Tofacitinib safety in inflammatory bowel disease: a disproportionality analysis of the FDA adverse event reporting system.

Over recent years, the Janus kinase inhibitor tofacitinib has been increasingly employed in managing inflammatory bowel disease (IBD) especially for moderate-to-severe ulcerative colitis, demonstrating substantial clinical benefits. However, its long-term safety profile across diverse patient populations remains incompletely characterized. This study systematically evaluates tofacitinib-related adverse events (AEs) through comprehensive analysis of data from the FDA Adverse Event Reporting System (FAERS). We applied disproportionality analyses, incorporating the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) algorithms to detect and quantify the signals of tofacitinib-related AEs. From the 18,693,763 reports collected in the FAERS database, 399,488 cases were identified as tofacitinib-related AEs, including 7923 instances specifically linked to IBD patient management. A total of 186 significant disproportionate preferred terms (PTs) meeting all four algorithmic criteria were retained. The most frequently documented conditions included sleep disorder due to general medical condition, tender joint count, and swollen joint count. Beyond the adverse effects documented in the official product labeling, this investigation has documented several less frequently reported yet clinically significant complications, including death neonatal, retinitis, and growth disorders. Temporal distribution analysis showed the highest incidence rates occurring after one year of continuous therapy (n = 231, 28.17%) and during the initial treatment month (n = 206, 25.12%). These findings corroborate existing clinical observations while indicating potential AE signals associated with tofacitinib, underscoring the imperative for prospective clinical investigations to validate these results and clarify their clinical implications. Furthermore, this analysis delivers substantiating evidence for the ongoing safety evaluation of tofacitinib in clinical practice.