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Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.

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Schiff, Michael Takeuchi, Tsutomu Fleischmann, Roy Gaich, Carol L DeLozier, Amy M Durez, Patrick [UCL] Zerbini, Cristiano A F

BACKGROUND: This study evaluates patient-reported outcomes (PROs) in a double-blind, phase III study of baricitinib as monotherapy or combined with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with no or minimal prior conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and naïve to biological DMARDs. METHODS: Patients were randomized 4:3:4 to MTX administered once weekly (N = 210), baricitinib monotherapy (4 mg once daily (QD), N = 159), or combination of baricitinib (4 mg QD) and MTX (baricitinib + MTX, N = 215). PROs included the Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration of morning joint stiffness (MJS), worst joint pain, worst tiredness, Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA), Short Form 36 version 2, Acute (SF-36); and EuroQol 5-Dimensions (EQ-5D) Health State Profile. Comparisons were assessed with analysis of covariance (ANCOVA) and logistic regression models. RESULTS: Compared to MTX, patients in both baricitinib groups reported greater improvement (p ≤ 0.01) in HAQ-DI, PtGA, pain, fatigue, worst join pain, SF-36 physical component score, and EQ-5D at weeks 24 and 52. For the SF-36 mental component score, patients in both baricitinib groups reported statistically significant improvements (p ≤ 0.01) at week 52 compared to MTX-treated patients. Statistically significant improvements (p ≤ 0.05) were observed with the WPAI-RA for the baricitinib groups vs. MTX at week 24 and for the WPAI-RA daily activity and work productivity measures for baricitinib + MTX at week 52. CONCLUSIONS: In this study, baricitinib alone or in combination with MTX, when used as initial therapy, resulted in significant improvement compared to MTX in the majority of the pre-specified PRO measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01711359 . Registered on 18 October 2012.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2017
Language Anglais
Journal information "Arthritis Research & Therapy" - Vol. 19, no.1, p. 208 [1-10] (2017)
Peer reviewed yes
Publisher BioMed Central Ltd. ((United Kingdom) London)
issn 1478-6354
e-issn 1478-6362
Publication status Publié
Affiliations UCL - SSS/IREC/RUMA - Pôle de Pathologies rhumatismales
UCL - (SLuc) Service de rhumatologie
Keywords Baricitinib ; HAQ-DI ; Health-related quality of life ; JAK inhibitor ; PRO ; RA ; Rheumatoid ; health status indicators ; tsDMARD
Links
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Bibliographic reference Schiff, Michael ; Takeuchi, Tsutomu ; Fleischmann, Roy ; Gaich, Carol L ; DeLozier, Amy M ; et. al. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment.. In: Arthritis Research & Therapy, Vol. 19, no.1, p. 208 [1-10] (2017)
Permanent URL http://hdl.handle.net/2078.1/201852