免疫检查点抑制剂和硬皮病:来自欧洲药监数据库的数据
Maria Maddalena Nicoletti1, Erminia Crisci2, Vincenzo Cosenza3
1Department of Precision Medicine, University of Campania "Luigi Vanvitelli", 80138, Naples, Italy.
Drugs - real world outcomes
|November 1, 2023
概括
免疫检查点抑制剂 (ICI) 可以导致严重的自身免疫性疾病 - - 硬皮病. 这项研究分析了来自欧洲安全报告的70起病例,发现它发生在各种ICI中,主要是pembrolizumab和nivolumab.
科学领域:
- 在瘤学瘤学.
- 免疫学 免疫学 免疫学
- 皮肤病学 皮肤病学
背景情况:
- 免疫检查点抑制剂 (ICI) 与免疫相关的不良药物反应 (irADRs) 有关.
- 由ICI引起的皮肤毒性,包括硬质皮质,是显著的irADRs.
- 硬化皮质及其模仿物可以在ICI治疗期间引起相当大的发病率.
研究的目的:
- 在接受ICI的患者中分析硬皮病的发生.
- 描述来自ICI诱导的硬化成体的个体病例安全报告 (ICSR) 的数据.
- 为了研究作为一种irADR的硬化肌病的临床意义.
主要方法:
- 从欧洲自发报告系统 (EudraVigilance) 获取了70个ICSR,直到2023年2月.
- 识别了至少有一个ICI作为可疑药物和与硬化皮肤相关的术语的ICSR.
- 分析了疑似药物,患者人口统计数据,并报告了结果.
主要成果:
- 布利祖马布 (41例) 和尼沃卢马布 (25例) 是最常被怀疑的ICI.
- 结核病例主要是严重的,影响了没有显著的性别差异的成年患者.
- 报告最多的术语是硬化症和形态,主要是有利的结果.
结论:
- ICI诱导的硬质皮是一种严重的IRADR,需要注意.
- 需要进一步进行高质量的临床研究来估计这些事件的影响.
- 鉴于这些疗法在癌症治疗中越来越多地使用,了解ICI诱导的硬化皮肤至关重要.
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