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与化学抗原受体T细胞治疗相关的皮肤不良事件:FDA报告系统的药监测分析

Ryan Storgard¹, Stephen Dusza¹, Roni Shouval²

¹Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Transplantation and cellular therapy

|June 30, 2024

概括

化学抗原受体T细胞 (CAR-T) 治疗与严重皮肤反应和血管问题的报告增加有关. 这些皮肤学不良事件 (DAE) 需要仔细监测,因为它们的死亡风险很高.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药物监督药物监督药物监督

背景情况:

化学抗原受体T细胞 (CAR-T) 疗法,包括axicabtagene ciloleucel (axi-cel) 和tisagenlecleucel (tisa-cel),在某些血液恶性瘤中具有显著的疗效.
虽然细胞因子释放综合征 (CRS) 和神经毒性是已知的不良事件,但与CAR-T疗法相关的皮肤学不良事件 (DAE) 不太了解.
现实世界的数据分析对于在临床试验环境之外全面了解CAR-T相关的毒性至关重要.

研究的目的:

进行与轴细胞和 tisa 细胞 CAR-T 疗法相关的皮肤学不良事件 (DAE) 的首次全面分析.
利用来自FDA不良事件报告系统 (FAERS) 的现实数据来识别和量化DAE报告模式.
评估CAR-T治疗与特定类型的DAE之间的关联,包括其严重程度和结果.

主要方法:

从FAERS数据库中对16岁或以上接受轴细胞或tisa细胞的患者的非识别报告的分析.
排除重复报告和非标签说明,以确保数据完整性.
使用报告几率比率 (ROR) 进行不成比例分析,以检测特定药物不良事件组合的统计显著增加.

主要成果:

在3666个分析的CAR-T治疗报告中,2.7%的轴细胞和5.1%的tisa细胞包括DAE.
与CAR-T疗法相关的严重皮肤喷发 (ROR 5.18) 和血管皮肤事件 (ROR 2.91) 的统计学上显著增加报告.
DAE发病的中位时间为输注后3天,严重皮肤喷发 (50%) 和血管皮肤事件 (25%) 报告的死亡率高.

结论:

卡特-T疗法与严重皮肤喷发和血管皮肤皮肤不良事件报告率显著增加有关.
这些确定的DAE与大量的死亡率有关,这强调了它们的临床意义.
在接受CAR-T治疗的患者中,定期的皮肤病监测对于早期检测和管理可能严重的不良事件至关重要.

关键词:

不良事件是不良事件.在CART-T中,我们可以使用CAR-T.公平的人是公平的.美国食品药品监督管理局 FDA FDA

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