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对乌帕达西提尼布的不良事件评估:基于FAERS数据库的药监测研究
Jiayu Yuan1, HongXia Lu1, Xulei Zuo1
1Key Laboratory of Environmental Medicine Engineering, Ministry of Education, School of Public Health, Southeast University, Nanjing, Jiangsu, China.
Pharmacoepidemiology and drug safety
|October 10, 2024
概括
使用FAERS数据评估了Upadacitinib (JAK抑制剂) 的安全性. 确定了特定于性别的不良事件,突出了针对自身免疫疾病患者进行量身定制监测的必要性.
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
- 药品安全 药品安全
背景情况:
- 乌帕达西替尼 (Upadacitinib) 是一种被批准用于治疗自身免疫性疾病的Janus激酶 (JAK) 抑制剂.
- 现实世界的安全数据对于了解药物不良事件至关重要.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 数据评估与upadacitinib相关的不良事件.
- 在upadacitinib的不良事件概况中识别潜在的性别特异性模式.
主要方法:
- 对2019年第三季度至2023年第四季度的FAERS数据的分析.
- 使用四个统计指标 (ROR,PRR, BCNN,EBG) 的不成比例分析.
- 根据患者的性别对不良事件的分层分析.
主要成果:
- 分析了超过680万份不良事件报告,其中有37700份主要怀疑的阿帕达西提尼布报告.
- 在24个器官系统类别和246个首选术语中确定了重大不良事件.
- 在不良事件中观察到性别特异性差异,男性患有普遍的肌肉骨和皮肤疾病,女性患有肌肉骨问题,感染和异常的实验室测试.
结论:
- 现实世界的证据表明,upadacitinib的性别特异性不良事件概况.
- 对基于性别的不良事件的监测对于upadacitinib的安全性至关重要.
- 建议进行进一步的前性研究,以验证这些药监发现.
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