蒂尔德拉基祖马布的安全性:基于FDA不良事件报告系统 (FAERS) 数据库的不成比例性分析,从2018-2023年开始
Jinger Lin1, Xiangqi Chen2, Min Luo1
1Department of Dermatology, The Union Hospital, Fujian Medical University, Fuzhou, Fujian, China.
Frontiers in pharmacology
|July 25, 2024
概括
这项研究分析了美国食品和药物管理局的数据,以确定与Tildrakizumab相关的不良药物反应 (ADR). 发现了新的潜在ADR信号,有助于对这种IL-23抑制剂的临床监测.
科学领域:
- 药物监督 药物监督 药物监督
- 免疫学 免疫学 免疫学
- 皮肤病学 皮肤病学
背景情况:
- 蒂尔德拉基祖马布是一种用于斑块性牛皮和牛皮性关节炎的干扰素-23 (IL-23) 抑制剂.
- 现有的研究表明,与提尔德拉基祖马布治疗相关的各种不良药物反应 (ADR).
研究的目的:
- 为了识别和描述与Tildrakizumab单一治疗相关的ADRs.
- 使用美国食品和药物管理局不良事件报告系统 (FAERS) 数据库进行信号检测.
主要方法:
- 采用不成比例分析,包括报告赔率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项马波森收缩器 (MGPS).
- 在超过1000万份ADR报告中分析了1,177份报告,其中Tildrakizumab是主要的可疑药物.
主要成果:
- 在27个系统器官类 (SOC) 中确定了32个显著不成比例的首选术语 (PT).
- 检测到潜在的新的ADR信号,包括感染 (冠状病毒,简单疹),分泌体炎,心房动和大动脉不称职.
- 中位时间到ADR发作为194天,大多数发生在Tildrakizumab开始的1-3个月内.
结论:
- 这项药监测研究发现了对Tildrakizumab的潜在新的ADR信号.
- 这些发现支持对接受提尔德拉基祖马布的患者进行加强的临床监测和风险预测策略.
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