRSS score difference from 2009 and 2014 was used as the dependent variable. Factors from the i) medical (involvement of the skin, pain, fatigue), ii) activity (basic, leisure, sports), iii) intrinsic (depression, kinesiophobia, perceived health control), and iv) social participation categories were entered as independent variables.Results272 patients (96.7% female) provided valid PRSS questionnaires in both 2009 and 2014. In 2009 the mean age in this cohort was 51 years (SD 11.2) with an average disease duration of 16.2 years (SD 8.3). The mean reported lupus activity (VAS 0-10) during the last three months was 3.7 (SD 2.4). During the six-year observation period, the proportion of improvement (46.2%) and deterioration (47.4%) in coping score was almost balanced, while in catastrophizing score more participants improved (50.0%) than deteriorated (37.0%).A perceived high internal control, thus the belief that health outcomes are contingent on personal behaviour, was associated with an improvement in the coping score [HLC, b=0.061 (95%-CI 0.014; 0.109), p=0.012]. Conversely, high external control convictions, e.g., the belief that doctors and other third parties determine health outcomes, were associated with a worse coping score [HLC, b=-0.090 (95%-CI -0.154; -0.026), p=0.006]. Deterioration in depression [ADS-L, b=0.015, (95%-CI 0.006; 0.025), p=0.002] and impaired social participation [IMET, b=0.043, (95%-CI 0.000; 0.085), p=0.050] were associated with a deterioration of catastrophizing, whereas better internal control [HLC, b=-0.046, (95%-CI -0.080; -0.012), p=0.009] was associated with its improvement.Mucocutaneous involvement, fatigue and the extent of physical activity were not significantly associated with either coping or catastrophizing scores in the regression analysis.ConclusionIn line with data from other chronic diseases, our findings in a longitudinal SLE cohort emphasise the role of intrinsic factors, such as mental health status and self-efficacy, improving the quality of life in SLE patients via successful coping behaviour. Affirmative action measures and programs to improve social participation may yield additional benefits.AcknowledgementsThe LuLa study is supported by unrestricted grants from GlaxoSmithKline, UCB Pharma and AstraZeneca.Disclosure of InterestsEmily Reutemann: None declared, Ralph Brinks: None declared, Jutta G. Richter Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Rebecca Fischer-Betz Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Borgi Winkler-Rohlfing: None declared, Martin Aringer: None declared, Matthias Schneider Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study., Gamal Chehab Grant/research support from: GlaxoSmithKline and UCB Pharma for performing the LuLa-study.
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Mucke, Johanna, Oliver Kuss, Ralph Brinks, Sabine Schanze e Matthias Schneider. "LUPUS-BEST—treat-to-target in systemic lupus erythematosus: study protocol for a three-armed cluster-randomised trial". Lupus Science & Medicine 8, n. 1 (luglio 2021): e000516. http://dx.doi.org/10.1136/lupus-2021-000516.
Testo completoAbstract (sommario):
IntroductionAs chronic systemic autoimmune disease, which can affect every organ, SLE is creating significant burden and increased mortality. Despite better outcomes over the past decades by optimising standard of care, new interventions are needed for further improvements. Changing strategy to ‘treat-to-target’ (T2T) may be a promising concept proven successful in other chronic diseases.Methods and analysisIn this cluster-randomised trial, SLE centres will be assigned 1:1:1 to standard of care (SoC), remission (no clinical disease activity+prednisolone ≤5 mg/day+Physician Global Assessment (PGA 0–3) <0.5±immunomodulatory treatment) or and Lupus Low Disease Activity State (LLDAS, low disease activity+prednisolone ≤7.5 mg/day+PGA ≤1+no new disease activity). Per arm, 424 patients will be included. Intervention centres receive a standardised training on T2T and shared decision-making (SDM). In intervention centres, patients not in target enter a phase of tight control with six weekly visits and treatment adjustments (at least four visits) or until the target is reached and maintained. Patients in target are reassessed every 12 weeks. In case of flare, they can enter tight control based on SDM. In the SoC arm, patients receive their usual three to six monthly controls and treatment adjustments according to the physician’s discretion. Study duration is 120 weeks using change in damage and health-related quality of life (HRQoL) as major outcomes. The primary endpoint will be damage accrual at 120 weeks as measured by the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index and will by analysed by a mixed model.ConclusionsThis is the first trial to assess if the implementation of a T2T concept in clinical care minimises damage accrual and improves HRQoL in patients with SLE. Comparison of remission and LLDAS will help to identify the target with the best benefit–risk ratio concerning attainability, adverse events and damage. The emphasis on SDM will strengthen patient autonomy and will improve both their satisfaction and medical condition.
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Williams, E. M., C. L. Dismuke, T. D. Faith, B. L. Smalls, E. Brown, J. C. Oates e L. E. Egede. "Cost-effectiveness of a peer mentoring intervention to improve disease self-management practices and self-efficacy among African American women with systemic lupus erythematosus: analysis of the Peer Approaches to Lupus Self-management (PALS) pilot study". Lupus 28, n. 8 (5 giugno 2019): 937–44. http://dx.doi.org/10.1177/0961203319851559.
Testo completoAbstract (sommario):
Objective The Peer Approaches to Lupus Self-management (PALS) program was developed as a peer mentoring tool to improve health behaviors, beliefs, and outcomes in African American women with systemic lupus erythematosus (SLE). This study aims to assess the cost of the PALS intervention and determine its effectiveness when compared to existing treatments. Methods Peer mentors and mentees were paired on shared criteria such as life stage, marital status, or whether they were mothers. This 12-week program consisted of a weekly peer mentoring session by telephone. Cost of healthcare utilization was evaluated by assessing the healthcare costs pre- and post-intervention. Validated measures of quality of life, self-management, disease activity, depression, and anxiety were collected. Total direct program costs per participant were totaled and used to determine average per unit improvement in outcome measures. The benefit-cost ratio and pre- versus post-intervention hospital charges were examined. Results A total of 20 mentees and 7 mentors were enrolled in the PALS program. All PALS pairs completed 12 sessions lasting an average of 54 minutes. Mentees reported statistically significant decreases in patient-reported disease activity, depression, and anxiety, with improved trends in patient activation or patient engagement in their disease and management. The total cost per patient was $1291.50, which was $107.62 per patient per week. There was a savings of $23,417 per individual receiving the intervention with a benefit-cost ratio of 18.13 per patient. Conclusion These findings suggest that the PALS intervention was effective in improving patient-level factors and was cost-effective. Future research will need to validate these findings in a larger sample.
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Blomjous, B., G. Gajadin, I. Bultink, A. Voskuyl, L. Falzon, J. Hoving e M. Ter Wee. "FRI0156 WORK PARTICIPATION IN PATIENTS WITH SYSTEMATIC LUPUS ERYTHEMATOSUS: A SYSTEMATIC REVIEW". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 662.1–662. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3555.
Testo completoAbstract (sommario):
Background:The treatment of systemic lupus erythematosus (SLE) has improved over the last decades, however, absenteeism and work disability numbers remain higher than those observed in the general population (1). SLE has its onset between the ages of 20 and 40 years, and has a major burden on the lives of patients, both mentally and financially. A recent online survey amongst 2070 European SLE patients revealed that 69.5% of patients had their careers affected due to SLE (2).Objectives:To determine the magnitude of absenteeism and work disability in patients with SLE and to investigate the factors that might affect work participation in these patients in order to develop interventions to reduce the impact of the burden in the future.Methods:A systematic literature search was performed to identify published articles reporting on the prevalence of work related burden, as well as the relation of having SLE on employment status, sick leave and/or presenteeism. Full-text original articles (all languages) published before April 2019 were identified by literature search performed in MEDLINE, Cochrane, Embase and CINAHL.Results:In total, 2057 non-duplicate citations were screened after database searching and snowballing. Finally, 81 articles were included; most studies (n=59) had a cross-sectional design and the remaining 22 studies had a longitudinal design. Only 15 longitudinal cohort studies reported on associations, 6 studies described a longitudinal prediction model, 2 studies reported on associations and described a prediction model, and 3 studies had a longitudinal design but only reported on prevalences over time. In total, 3500 working patients were included in the studies reporting on associations or describing a longitudinal prediction model. In the association studies, the most frequently used outcome measures were respectively being employed/probability of being employed and work loss/job cessation. Other studies used loss of days from (non)workforce activities/sick leave days, work disability, productivity loss or work entry. Most associations with work outcome were found for demographic variables and two or three disease variables, like Systemic Lupus Activity Questionnaire (SLAQ) score and depressive symptoms. This was also the case in the prediction studies. Most studies did not assess work related variables as possible predictors for work outcome.Conclusion:A large heterogeneity was found in type of study design and outcome measures, which limits comparison with other studies. More longitudinal studies are needed to truly assess the impact of SLE on work participation, and to identify factors that could be influenced during interventions, in order to encourage work participation of these patients.References:[1]Bultink IE, Turkstra F, Dijkmans BA, Voskuyl AE. High prevalence of unemployment in patients with systemic lupus erythematosus: association with organ damage and health-related quality of life. J Rheumatol. 2008;35(6):1053-7.[2]Gordon C, Isenberg D, Lerstrom K, Norton Y, Nikai E, Pushparajah DS, et al. The substantial burden of systemic lupus erythematosus on the productivity and careers of patients: a European patient-driven online survey. Rheumatology (Oxford). 2013;52(12):2292-301.Disclosure of Interests:None declared
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Aringer, M., L. Arnaud, C. Peschken, R. Furie, E. F. Morand, C. Seo, E. Rapsomaniki et al. "POS0731 ASSOCIATION OF PATIENT-REPORTED OUTCOMES WITH TYPE I INTERFERON GENE SIGNATURE FROM THE INTERNATIONAL SYSTEMIC LUPUS ERYTHEMATOSUS PROSPECTIVE OBSERVATIONAL COHORT STUDY (SPOCS)". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 648–49. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1181.
Testo completoAbstract (sommario):
BackgroundThe aim of the Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS) is to examine the disease course of patients with systemic lupus erythematosus (SLE) in relation to their type I interferon gene signature (IFNGS) status.1 IFNGS has been associated with SLE disease activity.2ObjectivesTo identify associations between IFNGS status and patient-reported outcomes (PROs) among patients receiving clinical care while enrolled in SPOCS.MethodsThis noninterventional, international, prospective, observational cohort study included adult patients (≥18 years) with moderate to severe SLE receiving standard therapy. Short Form 36 Health Survey version 2 (SF-36; 0–100), Lupus Quality of Life (LupusQoL; 0–100) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; 0–52) were assessed at baseline, 6 months, and 12 months. Higher scores indicate better outcomes. Analyses were stratified by high or low IFNGS status (4-gene test) at baseline.ResultsOf 827 patients, mean (standard deviation [SD]) age was 45.1 (14.0) years, 771 (93%) were female, 525 (63%) were IFNGS high, and 219 (26%) were IFNGS low. IFNGS-high patients were younger than IFNGS-low (mean [SD] 43.0 [13.7] vs 50.7 [12.9] years), had fewer comorbidities (83% vs 91%) and similar baseline disease activity (mean [SD]: SLE Disease Activity Index 2000, 9.8 [4.3] vs 9.2 [5.2]; Physician’s Global Assessment, both 1.5 [0.6]). At baseline, there were some differences in PROs between IFNGS-high and -low patients. At Month 12, changes in most domains did not meet the minimal clinically important difference (MCID). Slight improvement was observed only in selected domains in the IFNGS-high group. This group was younger and had fewer comorbidities at baseline. (Table 1, Figure 1).Table 1.PRO Scores at Baseline and Month 12 by IFNGS StatusBaselineMonth 12Change From BaselineMCID (≥)PROTotal (n=810)IFNGS HighIFNGS Low (n=219)Total (n=431)IFNGS HighIFNGS Low (n=147)TotalIFNGS HighIFNGS Low(n=525)(n=279)SF-36Physical Component Summary37.4 (10.5)38.3 (10.5)+35.2 (10.6)139.8 (10.8)41.7 (10.4)+35.7 (10.8)2.3 (7.6)3.0 (8.1)*0.6 (6.4)2.5Mental Component Summary43.2 (11.6)43.6 (11.7)42.7 (11.6)44.9 (11.2)45.9 (10.6)43.4 (11.5)0.9 (9.2)1.4 (9.6)-0.3 (8.4)2.5LupusQoLPhysical health56.4 (27.4)58.1 (27.0)+52.1 (27.7)60.5 (26.9)65.0 (25.3)+52.5 (27.7)2.6 (18.1)5.0 (19.2)*-1.4 (16.4)3.4Pain54.3 (30.3)55.7 (29.8)50.2 (30.8)61.4 (28.5)66.0 (26.5)+52.6 (29.1)5.4 (23.8)8.1 (25.2)0.7 (21.3)8.5Planning61.4 (32.2)63.7 (31.8)+57.0 (32.2)66.3 (29.6)70.8 (27.8)+58.5 (30.8)2.9 (24.4)4.2 (24.7)-1.0 (22.9)6.5Intimate relationships58.0 (34.8)61.2 (34.1)+50.9 (34.8)59.8 (33.9)65.6 (32.3)+50.6 (34.7)-0.6 (24.5)-0.7 (25.9)-0.8 (22.3)9.2Burden to others50.7 (32.6)50.7 (32.6)50.4 (33.5)56.4 (30.7)59.7 (29.5)51.8 (31.7)3.1 (25.4)5.6 (26.0)*0.1 (23.9)5.3Emotional health66.3 (25.6)66.1 (26.0)67.8 (24.8)71.1 (24.7)72.9 (23.8)69.2 (24.7)1.8 (19.4)3.1 (20.3)-0.5 (18.1)3.4Body image62.6 (29.4)61.0 (30.1)66.4 (28.3)68.2 (27.6)70.3 (27.4)65.1 (27.0)2.0 (23.9)*4.1 (24.3)*-0.4 (22.1)1.1Fatigue48.6 (27.8)49.9 (27.6)45.5 (28.2)53.7 (26.9)57.4 (26.2)+46.9 (25.7)2.1 (19.3)3.5 (20.0)-0.9 (18.7)3.9FACIT-F25.8 (13.4)26.9 (13.4)+23.4 (12.9)28.7 (13.2)31.1 (12.7)+24.6 (12.9)2.3 (9.6)3.2 (10.2)0.6 (8.5)4.0Data are mean (SD). Asterisks (*) indicate changes from baseline ≥ MCID. +Comparison between high and low IFNGS status by Mann-Whitney U test (nominal p-value<0.01).Data for n are patients per subgroup and do not reflect responses per PRO assessment.ConclusionIn this cohort study, patients with moderate to severe SLE had poor health status, health-related quality of life, and fatigue. A clinically meaningful change was not met in most PROs, suggesting patients continue to have a high need for improved treatment options.References[1]Hammond ER. BMJ Open 2020;10:e036563.[2]Dall’era MC. Ann Rheum Dis 2005;64:1692–7.AcknowledgementsWriting assistance by Shelley Harris, PhD (Fishawack). This study was sponsored by AstraZeneca.Disclosure of InterestsMartin Aringer Speakers bureau: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, HEXAL, Lilly, MSD, Mylan, Novartis, Roche, Sanofi, UCB, Consultant of: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Galapagos, GSK, Pfizer, Roche, Sanofi, Laurent Arnaud Speakers bureau: AstraZeneca, Consultant of: AstraZeneca, Grant/research support from: AstraZeneca, Christine Peschken Consultant of: AstraZeneca, GSK, Grant/research support from: AstraZeneca, Richard Furie Speakers bureau: AstraZeneca, Genentech, Consultant of: AstraZeneca, Grant/research support from: AstraZeneca, Eric F. Morand Speakers bureau: GSK, Novartis, Paid instructor for: AstraZeneca, Biogen, Eli Lilly, Consultant of: AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, EMD Serono, Genentech, GSK, Janssen, Servier, Grant/research support from: Abbvie, AstraZeneca, Bristol Myers Squibb, GSK, Janssen, Caroline Seo Shareholder of: AstraZeneca, Employee of: AstraZeneca, Eleni Rapsomaniki Employee of: AstraZeneca, Jonatan Hedberg Shareholder of: AstraZeneca, Employee of: AstraZeneca, Jacob Knagenhjelm Shareholder of: AstraZeneca, Employee of: AstraZeneca, Tina Grünfeld Eén Shareholder of: AstraZeneca, Employee of: AstraZeneca, Barnabas Desta Shareholder of: AstraZeneca, Employee of: AstraZeneca, Raj Tummala Shareholder of: AstraZeneca, Employee of: AstraZeneca, Alessandro Sorrentino Shareholder of: Galapagov, Abbott Laboratories, Gilead Sciences, Moderna, Employee of: Janssen, Sanofi, AstraZeneca, Heide Stirnadel-Farrant Shareholder of: AstraZeneca, GSK, Employee of: AstraZeneca
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Gomez, Alvaro, Sofia Soukka, Petter Johansson, Emil Åkerström, Sharzad Emamikia, Yvonne Enman, Katerina Chatzidionysiou e Ioannis Parodis. "Use of Antimalarial Agents Is Associated with Favourable Physical Functioning in Patients with Systemic Lupus Erythematosus". Journal of Clinical Medicine 9, n. 6 (10 giugno 2020): 1813. http://dx.doi.org/10.3390/jcm9061813.
Testo completoAbstract (sommario):
Impaired health-related quality of life (HRQoL) is a major problem in patients with systemic lupus erythematosus (SLE). Antimalarial agents (AMA) are the cornerstone of SLE therapy, but data on their impact on HRQoL are scarce. We investigated this impact using baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (n = 1684). HRQoL was self-reported using the Medical Outcomes Study short-form 36 (SF-36), functional assessment of chronic illness therapy (FACIT)-Fatigue and 3-level EuroQoL 5-Dimension (EQ-5D) questionnaires. Patients on AMA (n = 1098/1684) performed better with regard to SF-36 physical component summary, physical functioning, role physical, bodily pain, FACIT-Fatigue, EQ-5D utility index and EQ-5D visual analogue scale scores. The difference in SF-36 physical functioning (mean ± standard deviation (SD): 61.1 ± 24.9 versus 55.0 ± 26.5; p < 0.001) exceeded the minimal clinically important difference (≥5.0). This association remained significant after adjustment for potential confounding factors in linear regression models (standardised coefficient, β = 0.07; p = 0.002). Greater proportions of AMA users than non-users reported no problems in the mobility, self-care, usual activities and anxiety/depression EQ-5D dimensions. AMA use was particularly associated with favourable HRQoL in physical aspects among patients with active mucocutaneous and musculoskeletal disease, and mental aspects among patients with active renal SLE. These results provide support in motivating adherence to AMA therapy. Exploration of causality in the relationship between AMA use and favourable HRQoL in SLE has merit.
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Jesus, D., A. Matos, C. Henriques, A. Doria e L. Inês. "POS0119 SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES ARE ASSOCIATED WITH IMPROVED HEALTH-RELATED QUALITY OF LIFE AND FATIGUE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS." Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 284.2–285. http://dx.doi.org/10.1136/annrheumdis-2022-eular.3634.
Testo completoAbstract (sommario):
BackgroundAccurate and practical outcome measures for clinical trials in systemic lupus erythematosus (SLE) are lacking. The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item instrument, with high accuracy and sensitivity to changes in SLE disease activity. The SLE-DAS definitions of remission and low disease activity (LDA) were newly validated against disease activity physician-applied measures in the clinical setting [1, 2]. Criterion validity of SLE-DAS for Patient Reported Outcomes, namely health-related quality of life (HR-QoL) and fatigue needs to be assessed.ObjectivesTo evaluate if the attainment of SLE-DAS remission and LDA states is associated with improvements in HR-QoL and fatigue.MethodsPost-hoc analysis of the merged study population in the BLISS-52 and -76 trials (NCT00424476; NCT00410384) of intravenous belimumab versus placebo for moderate to severe SLE disease activity. We analysed the Functional Assessment of Chronic Illness Therapy (FACIT) and 36-Item Short Form Survey (SF-36) trial data. Fulfillment of SLE-DAS remission (defined as absence of all SLE-DAS clinical items and prednisone ≤5mg/day) and LDA (defined as SLE-DAS≤2.48 and prednisone ≤7.5mg/day) definitions were retrospectively assessed from the individual participants’ data. Mean changes from study baseline to week 52 in FACIT and SF-36 physical component summary (PCS) and mental component summary (MCS) and domain scores were compared between patients attaining at week 52 the SLE-DAS remission vs non-remission and the SLE-DAS LDA vs non-LDA using multivariate regression analysis adjusted for baseline scores.ResultsA total of 1684 SLE patients were included. Few patients were in SLE-DAS remission (0.5%) and LDA (0.8%) at study entry. At week 52, 12.5% patients attained SLE-DAS remission and 17.5% attained SLE-DAS LDA. Mean improvements in SF-36 PCS and MCS scores were greater in patients that attained SLE-DAS remission vs non-remission (5.4 vs 3.4, and 4.6 vs 2.7, respectively; multivariate p<0.005 for both) and SLE-DAS LDA vs non-LDA (5.0 vs 3.4 and 4.6 vs 2.6, respectively; multivariate p<0.005 for both), at week 52 (Figure 1). Similarly, improvements in all individual domain scores were greater in SLE-DAS remission vs non-remission patients (all multivariate p<0.005) and SLE-DAS LDA vs non-LDA patients (all multivariate p<0.005) (Figure 1). Importantly, improvements in the summary scores and in all the individual domain scores largely exceeded the minimum clinically important differences (MCIDs) of 2.5 and 5 points, respectively, in those patients attaining SLE-DAS remission or LDA.Figure 1.Mean changes in SF-36 domains and summary scores from baseline to week 52. #p<0.005; *p<0.001; MICD, Minimum Clinically Important Difference; MCS, Mental Component Summary; PCS, Physical Component Summary; SF-36, Medical Outcomes Survey Short Form; SLE-DAS, Systemic Lupus Erythematosus Disease Activity Score.Additionally, mean improvements in FACIT scores were higher in SLE-DAS remission than non-remission (6.3 vs 3.6, multivariate p<0.001) and in SLE-DAS LDA than non-LDA (5.9 vs 3.6, multivariate p<0.001), and exceeded the MCID of 4 points.ConclusionAttainment of SLE-DAS remission and LDA is associated with meaningful improvement in HR-QoL and fatigue.References[1]Jesus D, et al. Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity. Ann Rheum Dis 2021;80:1568-74.[2]Assunção H, et al. Definition of Low Disease Activity State based on the SLE-DAS: Derivation and validation in a multicentre real-life cohort. Rheumatology (Oxford) 2021;3;keab895.AcknowledgementsThe authors would like to thank GlaxoSmithKline (Uxbridge, UK) for granting access to the data from the BLISS-52 and 76 trials through the Clinical Study Data Request consortium.Disclosure of InterestsNone declared
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Ugarte-Gil, M. F., R. V. Gamboa Cárdenas, C. Reategui Sokolova, V. Pimentel-Quiroz, M. Medina Chinchon, C. Elera-Fitzcarrald, Z. Rodriguez Bellido, C. Pastor Asurza, R. Perich Campos e G. S. Alarcon. "POS0730 A BETTER SELF-EFFICACY IS PREDICTIVE OF BETTER HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS. DATA FROM A LATIN AMERICAN MESTIZO COHORT". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 647.2–647. http://dx.doi.org/10.1136/annrheumdis-2022-eular.727.
Testo completoAbstract (sommario):
BackgroundSystemic lupus erythematosus (SLE) patients have a worse health-related quality of life (HRQoL) than the general population. This seems to be related to patients characteristics like age, poverty, behavioral issues rather than to disease activity or damage. Self-efficacy is defined as individual’s confidence on performing a task and could impact on patient-reported outcomes.ObjectivesTo determine the possible predictive value of self-efficacy on HRQoL in SLE patients.MethodsSLE patients from a single-center prevalent cohort were included. Self-efficacy was ascertained with six instruments of the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for Managing Chronic Conditions. Instruments included were general self-efficacy, and self-efficacy for managing emotions, managing symptoms, managing daily activities, managing social interactions and managing medications and treatments. For PROMIS instruments, a score of 50 is the average for a clinical population (people with a chronic condition), a higher score indicates that the respondent has greater self-efficacy. HRQoL was ascertained with the physical and mental component summary (PCS and MCS) measures of the Short-Form 36 (SF-36). Generalized estimating equations were performed, using as outcome the PCS or MCS in the subsequent visit, and the self-efficacy instrument in the previous visit; multivariable models were adjusted for possible confounders (age at diagnosis, gender, socioeconomic status, SLEDAI-2K, SLICC/ACR damage index, disease duration at baseline, prednisone daily dose, antimalarial and immunosuppressive drugs use and PCS or MCS in the previous visit). All the confounders were measured in the same visit than the self-efficacy instrument.ResultsTwo-hundred and nine patients for a total of 564 visits were included; 194 (92.8%) patients were women, mean age at diagnosis was 36.4 (14.0) years and disease duration at baseline was 6.5 (6.0) years. At baseline, PCS was 55.0 (22.3) and MCS was 53.9 (20.4). At baseline, mean general self-efficacy was 47.2 (10.4), self-efficacy for managing emotions was 44.6 (8.0), for managing symptoms was 47.7 (8.2), for managing daily activities was 45.5 (7.5) for managing social interactions was 42.9 (7.9) and for managing medications and treatment was 43.9 (7.0). In the multivariable models a better PCS was predicted by a better general self-efficacy, and self-efficacy for managing symptoms, managing social interactions and managing medications and treatments and a better MCS was predicted by a better self-efficacy for managing symptoms, managing daily activities, managing social interactions and managing medications and treatments. These data are depicted in Table 1.Table 1.The predictive value of self-efficacy on HRQoL in SLE patientsPCSMCSUnivariable modelMultivariable modelUnivariable modelMultivariable modelB (SE)p valueB (SE)p valueB (SE)p valueB (SE)p valueGeneral0.98 (0.11)<0.0010.18 (0.08)0.0370.92 (0.11)<0.0010.20 (0.10)0.051Managing emotions0.99 (0.16)<0.0010.12 (0.11)0.2571.05 (0.15)<0.0010.17 (0.11)0.161Managing symptoms1.26 (0.14)<0.0010.25 (0.11)0.0211.19 (0.13)<0.0010.32 (0.12)0.006Managing daily activities1.59 (0.13)<0.0010.22 (0.13)0.0911.44 (0.13)<0.0010.39 (0.13)0.002Managing social interactions0.77 (0.15)<0.0010.27 (0.09)0.0020.86 (0.14)<0.0010.37 (0.10)<0.001Managing medications and treatment#0.71 (0.17)<0.0010.20 (0.10)0.0460.65 (0.16)<0.0010.24 (0.10)0.016PCS: Physical component summary. MCS: Mental component summary. SE: Standard error. * Adjusted for age at diagnosis, gender, socioeconomic status, SLEDAI-2K, SLICC/ACR damage index, disease duration at baseline, prednisone daily dose, antimalarial and immunosuppressive drugs use and PCS or MCS in the previous visit. #Only patients taking at least one medication were included in these analyses.ConclusionA better self-efficacy is predictive of a subsequent better HRQoL, even after adjustment for possible confounders. These results should encourage clinicians to develop strategies to improve self-efficacy in SLE patients.Disclosure of InterestsManuel F. Ugarte-Gil Grant/research support from: Janssen, Pfizer, Rocío Violeta Gamboa Cárdenas Grant/research support from: Pfizer, Cristina Reategui Sokolova Grant/research support from: Janssen, Victor Pimentel-Quiroz Grant/research support from: Janssen, Mariela Medina Chinchon: None declared, Claudia Elera-Fitzcarrald: None declared, Zoila Rodriguez Bellido: None declared, Cesar Pastor Asurza: None declared, Risto Perich Campos: None declared, Graciela S Alarcon: None declared
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Touma, Z., B. Hoskin, C. Atkinson, D. Bell, J. Pike, J. H. Lofland, P. Berry, C. Karyekar e K. Costenbader. "AB1170 THE IMPACT OF HIGH DISEASE ACTIVITY AS MEASURED BY SLEDAI AND DRUG BURDEN-ON HEALTHCARE UTILIZATION, QUALITY OF LIFE AND WORK PRODUCTIVITY IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 1875.2–1876. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5872.
Testo completoAbstract (sommario):
Background:Although there is abundant literature on healthcare utilization in SLE patients, the impact of disease activity in SLE patients is not well understood.Objectives:To quantify the impact of disease activity, as measured by SLEDAI score and drug burden, in SLE patients on health care resource utilization (HCRU), health related quality of life (HRQoL) and work productivity (WP).Methods:Data were collected from a cross-sectional survey of 754 rheumatologists in US and EU5 from the Adelphi Real World 2010/2013/2015 Lupus Disease Specific Programmes (DSP). Physicians were asked to complete patient record forms (PRFs) for the next 5 prospectively consulting SLE patients; the same patients were asked to complete patient self-completion (PSC) forms describing how SLE affected them. PRFs collected data pertaining to the patient’s diagnosis, disease history, current clinical outcomes, treatment and management history. PSCs focused on similar data collection and included patient reported outcome measures (PROs). Propensity score matching was used to assess differences in HCRU and PRO scores between SLE patients who had a low disease activity and those who had a high disease activity. Low disease activity was defined as a SLEDAI score of ≤4, a steroid dose of <7.5mg/day, and not on immunosuppressant or biologic. High disease activity was a SLEDAI score of >4, or on an immunosuppressant, biologic, or steroid dose of >7.5mg/day. Patients were matched on age, sex, and ethnicity.Results:Data was extracted from 1278 PRFs, and 591 PSCs. Using the estimated propensity score each low disease activity patient (n=44) was matched with a high disease activity patient (n=1187). Using 1:1 matching, with replacement and allowing for ties, matching resulted in 414 high disease activity patients being used as matches for 44 low disease activity patients. Demographic data are reported in Table 1. Patients with a low disease activity were significantly less likely to be currently flaring, lower number of flares in last 12 months, less likely to have been hospitalized in the last 12 months, had fewer consultations in the last 12 months, reported better HrQoL (EQ5D), more favourable levels of fatigue (FACIT), and lower work impairment (WPAI). (Table 2).Table 1.Demographic dataVariableLow disease activityHigh disease activityMean age (years)38.140.0% Female90.788.2% White/Caucasian76.767.7Mean years diagnosed5.55.0Table 1.Propensity score matching resultsOutcome variableLow activity meanHigh activity meanCoefficient95% CIp-valueFlared in the last 12 months11.6337.97-0.26[-0.38 – -0.14]<0.001Number of flares in last 12 months0.210.70-0.49[-0.72 - -0.26]<0.001Hospitalised in last 12 months4.6514.98-0.10[-0.17 – -0.04]0.001Number of consults in last 12 months2.843.52-0.68[-1.19 – -0.17]0.009EQ-5D-3L0.780.880.10[0.03 – 0.17]0.004FACIT Fatigue34.6839.865.19[0.80 – 9.57]0.02WPAI overall percentage work impairment14.4245.35-30.93[-45.32 – -16.54]<0.001Conclusion:Systemic lupus erythematosus patients with lower levels of disease activity are less burdensome to the healthcare system and experience a significantly better HRQoL and lower levels of productivity impairment. There is a need to establish a universal definition of low disease activity as a treatment goal to benefit patient quality of life and reduce HCRU.Study funded by Johnson and Johnson.Disclosure of Interests:Zahi Touma Consultant of: Consultant for Janssen, Ben Hoskin Consultant of: Consultant for Janssen, Christian Atkinson Consultant of: Consultant for Janssen, David Bell Consultant of: Janssen, James Pike Consultant of: Janssen, Jennifer H. Lofland Employee of: Janssen, Pamela Berry Employee of: Janssen, Chetan Karyekar Shareholder of: Johnson & Johnson, Consultant of: Janssen, Employee of: Janssen Global Services, LLC. Previously, Novartis, Bristol-Myers Squibb, and Abbott Labs., Karen Costenbader Grant/research support from: Merck, Consultant of: Astra-Zeneca
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Mannix, S., A. Beyer, V. Strand, L. Hanrahan, C. Abél, B. Flamion e A. Hareendran. "AB1249 ASSESSMENT OF FATIGUE IN ADULTS WITH MODERATE-TO-SEVERE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): A QUALITATIVE STUDY TO EXPLORE WHAT PATIENTS FEEL SHOULD BE MEASURED IN CLINICAL TRIALS". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 1916. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3849.
Testo completoAbstract (sommario):
Background:Fatigue is one of the most common symptoms reported by patients with systemic lupus erythematosus (SLE)—it is responsible for considerable loss of work time and greatly impaired quality of life. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) has been used to assess fatigue in SLE clinical trials1; however, assessment of the content validity of the FACIT-F in adults with SLE suggested that closer evaluation may be warranted.2Objectives:This qualitative study aimed to understand SLE patients’ experience of fatigue and assess the content validity of the FACIT-F.Methods:The evaluation was informed by literature and guided by a project steering committee (PSC; patient advocate, clinical expert, outcomes measure expert). The institutional review board-approved study involved focus groups (Round 1) and cognitive interviews (Round 2) with adults with moderate-to-severely active SLE. All participants provided written informed consent. Round 1 included three focus groups to understand the disease and fatigue-related concepts that were most important to patients; participants also provided high-level feedback on the FACIT-F. Round 2 included 13 one-on-one cognitive interviews on the relevance of content, clarity, and comprehensiveness of the FACIT-F. Interviews were audio-recorded and transcribed and a content analysis was completed. The PSC reviewed results and contributed to decision-making. Specific focus was on determining patient understanding of the FACIT-F, comprehensiveness, and any gaps in concept coverage to evaluate fatigue in the context of a clinical trial.Results:Twenty-eight patients with moderate-to-severely active SLE participated; they were mostly female (n=27), had a mean age of 45.5 ± 12.1 years (range: 18–75), and 23 (82%) had moderate and five (18%) severely active SLE. All participants were receiving SLE treatment, and most (n=23, 82%) reported fatigue among their top three most important SLE-related symptoms. Fatigue was described as having a profound impact on daily life, including ability to perform chores and work-related activities, maintain personal hygiene, exercise, and participate in hobbies. Study participants reported the FACIT-F covered concepts most relevant to their fatigue experience. Participants were able to understand the FACIT-F instructions, items, and response options and felt the recall period of seven days was appropriate.Conclusion:Fatigue was one of the most important symptoms, having a significant impact on adults with moderate-to-severely active SLE, limiting their ability to perform necessary or desired activities. The FACIT-F was found to be an appropriate measure for the assessment of fatigue in this sample.3Evidence of the content validity of the FACIT-F in adults with SLE was confirmed for use to support endpoints in the Cenerimod Assessing S1P1Receptor Modulation in SLE (CARE) clinical trial.References:[1]Izadi Z, Gandrup J, Katz PP, Yazdany J. Patient-reported outcome measures for use in clinical trials of SLE: a review. Lupus Sci Med. 2018;5(1):e000279.[2]Kosinski M, Gajria K, Fernandes A, Cella D. Qualitative validation of the FACIT-Fatigue scale in systemic lupus erythematosus. Lupus. 2013;22(5):422-430.[3]Mannix S, Beyer A, Strand V, Hanrahan L, Abel C, Flamion B, Hareendran A. Assessment of Fatigue in Adults with Moderate to Severe Systemic Lupus Erythematosus (SLE): A Qualitative Study to Explore What Patients Feel Should Be Measured in Clinical Trials [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).Acknowledgments:We thank Dr. David Cella, developer of the FACIT-F, for his time discussing the measure, interim findings, and PSC feedback; the site staff for patient recruitment; Andrea Schulz and Rodolfo Matos, who conducted interviews.Disclosure of Interests:Sally Mannix Employee of: Evidera, Andrea Beyer Employee of: Idorsia Pharmaceuticals, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Leslie Hanrahan: None declared, Cristina Abél Employee of: Evidera, Bruno Flamion Shareholder of: Idorsia Pharmaceuticals, Employee of: Idorsia Pharmaceuticals, Asha Hareendran Employee of: Evidera
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Gomez, A., I. Parodis e C. Sjowall. "AB0549 OBESITY AND TOBACCO SMOKING ARE INDEPENDENTLY ASSOCIATED WITH POOR PATIENT-REPORTED OUTCOMES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS FROM A SWEDISH TERTIARY REFERRAL CENTRE". Annals of the Rheumatic Diseases 81, Suppl 1 (23 maggio 2022): 1402.1–1402. http://dx.doi.org/10.1136/annrheumdis-2022-eular.4335.
Testo completoAbstract (sommario):
BackgroundPatients with systemic lupus erythematosus (SLE) experience impaired health-related quality of life (HRQoL), pain, fatigue and functional disability. The effect of pharmacotherapy on these aspects has been inconclusive in literature. In light of this, investigation of the impact of lifestyle facets is needed to support complementary non-pharmacological interventions such as weight control strategies and tobacco smoking cessation.ObjectivesTo evaluate associations of obesity and tobacco smoking with SLE patients’ HRQoL, pain, fatigue and functional disability.MethodsPatients from the Linköping University Hospital with an SLE diagnosis according to the 1982 American College of Rheumatology (ACR) and/or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria (n=325) were included in the present cross-sectional analysis of data captured at visits between January 2008 and September 2021. Among consecutive visits, the first visit with complete demographic, clinical and patient-reported data was selected for the present analysis.Body mass index (BMI) categories were based on the World Health Organization classification: underweight (BMI <18.5 kg/m2), normal weight (18.5≤ BMI <25 kg/m2), pre-obesity (25≤ BMI <30 kg/m2) and obesity (BMI ≥30 kg/m2). Smoking status was self-reported and categorised into never, prior and current smoking.HRQoL was self-reported using the 3-level EuroQoL 5-Dimension (EQ-5D-3L) index scores. Visual analogue scales (VAS; 0–100) were used to self-report fatigue, pain and well-being within the preceding 7 days. Functional disability was evaluated using the Swedish version of the Health Assessment Questionnaires Disability Index (HAQ-DI). Disease activity was evaluated using the clinical (c)SLEDAI-2K (serology excluded).Comparisons of continuous data between different BMI and smoking categories were performed using the Mann-Whitney U test and Kruskal-Wallis test. Multivariable linear regression analysis was employed to assess independence and priority of contributors to HRQoL and functional impairment.ResultsCompared with normal weight, obese individuals reported lower EQ-5D-3L index score [0.73 (0.36–0.80) versus 0.78 (0.68–0.85); P=0.014], as well as higher VAS fatigue [50.0 (27.0–72.5) versus 32.0 (6.5–59.5); P=0.008], VAS pain [40.0 (11.0–67.0) versus 20.5 (5.3–46.5); P=0.011] and HAQ scores [0.63 (0.13–1.13) versus 0.13 (0.0–0.63); P<0.001]. Similarly, ongoing smokers reported higher VAS fatigue [56.0 (28.0–78.0) versus 32.0 (8.0–58.0); P=0.001], VAS pain [45.0 (18.0–62.0) versus 18.0 (5.0–39.8); P=0.001] and HAQ scores [0.63 (0.13–1.13) versus 0.13 (0.0–0.63); P=0.001] compared with individuals who were never exposed to regular tobacco smoking. There were no differences across groups regarding cSLEDAI-2K scores.In multivariable linear regression models, obesity and current tobacco smoking were independently associated with lower EQ-5D-3L index scores (β=-0.12; P=0.021 and β=-0.11; P=0.029, respectively), and higher VAS fatigue (β=12.8; P=0.007 and β=17.5; P<0.001), VAS pain (β=12.1; P=0.004 and β=15.5; P<0.001), VAS well-being (β=9.6; P=0.028 and β=9.8; P=0.035) and HAQ scores (β=0.30; P=0.001 and β=0.27; P=0.007), but not with cSLEDAI-2K (β=-0.73; P=0.189 and β=0.34; P=0.572).ConclusionIn a Swedish SLE population, obesity and ongoing tobacco smoking were independently associated with worse outcomes - compared with normal weight and individuals who never smoked, respectively - regarding HRQoL, fatigue, pain and functional disability but were not associated with clinical disease activity.Disclosure of InterestsNone declared
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Khattab, Nada M., Maggie Abbassi, Hala A Raafat e Samar Farid. "A pharmacoeconomic study comparing the use of mycophenolate mofetil or cyclophosphamide as induction therapy in lupus nephritis patients in Egypt". Lupus 31, n. 4 (7 marzo 2022): 505–16. http://dx.doi.org/10.1177/09612033221083270.
Testo completoAbstract (sommario):
Introduction/objectives Lupus nephritis (LN) is a major and serious complication of systemic lupus erythematosus (SLE) and is associated with morbidity and mortality. The difference in drug cost between mycophenolate mofetil (MMF) and cyclophosphamide (CYC) inducing regimens becomes a relevant and realistic issue, especially in developing countries. Thus, this study aims to estimate and compare the costs and outcomes of CYC and MMF for better allocation of resources to reduce the burden on the Egyptian healthcare system. Methods A prospective, parallel observational study was conducted at Kasr Al-Aini Hospital between 2018 and 2020. One hundred and twenty-two LN patients were followed up monthly during the study period. Remission and maintenance of renal remission were assessed at 6 and 12 months from the start of therapy. Total direct medical costs associated with both regimens were examined. We applied the cost-minimization analysis method from governmental perspective. Besides, a prospective evaluation of reported changes in health-related quality of life using SF-36 was included in our study. Results There was no statistically significant difference in treatment response at 6 and 12 months (RR 0.6 [0.26;1.43] and 0.8 [0.27;2.33]), respectively, as well as the incidence of infection episodes between MMF and CYC group (71.4% versus 70.45%, p > 0.05). The average direct medical expenditures per patient in the MMF group were approximately one and half times more than the CYC group (2339.69 $ versus 1329.03 $, p <0.001). Conclusion The CYC arm was associated with lower costs than the MMF arm, with equally effective outcomes indicating that CYC is an attractive treatment option.
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Azizoddin, D. R., R. Olmstead, C. Cost, M. Jolly, J. Ayeroff, G. Racaza, L. A. Sumner, S. Ormseth, M. Weisman e P. M. Nicassio. "A multi-group confirmatory factor analyses of the LupusPRO between southern California and Filipino samples of patients with systemic lupus erythematosus". Lupus 26, n. 9 (6 gennaio 2017): 967–74. http://dx.doi.org/10.1177/0961203316686706.
Testo completoAbstract (sommario):
Introduction Systemic lupus erythematosus (SLE) leads to a range of biopsychosocial health outcomes through an unpredictable and complex disease path. The LupusPRO is a comprehensive, self-report measure developed specifically for populations with SLE, which assesses both health-related quality of life and non-health related quality of life. Given its increasingly widespread use, additional research is needed to evaluate the psychometric integrity of the LupusPRO across diverse populations. The objectives of this study were to evaluate the performance of the LupusPRO in two divergent patient samples and the model fit between both samples. Methods Two diverse samples with SLE included 136 patients from an ethnically-diverse, urban region in southern California and 100 from an ethnically-homogenous, rural region in Manila, Philippines. All patients met the ACR classification criteria for SLE. Confirmatory factor analysis (CFAs) were conducted in each sample separately and combined to provide evidence of the factorial integrity of the 12 subscales in the LupusPRO. Results Demographic analyses indicated significant differences in age, disease activity and duration, education, income, insurance, and medication use between groups. Results of the separate CFAs indicated moderate fit to the data for the hypothesized 12-factor model for both the Manila and southern California groups, respectively [χ2 (794) = 1283.32, p < 0.001, Comparative Fit Index (CFI) = 0.793; χ2 (794) =1398.44, p < 0.001, CFI = 0.858]. When the factor structures of the LupusPRO in the southern California and Manila groups were constrained to be equal between the two groups, findings revealed that the factor structures of measured variables fit the two groups reasonably well [χ2 (1697) = 2950.413, df = 1697, p < 0.000; CFI = 0.811]. After removing seven constraints and eight correlations suggested by the Lagrange multiplier test, the model fit improved significantly [χ2 (15) = 147.165, p < 0.000]. Conclusions This research provides significant support for the subscale structure of the LupusPRO in two disparate cultural samples of SLE patients. Despite significant sociodemographic and clinical differences between the two samples, for the most part, the LupusPRO performed similarly in both samples.
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Berry, P., K. Burrows, R. Hall, A. Gater, H. Bradley, A. Ward, C. Tolley, P. Delong e E. C. Hsia. "AB1332-HPR ASSESSING THE PATIENT EXPERIENCE OF LUPUS NEPHRITIS: DEVELOPMENT OF A CONCEPTUAL MODEL AND REVIEW OF EXISTING PATIENT-REPORTED OUTCOME (PRO) MEASURES". Annals of the Rheumatic Diseases 79, Suppl 1 (giugno 2020): 1954.1–1955. http://dx.doi.org/10.1136/annrheumdis-2020-eular.5634.
Testo completoAbstract (sommario):
Background:Lupus nephritis (LN) is an autoimmune disease characterized by inflammation of the kidneys as a result of systemic lupus erythematosus (SLE). Approximately 50% of SLE patients will develop LN, which is considered to be one of the most severe manifestations of SLE and the leading cause of morbidity and mortality in SLE. While there is ample existing evidence on disease experience and PROs used in extra-renal SLE, little research has been done in LN. Qualitative interviews with patients can help identify concepts that are both important and relevant to the patient. In order to effectively evaluate treatment benefit, it is critical that PRO measures used to assess such concepts and define clinical trial endpoints are fit for purpose and have strong evidence of content validity in the specific context of use.Objectives:The objective of this study was to understand the patient experience of LN and to identify and characterize the signs and symptoms of LN and their impact on health-related quality of life (HRQoL) through the development of a disease-specific conceptual model. This model was then used to evaluate the content validity of existing PRO measures available for use in LN.Methods:A structured literature search was conducted in Medline, Embase and PsycINFO to identify qualitative research articles documenting the patient experience of LN. PRO measures developed or commonly used to assess patient experiences of LN were also identified. Semi-structured concept elicitation interviews were conducted with 15 adult patients in the US with a clinician-confirmed diagnosis of LN (defined in accordance with established clinical guidelines). Supplementary qualitative data were also collected from a review of publicly available online blogs/forums. Findings were used to inform the development of a conceptual model detailing the impact of LN signs, symptoms and HRQoL and evaluate the validity of existing measures used within LN.Results:Searches revealed a paucity of qualitative research conducted with LN patients, supporting the need for prospective research in LN. Consistent with existing literature in SLE, the core signs and symptoms identified from the qualitative literature review, interviews and blog/forum review included joint pain, fatigue, joint stiffness, swelling (particularly in the extremities) and skin rashes. LN patients also reported urinary frequency, urgency, foamy urine and blood in their urine. Disease impact on physical functioning, activities of daily living, emotions, social life, work/finances and sleep were reported. PRO measures commonly used to evaluate patient experiences in LN included the SF-36, LupusQOL, LupusPRO, SLE Symptom Checklist, KDQoL and KSQ. Conceptual mapping of instruments against the newly developed conceptual model (Figure 1) highlighted that no single measure provides a comprehensive assessment of all symptoms/impact important to LN patients. Furthermore, items are largely focused on impact of symptoms with few items on symptom severity.Figure 1.Conceptual model of lupus nephritis symptoms and associated impactsConclusion:The presentation of signs and symptoms in LN patients appears similar to those reported in extra-renal SLE populations, with the addition of swelling and urinary symptoms. Qualitative research with LN patients guided the development of a comprehensive LN conceptual model outlining the disease experience from the patients’ perspective. These insights can be useful to inform PRO measurement strategies for clinical trials in LN.Acknowledgments:With thanks to Dr. Betty Diamond and Dr. David Wofsy for their collaboration and helpful insightsDisclosure of Interests:Pamela Berry Employee of: Janssen, Kate Burrows Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract, Rebecca Hall Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract., Adam Gater Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract, Helena Bradley Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract, Amy Ward Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract, Chloe Tolley Consultant of: Adelphi Values a health outcomes research company commissioned by Janssen to conduct the research reported in this abstract, Patricia Delong Employee of: Janssen, Elizabeth C Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC
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George, James N. "TTP: long-term outcomes following recovery". Hematology 2018, n. 1 (30 novembre 2018): 548–52. http://dx.doi.org/10.1182/asheducation-2018.1.548.
Testo completoAbstract (sommario):
Abstract Although risk for relapse may be the greatest concern following recovery from acquired, autoimmune thrombotic thrombocytopenic purpura (TTP), there are multiple other major health issues that must be recognized and appropriately addressed. Depression may be the most common disorder following recovery from TTP and may be the most important issue for the patient’s quality of life. Severe or moderate depression has occurred in 44% of Oklahoma Registry patients. Recognition of depression by routine screening evaluations is essential; treatment of depression is effective. Minor cognitive impairment is also common. The recognition that cognitive impairment is related to the preceding TTP can provide substantial emotional support for both the patient and her family. Because TTP commonly occurs in young black women, the frequency of systemic lupus erythematosus, as well as other autoimmune disorders, is increased. Because there is a recognized association of TTP with pregnancy, there is always concern for subsequent pregnancies. In the Oklahoma Registry experience, relapse has occurred in only 2 of 22 pregnancies (2 of 13 women). The frequency of new-onset hypertension is increased. The most striking evidence for the impact of morbidities following recovery from TTP is decreased survival. Among the 77 patients who survived their initial episode of TTP (1995-2017), 16 (21%) have subsequently died, all before their expected age of death (median difference, 22 years; range 4-55 years). The conclusion from these observations is clear. Following recovery from TTP, multiple health problems occur and survival is shortened. Therefore, careful continuing follow-up is essential.
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Azizoddin, D. R., N. Gandhi, S. Weinberg, M. Sengupta, P. M. Nicassio e M. Jolly. "Fatigue in systemic lupus: the role of disease activity and its correlates". Lupus 28, n. 2 (22 dicembre 2018): 163–73. http://dx.doi.org/10.1177/0961203318817826.
Testo completoAbstract (sommario):
Objectives Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that leads to a variety of negative health outcomes resulting from inflammation in various organ systems. Although treatment continues to advance, fatigue remains one of the most salient, poorly understood and addressed patient complaints. Understanding the mechanisms of fatigue can help guide the development of interventions to improve health outcomes. The aim of this research was to evaluate the contribution of six variables (disease activity, insomnia, depression, stress, pain and physical health) to fatigue in SLE without concomitant fibromyalgia (FM). Methods A total of 116 ethnically diverse, primarily female participants (91%) with SLE, receiving care at university medical centers, completed assessments of disease activity and quality of life outcomes (FACIT-FT, Insomnia Severity Index, Perceived Stress Scale (PSS-4), Pain Inventory, Depression-PHQ-9, and LupusPRO-physical function). All patients met the American College of Rheumatology classification criteria for SLE and did not have a known diagnosis of FM. Multivariate linear and stepwise regression analyses were conducted with fatigue (FACIT-FT) as the dependent variable, and the above six variables as independent variables. Results Mean (SD) age was 39.80 (13.87) years; 50% were African American, 21% Caucasian, 13% Hispanic, 9% Asian and 8% other. Mean (SD) FACIT-FT was 20.09 (12.76). Collectively, these six variables explained 57% of the variance in fatigue. In the multivariate model, depression, stress and pain were significantly and independently associated with fatigue, but not disease activity, sleep or physical health. Stress had the largest effect on fatigue (β 0.77, 95% CI 0.17–1.38, p = 0.01), followed by depression (β 0.66, 95% CI 0.21–1.10, p = 0.005). On stepwise regression analysis, only stress, depression and pain were retained in the model, and collectively explained 56% of the variance in fatigue. All three remained independent correlates of fatigue, with the largest contribution being stress (β 0.84, 95% CI 0.27–1.42, p = 0.005), followed by depression (β 0.79, 95% CI 0.44–1.14, p < 0.001) with fatigue. Conclusion Stress, depression and pain are the largest independent contributors to fatigue among patients with SLE, without concurrent FM. Disease activity, sleep and physical health were not associated with fatigue. The evaluation of stress, depression and pain needs to be incorporated during assessments and clinical trials of individuals with SLE, especially within fatigue. This stress-depression-fatigue model requires further validation in longitudinal studies and clinical trials. Significance and innovation: • Disease activity, sleep, pain, stress, depression, and physical health have been reported individually to be associated with fatigue in lupus. This analysis evaluated the role of each and all of these six variables collectively in fatigue among patients with SLE without a known diagnosis of FM. • Disease activity, sleep and physical health were not significantly related to fatigue, but depression, stress and pain were. • The results emphasize the need to evaluate and treat fatigue in individuals with SLE utilizing a biopsychosocial approach, particularly in the realm of clinical trials. Behavioral medicine interventions are shown to be most effective for the treatment of depression, stress and pain.