Rapid and concurrent improvements in patient-reported outcomes of rheumatoid arthritis with baricitinib in ra-beam

Background: The efficacy and safety of baricitinib (BARI), an oral selective Janus kinase (JAK)1/JAK2 inhibitor, were evaluated in the randomized, controlled trial, RA-BEAM (NCT01710358), in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX).1,2,3 Objectives: To compare the time to onset and magnitude of improvement across different patient-reported outcomes (PROs) of BARI, adalimumab (ADA) and placebo (PBO) during the first 12 weeks of treatment in RA-BEAM. Methods: 1,305 patients on stable background MTX were randomized 3:3:2 to PBO, BARI 4 mg, or ADA 40 mg. In this intent-to-treat analysis, least-squares mean changes and percentage changes from baseline were assessed up to Week 12 for pain (0-100 mm visual analog scale [VAS]), SF-36 physical component summary (PCS, 0-100), morning joint stiffness (MJS) severity (0-10), Health Assessment Questionnaire-Disability Index (HAQ-DI, 0-3), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F, 0-52), and Patient Global Assessment of disease activity (PtGA, 0-100 mm VAS) scores. PROs were compared between treatments with ANCOVA; the model included change from baseline as the response variable, baseline of interest, regional baseline, joint erosion status, and treatment as explanatory variables. Last-observation-carried-forward was applied to impute missing data. Speed of onset and magnitude of PRO improvement are presented in spydergrams. Results: Statistically significant improvements (P<0.05) with BARI and ADA vs. PBO were reported as early as Week 1 for pain, MJS severity, HAQ-DI, and PtGA and at Week 4 for FACIT-F and SF-36 PCS scores. Statistically significantly larger improvements (P<0.05) with BARI vs. ADA were observed as early as Week 2 for pain, PtGA, Week 3 for MJS severity, and Week 4 for HAQ-DI and SF-36 PCS scores. These improvements were maintained to Week 12. Conclusion: Among MTX-IR pts, BARI and ADA treatment resulted in improvements across all PROs by Week 4, and as early as Week 1, for all but FACIT-F and SF-36 PCS scores. Statistically significant larger improvements for BARI compared with ADA were reported for all PROs, except FACIT-F, by Week 12.