基于来自EudraVigilance数据库的自发报告,对阿克西卡巴丁基尼基洛卢塞尔安全性的药监测研究
Concetta Rafaniello1,2, Valerio Liguori1,2, Alessia Zinzi1,2
1Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy.
现实世界的数据显示,轴细胞 (axicabtagene ciloleucel) CAR-T疗法与频繁的严重不良事件有关,特别是神经系统和免疫系统疾病. 一些事件没有解决或是致命的,表明与其他CAR-T细胞相比,潜在的神经毒性.
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:
- 艾克西卡巴丁基可乐塞尔 (axi-cel) 是一种针对CD19的CAR-T疗法,可改善B细胞淋巴瘤的治疗结果.
- 轴细胞的预审批安全数据涉及有限的患者数量 (约400人).
- 迫切需要真实世界的安全数据在轴心电池存在.
研究的目的:
- 通过使用现实世界的数据来评估axi-cel的安全性.
- 识别和量化与轴细胞疗法相关的不良事件.
主要方法:
- 从EudraVigilance (2018年1月至2022年12月) 对2905个轴心细胞的ICSR进行分析.
- 评估不良事件类型,严重程度和结果.
- 不成比例分析比较轴细胞与其他CAR-T细胞.
主要成果:
- ~80%报告的不良事件是严重的; ~20%的不解决或致命的结果.
- 最常见的不良事件:神经系统障碍 (25.6%,包括神经毒性综合征),免疫系统障碍 (23.1%).
- 与其他CAR-T细胞相比,轴细胞的神经系统事件频率高于其他CAR-T细胞,除了乳细胞.
结论:
- 现实世界的药监数据强调神经系统和免疫系统疾病作为主要的轴细胞不良事件.
- 研究结果表明,与其他CAR-T细胞疗法相比,轴细胞可能表现出更大的神经毒性.
- 需要持续监测轴心安全性.
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