Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years' follow-up.

ABSTRACT:

Objective

Sarilumab is a human monoclonal antibody that blocks IL-6 from binding to membrane-bound and soluble IL-6 receptor-α. We assessed the long-term safety of sarilumab in patients from eight clinical trials and their open-label extensions.

Methods

Data were pooled from patients with rheumatoid arthritis who received at least one dose of sarilumab in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; combination group) or as monotherapy (monotherapy group). Treatment-emergent adverse events (AEs) and AEs and laboratory values of special interest were assessed.

Results

2887 patients received sarilumab in combination with csDMARDs and 471 patients received sarilumab monotherapy, with mean exposure of 2.8 years and 1.7 years, ma

SUBMITTER: Fleischmann R 

PROVIDER: S-EPMC7571482 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature