دورية أكاديمية

Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib

التفاصيل البيبلوغرافية
العنوان: Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib
المؤلفون: Laura C. Coates, Andrew G. Bushmakin, Oliver FitzGerald, Dafna D. Gladman, Lara Fallon, Joseph C. Cappelleri, Ming-Ann Hsu, Philip S. Helliwell
المصدر: Arthritis Research & Therapy, Vol 23, Iss 1, Pp 1-12 (2021)
بيانات النشر: BMC, 2021.
سنة النشر: 2021
المجموعة: LCC:Diseases of the musculoskeletal system
مصطلحات موضوعية: Psoriatic arthritis, Patient-reported outcomes, Minimal disease activity, Diseases of the musculoskeletal system, RC925-935
الوصف: Abstract Background In psoriatic arthritis (PsA), further understanding of the relationships between clinical measures and patient-reported outcomes (PROs) is needed. This post hoc analysis evaluated associations between minimal disease activity (MDA) as a continuous outcome (termed ScoreMDA) or Psoriatic Arthritis Disease Activity Score (PASDAS) with selected PROs not included in the composite measures. Methods Data from two phase 3 studies of tofacitinib in PsA (OPAL Broaden [NCT01877668; N = 422]; OPAL Beyond [NCT01882439; N = 394]) were included. MDA (binary outcome) was defined as meeting ≥5/7 criteria. For ScoreMDA, each criterion was assigned a value (1 = true; 0 = false; score range, 0–7; scores ≥5 indicated MDA). For PASDAS (score range, 0–10), higher scores indicated worse disease activity. PROs analyzed included Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Patient’s Assessment of Arthritis Pain visual analog scale (Pain VAS), and EuroQoL-Five Dimensions-Three Level Health Questionnaire visual analog scale (EQ-5D-3L VAS) and utility index. Relationships were evaluated using repeated measures regression models. Results Similar, approximately linear relationships were confirmed between PASDAS or ScoreMDA and PROs in both studies. In OPAL Broaden and OPAL Beyond, a one-point difference in PASDAS was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (− 6.7 mm, − 6.9 mm), Pain VAS (9.9 mm, 10.7 mm), and FACIT-F (− 2.8, − 3.3). A one-point difference in ScoreMDA was associated with clinically relevant differences in PROs, including EQ-5D-3L VAS (5.0 mm, 5.5 mm) and FACIT-F (1.9, 2.7) in OPAL Broaden and OPAL Beyond, respectively. Conclusions Linear associations between PASDAS or ScoreMDA and PROs provide interpretable and quantifiable metrics between composite clinical measures and PROs, highlighting the importance of these measures in understanding the relevance of treat-to-target goals in PsA. Trial registration ClinicalTrials.gov, NCT01877668 . Registered on June 12, 2013. ClinicalTrials.gov, NCT01882439 . Registered on June 18, 2013
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1478-6362
Relation: https://doaj.org/toc/1478-6362
DOI: 10.1186/s13075-021-02474-2
URL الوصول: https://doaj.org/article/cd476b3170c24c1ab4878ba4f7f11a0e
رقم الأكسشن: edsdoj.476b3170c24c1ab4878ba4f7f11a0e
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:14786362
DOI:10.1186/s13075-021-02474-2