Efficacy and safety of sarilumab in patients with rheumatoid arthritis stratified by age (<65 and ≥65 years): A post hoc analysis of Japanese Phase 3 clinical trials

Objectives This study aimed to assess the efficacy and safety of sarilumab in older patients with active rheumatoid arthritis (RA). Methods This is a post hoc analysis of KAKEHASI (NCT02293902) and HARUKA (NCT02373202) trials with stratification by age (<65 and ≥65 years). Patients with moderately to severely active RA were treated with sarilumab in combination with methotrexate or with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or as monotherapy. The primary end points in KAKEHASI and HARUKA trials were the American College of Rheumatology 20% improvement criteria (ACR20) responses at Week 24 and safety, respectively. Secondary end points were other RA disease activity measures, including Clinical Disease Activity Index (CDAI). Results Approximately 20% of patients were aged ≥65 years in treatment arms across both trials, except the sarilumab + csDMARD arm (40%, 12/30). ACR20 response rates were similar between age groups across sarilumab treatment arms, and similar results were obtained for the CDAI scores. Safety profiles were similar between age groups except for a higher incidence of serious adverse events in patients aged ≥65 years in the sarilumab + methotrexate arm. Conclusions In Japanese patients with RA enrolled in Phase 3 studies for sarilumab, no clear difference in efficacy or safety was observed between patients aged <65 and ≥65 years.