PDF(Pubmed)
Abstract：
Background: Tildrakizumab, the IL-23 inhibitor, is used to treat plaque psoriasis and psoriatic arthritis. Many studies have reported adverse drug reactions (ADRs) associated with Tildrakizumab. Objective: The aim of this study was to describe ADRs associated with Tildrakizumab monotherapy by mining data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The signals of Tildrakizumab-associated ADRs were quantified using disproportionality analyses such as the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) algorithms. Results: A total of 10,530,937 reports of ADRs were collected from the FAERS database, of which 1,177 reports were identified with tildrakizumab as the \"primary suspect (PS)\". Tildrakizumab-induced ADRs occurred against 27 system organ classes (SOCs). A total of 32 significant disproportionality Preferred Terms (PTs) conformed to the algorithms. Unexpected significant ADRs such as coronavirus infection, herpes simplex, diverticulitis, atrial fibrillation and aortic valve incompetence were also possible. The median time to onset of Tildrakizumab-associated ADRs was 194 days (interquartile range [IQR] 84-329 days), with the majority occurring, within the first 1 and 3 months after initiation of Tildrakizumab. Conclusion: This study identified a potential signal for new ADRs with Tildrakizumab, which might provide important support for clinical monitoring and risk prediction.
摘要：
背景：Tildrakizumab，IL-23抑制剂，用于治疗斑块状银屑病和银屑病关节炎。许多研究报道了与Tildrakizumab相关的药物不良反应（ADR）。目的：本研究的目的是通过挖掘美国食品和药物管理局不良事件报告系统（FAERS）的数据来描述与Tildrakizumab单药治疗相关的ADR。方法：使用不相称性分析对Tildrakizumab相关ADR的信号进行量化，例如报告比值比（ROR），比例报告比率(PRR)，贝叶斯置信度传播神经网络(BCPNN)，和多项目伽玛泊松收缩器(MGPS)算法。结果：从FAERS数据库中收集了10,530,937份ADR报告，其中1,177例报告被确定为“主要嫌疑人（PS）”。Tildrakizumab诱导的ADR针对27种系统器官类别（SOC）发生。总共32个显著不成比例的优选术语(PT)符合算法。意外的重大ADR，如冠状病毒感染，单纯疱疹,憩室炎,房颤和主动脉瓣关闭不全也有可能.Tildrakizumab相关ADR的中位发病时间为194天（四分位距[IQR]84-329天），随着大多数发生，在开始使用Tildrakizumab后的前1个月和3个月内。结论：这项研究确定了Tildrakizumab的新ADR的潜在信号，这可能为临床监测和风险预测提供重要支持。
