Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system

BACKGROUND: Tildrakizumab is a biologic agent approved for the treatment of moderate to severe psoriasis. Although its safety has been established in clinical trials, its real-world safety profile remains to be further investigated. RESEARCH DESIGN AND METHODS: This study analyzed adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database between the first quarter of 2018 and the first quarter of 2024. Four disproportionality analysis methods were applied: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Subgroup analyses, sensitivity analyses, and Weibull distribution modeling were conducted. RESULTS: A total of 1,263 reports involving 2,344 AEs were included. Several known AEs were confirmed, and unexpected AEs such as urinary tract infections, herpes zoster, atrial fibrillation, and basal cell carcinoma were identified. Sensitivity analysis further confirmed the reliability of the overall findings. CONCLUSIONS: This study confirmed some known AEs and identified several unexpected AEs, highlighting the importance of early-stage monitoring. These findings may provide preliminary insights into the safe use of tildrakizumab. However, the FAERS database has limitations, including reporting bias, incomplete clinical information, and the inability to establish causality. These findings warrant further validation through prospective studies.