Disproportionality analysis of upadacitinib-related adverse events in inflammatory bowel disease using the FDA adverse event reporting system.

ABSTRACT:

Background

Upadacitinib, a Janus kinase inhibitor, has been increasingly used over the past few years to treat moderate to severe ulcerative colitis and Crohn's disease in patients who are insufficiently responsive or intolerant to tumor necrosis factor (TNF) antibodies, demonstrating notable clinical efficacy. The long-term safety of upadacitinib in extensive populations remains unexplored. This study evaluates upadacitinib-related adverse events (AEs) utilizing data from the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

We employed disproportionality analyses, including the proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) alg

SUBMITTER: Wang S 

PROVIDER: S-EPMC11851071 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature