Safety of infliximab and adalimumab in pediatric inflammatory bowel diseases: a disproportionality analysis from the FAERS database.

ABSTRACT:

Background

The incidence of pediatric inflammatory bowel disease (IBD) significantly increased recently. Infliximab (IFX) and adalimumab (ADA), both TNF-α inhibitors, are the only FDA-approved treatments for pediatric IBD. Due to the unique physiological and developmental characteristics of children, postmarketing pharmacovigilance requires ongoing attention. We aimed to evaluate the safety of IFX and ADA in pediatric IBD using FAERS database data from Q1 2004 to Q1 2024.

Methods

Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms were used to identify drug-related adverse events (AEs).

Results

In total, we retrieved 10,905 IFX-related reports and 5,446 ADA-related reports in pediatric IBD. Common AEs associated with IFX were infusion reaction

SUBMITTER: Deng Y 

PROVIDER: S-EPMC12330027 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature