Post-marketing safety signals of anifrolumab in systemic lupus erythematosus: a pharmacovigilance study based on FAERS.

ABSTRACT:

Objective

Anifrolumab, a monoclonal antibody targeting the type I interferon-α receptor, has been approved for the treatment of moderate-to-severe systemic lupus erythematosus (SLE). This study aimed to assess its safety profile in real-world settings.

Methods

This study analyzed all adverse events reports involving anifrolumab as the primary suspected drug from the quarter of 2021 to the third quarter of 2024 in the FDA Adverse Event Reporting System database. Disproportionality analyses were conducted using reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker, and Bayesian confidence propagation neural network. The temporal risk of AEs was modeled using the Weibull distribution.

Results

The most frequently reported AEs included upper

SUBMITTER: Cheng Y 

PROVIDER: S-EPMC12278508 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature