Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study

Background: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). Methods: In this double-blind Phase 3 study, patients were randomized 3:3:2 to placebo (N=488), baricitinib 4 mg once daily (N=487), or adalimumab 40-mg biweekly (N=330) with background MTX. PROs included the SF-36, EuroQol 5-D (EQ-5D) index scores and visual analog scale (VAS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity (PtGA), patient’s assessment of pain, and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and measures collected in electronic patient daily diaries: duration and severity of morning joint stiffness (MJS), Worst Tiredness and Worst Joint Pain. The primary study endpoint was at Week 12. Treatment comparisons were assessed with logistic regression for categorical measures or analysis of covariance for continuous variables. Results: Compared to placebo and adalimumab, baricitinib showed statistically significant improvements (p≤0.05) in HAQ-DI, PtGA, pain, FACIT-F, SF-36 physical component score, EQ-5D index scores, and WPAI-RA daily activity at Week 12. Improvements were maintained for measures assessed to Week 52. Statistically significant improvement in patient diary measures (MJS duration and severity), Worst Tiredness and Worst Joint Pain were observed for baricitinib versus placebo and adalimumab at Week 12 (p≤0.05). Conclusions: Baricitinib provided significantly greater improvement in most PROs compared to placebo and adalimumab, including physical function, MJS, pain, fatigue and quality of life. Improvement was maintained to the end of the study (Week 52)