与JAK抑制剂相关的胃肠道穿孔:FDA不良事件报告系统的不成比例分析
Adam Goldman1,2,3, Emanuel Raschi4, Amit Druyan1,5
1Department of Internal Medicine, Sheba Medical Center, Ramat-Gan, Israel.
United European gastroenterology journal
|December 30, 2024
概括
与服用生物药物的患者相比,服用氏激酶 (JAK) 抑制剂的类风湿性关节炎患者的胃肠道穿孔增加. 同时使用类固醇或NSAID进一步增加了这种风险,需要仔细监测.
科学领域:
- 药物监督和药物安全研究.
- 风湿病学和免疫学.
- 胃肠病学和不良事件分析.
背景情况:
- 风湿性关节炎 (RA) 患者接受Janus激酶 (JAK) 抑制剂治疗,在临床试验中发现罕见的胃肠道穿孔.
- 在接受JAK抑制剂治疗的RA患者中,大规模的营销后数据对于调查这种严重不良事件至关重要.
研究的目的:
- 评估RA患者中JAK抑制剂和胃肠道穿孔之间的关联.
- 将使用JAK抑制剂的胃肠道穿孔风险与生物修饰性抗风湿药物 (bDMARDs) 的风险进行比较.
主要方法:
- 使用FDA不良事件报告系统进行回顾性药监测研究 (2014年7月至2023年9月).
- 在RA患者中,JAK抑制剂和bDMARD之间的胃肠道穿孔报告率的比较.
- 使用多变量逻辑回归计算调整报告几率比率 (adj.ROR).
主要成果:
- 在RA患者中,与bDMARD相比,JAK抑制剂与更高的胃肠道穿孔报告相关 (adj.ROR = 1.98).
- 同时使用类固醇或NSAID显著增加了穿孔报告风险 (adj.ROR = 2.82).
- 所有的JAK抑制剂 (托法西提尼布,乌帕达西提尼布,巴里西提尼布) 在胃肠道穿孔方面都显示出显著的安全信号.
结论:
- 与bDMARDs相比,所有JAK抑制剂都与RA患者的胃肠道穿孔报告增加有关.
- 临床医生应保持高度的意识和监测胃肠道穿孔在RA患者治疗JAK抑制剂.
- 需要更多关于炎症性肠病 (IBD) 患者的数据,但建议谨慎.
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