Differential risk of adverse drug reactions with baricitinib across age groups: integrating real-world pharmacovigilance and genetic causal inference.

ABSTRACT:

Background

Baricitinib is widely used for immune-mediated diseases, yet real-world safety in underrepresented age groups and the temporal dynamics of adverse drug reactions (ADRs) remain insufficiently characterized.

Objective

To identify age-stratified ADR signals of baricitinib and to examine potential causal roles of Janus kinase (JAK) 1/2 inhibition in key ADRs.

Design

A retrospective pharmacovigilance study integrating disproportionality analysis, Mendelian randomization (MR), and time-to-onset (TTO) assessment.

Methods

Baricitinib-associated ADRs reported to the FDA Adverse Event Reporting System (FAERS; Q3-2018 to Q1-2024) were analyzed using Reporting Odds Ratio and Bayesian Confidence Propagation Neural Network, stratified by age (18-65 vs ≥66 years).

SUBMITTER: Zeng H 

PROVIDER: S-EPMC12717373 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature