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使用FDA不良事件报告系统对炎症性肠病中与upadacitinib相关的不良事件的不成比例分析
Shiyi Wang1, Xiaojian Wang2, Jing Ding1
1Department of Gastroenterology, Ningbo Hospital of Traditional Chinese Medicine, Affiliated to Zhejiang Chinese Medical University, Ningbo, China.
乌帕达西丁 (Upadacitinib) 是一种Janus激酶抑制剂,在炎症性肠病中显示出有效性,但存在潜在的安全问题. 这项研究确定了患者常见和意想不到的不良事件 (AE),突出了进一步临床研究的需要.
科学领域:
- 药物监督 药物监督 药物监督
- 胃肠病学 胃肠病学
- 药品安全 药品安全
背景情况:
- 乌帕达西替尼 (Upadacitinib) 是一种用于中度至重度性结肠炎和克罗恩病的雅努斯酶抑制剂.
- 它的有效性已在对TNF抗体无反应的患者中确立,但在广泛人群中长期安全性数据有限.
- 本研究使用现实世界的数据调查与upadacitinib相关的不良事件 (AE).
研究的目的:
- 评估在患有炎症性肠病 (IBD) 的患者中使用upadacitinib的安全性.
- 使用营销后监测数据,识别与上巴西替尼治疗相关的潜在不良事件 (AE).
- 将现实世界AE信号与已知的临床试验结果进行比较.
主要方法:
- 在美国FDA不良事件报告系统 (FAERS) 数据上使用了不成比例分析 (PRR,ROR,BCPNN,EBGM).
- 分析了7,037,004份不良事件报告,重点关注1,917例,其中upadacitinib是IBD的疑似药物.
- 根据年龄进行了子组分析.
主要成果:
- 常见的副作用包括,产品残留物和血,与临床试验一致.
- 发现了一些意想不到的不良事件,如粉红疹,直肠炎和多.
- 老年患者的肺栓塞,白内障和败血症的发病率较高;年轻人报告更多的和鼻炎.
- 大多数副作用发生在治疗开始后3个月内.
结论:
- 结果证实了已知的副作用,并建议在IBD中对upadacitinib产生新的AE信号.
- 强调持续对upadacitinib进行药物监测的重要性.
- 建议进行前性研究,以验证这些现实世界的安全发现.
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