Key clinical point: Long-term sarilumab with or without background conventional synthetic disease-modifying antirheumatic drugs (csDMARD) was safe and provided sustained or improved clinical efficacy along with no new safety signals in patients with active rheumatoid arthritis (RA).
Major finding: Among patients receiving sarilumab monotherapy and sarilumab+csDMARD therapy, 88.3% and 92.1% of patients experienced ≥1 treatment-emergent adverse event (TEAE) and TEAE-related death rates were 1.8% and 2.1%, respectively; no new safety signals were identified. The proportion of patients achieving Clinical Disease Activity Index remission was maintained for all treatment groups.
Study details: This study evaluated 2021 and 320 patients with active RA from two open-label extension (OLE) trials (EXTEND and MONARCH, respectively) who had inadequate response, intolerance, or failure with treatment with methotrexate or tumor necrosis factor inhibitors and received sarilumab with or without csDMARD.
Disclosures: This study was supported by Sanofi. The OLE studies were sponsored by Sanofi and Regeneron. Four authors declared being employees of or holding shares or stock options in Sanofi. Several authors reported ties with Sanofi, Regeneron, and other sources.
Source: Burmester GR et al. Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis. Rheumatology (Oxford). 2023 (Feb 2). Doi: 10.1093/rheumatology/kead062