与多发性骨髓瘤T细胞激活疗法相关的神经学不良事件:药物监测研究
Muhammad Atif Khan1, Faiza Humayun Khan2, Sohaib Irfan3
1Internal Medicine, University of Kansas Medical Center, Kansas City, USA.
Cureus
|August 18, 2025
概括
神经学不良反应 (NAE) 与多发性骨髓瘤的T细胞吸引剂 (TCE) 疗法是常见的. 塔尔基塔马布 (TQ) 呈现了最高的NAE报告率,而特克利斯塔马布 (TL) 呈现了最多的NAE病例和死亡,需要仔细监测.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
背景情况:
- 复发性/耐药性多发性骨髓瘤 (RRMM) 带来了治疗挑战.
- 像特克利斯塔马布 (TL),塔尔克塔马布 (TQ) 和埃拉拉纳塔马布 (ER) 这样的T细胞参与剂 (TCE) 疗法显示出有希望但带有风险.
- 神经学不良影响 (NAE) 是TCEs的重要关注点.
研究的目的:
- 评估TL,TQ和ER的频谱,报告模式和NAE在TL,TQ和ER中的可能性.
- 为了比较RRMM中三个领先的TCE的神经安全概况.
主要方法:
- 2024年FDA不良事件报告系统 (FAERS) 数据库的回顾性分析.
- 使用描述性统计和不成比例分析 (ROR,EBGM) 来评估NAE.
- 包括1921个与TL,TQ和ER相关的不良事件总数.
主要成果:
- 在所有报告的不良事件中,NAE占27.6% (530例).
- 德基利斯塔马布 (TL) 的NAE病例数量最高 (46.79%),而塔尔基塔马布 (TQ) 的报告比例最高 (39.2%).
- 塔尔基塔马布 (TQ) 与NAE的关联性最高 (ROR:2.13),埃拉拉纳塔马布 (ER) 最低 (ROR:0.49),而特克利斯塔马布 (TL) 没有强烈的信号 (ROR:0.85).
结论:
- 在RRMM中,特别是TL中,NAE是TCE毒性概况的重要组成部分.
- 在所有药物中报告了免疫效应细胞相关的神经毒性综合征 (ICANS) 和非ICANS NAE.
- 调查结果强调了需要主动的神经监测和研究预测标志物的必要性,以改善TCE管理.
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