Cardinal Health Specialty Solutions, Cardinal Health, Dublin, OH 43017, USA.
Immunotherapy. 2020 Oct;12(14):1077-1082. doi: 10.2217/imt-2020-0161. Epub 2020 Aug 18.
To characterize real-world neurological adverse events (AEs) associated with chimeric antigen receptor T-cell therapies in patients with refractory/relapsed large B-cell lymphomas. Postmarketing case reports from the US FDA AEs reporting system involving axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for large B-cell lymphomas were analyzed. Of 804 AE cases identified (637 axi-cel, 167 tisa-cel), 428 (67%) of axi-cel cases and 43 (26%) of tisa-cel cases reported neurological AEs. Compared with cases without neurological AEs, significant associations were observed between neurological AEs and use of axi-cel, age ≥65 years, and the outcome of hospitalization. Neurological AEs were common with chimeric antigen receptor T-cell therapy in the real world and largely reflected those reported in clinical trials.
为了描述在接受嵌合抗原受体 T 细胞疗法治疗的难治/复发大 B 细胞淋巴瘤患者中与该疗法相关的真实世界神经不良事件（AE）。分析了来自美国 FDA 不良事件报告系统的上市后病例报告，涉及 axicabtagene ciloleucel（axi-cel）和 tisagenlecleucel（tisa-cel）治疗大 B 细胞淋巴瘤的病例。在 804 例 AE 病例中（637 例 axi-cel，167 例 tisa-cel），428 例（67%）axi-cel 病例和 43 例（26%）tisa-cel 病例报告了神经 AE。与无神经 AE 病例相比，神经 AE 与 axi-cel 的使用、年龄≥65 岁以及住院结局之间存在显著关联。在真实世界中，嵌合抗原受体 T 细胞治疗会引发常见的神经 AE，且这些 AE 很大程度上反映了临床试验中的报告结果。
