Safety of Sarilumab in the treatment of rheumatoid arthritis: a real-world study based on the FAERS database.

ABSTRACT:

Background

Rheumatoid Arthritis (RA) is a chronic autoimmune disease causing joint pain, swelling, and systemic symptoms like fatigue, with higher incidence in females and increased risk with age. It often co-exists with depression, imposing a significant global health burden with high annual cases and substantial economic losses. Sarilumab, a fully humanized IgG1 monoclonal antibody targeting the IL-6 receptor α, has shown efficacy in clinical trials but requires real-world safety monitoring.

Methods

This study analyzed Sarilumab-related adverse drug event (ADE) reports from the FAERS database (Q2 2017-Q1 2025). Data were cleaned and analyzed using SAS 9.4, with signal detection via Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagat

SUBMITTER: Wang D 

PROVIDER: S-EPMC12450943 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature