在FAERS数据库中对ixekizumab相关不良事件的不成比例分析:现实世界药监测研究
Jia Tang1, Guanglin Liu2, Bing Lv3
1Department of Dermatology, Suining Central Hospital, Suining, Sichuan Province, China.
Medicine
|September 17, 2025
概括
这项研究分析了26867份关于ixekizumab的报告,ixekizumab是治疗牛皮和牛皮性关节炎的生物药物. 它确定了常见的不良事件,如注射部位反应和COVID-19,并标记了新的安全信号,包括感染和皮肤疾病.
科学领域:
- 免疫学 免疫学 免疫学
- 药物监督 药物监督 药物监督
- 皮肤病学 皮肤病学
背景情况:
- 伊克西祖马布是一种向介素-17A的单克隆抗体,在2016年获得了FDA的批准,用于斑块性牛皮和牛皮性关节炎.
- 营销后监测对于了解新批准的治疗药物的真实安全概况至关重要.
研究的目的:
- 使用现实数据评估ixekizumab的营销后安全性.
- 为了确定与ixekizumab治疗相关的潜在不良事件 (AE).
主要方法:
- 对食品和药物管理局不良事件报告系统 (FAERS) 数据库的分析.
- 应用四种不成比例分析方法:报告赔率比率,比例报告比率,贝叶斯信任传播神经网络和多项马波森收缩器.
- 基于所有算法预定义的标准识别安全信号.
主要成果:
- 总共有26,867份报告将ixekizumab列为主要的可疑药物.
- 在167个首选术语中确定了23,595个安全信号,常见事件包括注射部位反应,牛皮,COVID-19,鼻炎,疹和鼻炎.
- 新发现的副作用包括耳部感染,牙感染,死性带炎,平状,皮性. 从2023年开始,报告的下降趋势被观察到.
结论:
- 虽然ixekizumab的营销后安全性概况在很大程度上与临床试验一致,但它揭示了新的不良事件信号.
- 药监数据为ixekizumab的真实安全性提供了宝贵的见解,补充了现有知识.
- 自2023年以来观察到的报告下降值得继续监测.
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