ArticleTherapeutic advances in drug safety2025
Differential risk of adverse drug reactions with baricitinib across age groups: integrating real-world pharmacovigilance and genetic causal inference.
Article in Therapeutic advances in drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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). TTO was modeled to characterize temporal patterns. Two-sample MR using eQTL-based instruments of JAK1/2 expression evaluated causal links with thrombosis and atrial fibrillation (AF). Results: Among 5354 reports, infections were most frequent (28.3%). Thrombotic events (deep vein thrombosis, pulmonary embolism) were more prominent in the elderly (≥66 years), whereas hepatic enzyme elevation and malignancies were more frequent in adults aged 18-65 years. MR suggested that higher JAK2 expression was protective against thrombosis (OR = 0.998, Conclusion: This study highlights distinct age-dependent vulnerabilities to baricitinib-associated ADRs, with genetic evidence suggesting target-specific mechanisms underlying cardiovascular risk. These findings underscore the importance of age-tailored monitoring strategies and proactive pharmacovigilance in clinical practice.
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