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

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. 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. 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. 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.

替达珠单抗（tildrakizumab）是一款获批用于中重度银屑病治疗的生物制剂。尽管其安全性已在临床试验中得到验证，但真实世界中的安全性特征仍有待进一步探究。本研究分析了2018年第一季度至2024年第一季度期间，美国食品药品监督管理局不良反应报告系统（FDA Adverse Event Reporting System, FAERS）数据库中的不良反应事件（adverse events, AEs）数据。研究采用了四种不均衡分析方法：报告比值比（Reporting Odds Ratio, ROR）、比例报告比（Proportional Reporting Ratio, PRR）、贝叶斯置信传播神经网络（Bayesian Confidence Propagation Neural Network, BCPNN）以及多项目伽马泊松收缩器（Multi-item Gamma Poisson Shrinker, MGPS），并开展了亚组分析、敏感性分析与威布尔分布（Weibull distribution）建模。最终纳入1263份报告，涉及2344例不良反应事件。研究证实了数种已知的不良反应事件，并识别出尿路感染、带状疱疹、心房颤动以及基底细胞癌等未被报道的不良反应事件。敏感性分析进一步验证了整体研究结果的可靠性。本研究既确认了部分已知不良反应事件，又发现了数种未被报道的不良反应事件，凸显了早期监测的重要性。上述结果可为替达珠单抗的安全用药提供初步参考依据。但本研究依托的FAERS数据库存在一定局限性，包括报告偏倚、临床信息不全以及无法明确因果关联，因此该研究结果仍需通过前瞻性研究进一步验证。