Safety issues of tofacitinib in rheumatoid arthritis patients: real-world pharmacovigilance.

Background: Tofacitinib is the first oral tsDMARD approved for the treatment of rheumatoid arthritis, often used as monotherapy or in combination with conventional synthetic DMARDs. However, its safety profile has yet to be systematically evaluated. Our study is the largest pharmacovigilance analysis of real-world data on the safety of tofacitinib.

Methods: Using the FAERS database (from Q1 2012 to Q1 2024), we extracted reports where tofacitinib was the primary suspect, conducting subgroup analyses stratified by gender and age. Positive signals were assessed through disproportionality analysis (criteria: ROR, PRR, BCPNN, and EBGM), identifying common ADRs across five subgroups. Further, we extracted reports with complete information on confounding factors (age, gender, weight, report time) for multivariate logistic regression to evaluate the independent effects of the intersecting ADRs.

Results: Our study reveals that, beyond known adverse reactions (such as upper respiratory tract infections and nasopharyngitis), tofacitinib is associated with numerous unreported adverse reactions, including systemic infections, tumor progression, and thrombotic risks. Many of these adverse reactions exhibit significant variability across different AD populations.

Conclusions: Enhanced monitoring is recommended for RA patients, especially those with comorbid malignancies, cardiovascular events, or infection risks, during tofacitinib therapy.