Effect of Sarilumab on Unacceptable Pain and Inflammation Control in Japanese Patients with Moderately-to-severely Active Rheumatoid Arthritis: Post Hoc Analysis of a Phase III Study (KAKEHASI)

Objective The aim of this study is to investigate the effects of sarilumab on unacceptable pain [UP; visual analogue scale (VAS) >40 mm] and inflammation in patients with moderately-to-severely active rheumatoid arthritis. Methods In this post hoc analysis of the KAKEHASI study, 243 patients received methotrexate with sarilumab 150 or 200 mg or placebo every other week, over 52 weeks. The proportion of patients with UP and correlations of changes in pain VAS from baseline with uncontrolled inflammation (C-reactive protein & GE;1 mg/dl) and disease activity indices were assessed. Results Almost 80% of patients (192/243) had UP at baseline, including & SIM;60% of patients with uncontrolled inflammation. Among patients receiving sarilumab, inflammation decreased rapidly, with 90% of patients achieving controlled inflammation by Week 2, while 63.1% continued to have UP. The proportion of patients with UP further decreased by Week 16 (28.5%, sarilumab vs. 64.0%, placebo). By Week 52, only & SIM;10% of patients had UP. Changes in pain VAS correlated with most disease activity indices and patient-reported outcomes. However, marked correlations between changes in pain VAS and C-reactive protein were observed only at Week 16. Conclusion Sarilumab treatment reduced UP and inflammation in Japanese patients with rheumatoid arthritis.