Disproportionality Analysis of Adverse Events Associated with IL-1 Inhibitors in the FDA Adverse Event Reporting System (FAERS).

ABSTRACT: Background: Interleukin-1 (IL-1) inhibitors are approved for the treatment of various inflammatory diseases associated with immune system abnormalities. However, large-scale real-world studies to assess their security are still limited. Therefore, a pharmacovigilance study was conducted based on the data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods: Adverse events (AEs) linked to IL-1 inhibitors were analyzed using the FAERS database from Q1 2004 to Q3 2024. Risk signals were identified through disproportionality analysis algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Results: Am

SUBMITTER: Lei J 

PROVIDER: S-EPMC12736109 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature