| アブストラクト | BACKGROUND: CAR-T-associated neurotoxicity is extremely frequent with highly variable clinical presentation. RESEARCH DESIGN AND METHODS: Disproportionality analysis was conducted leveraging the FDA Adverse Event Reporting System (FAERS), covering the period from 1 January 2017, through 31 March 2023. The reporting odds ratio (ROR) and the information component (IC) were utilized to assess the adverse signals in total/individual CAR-T product. The lower limit of the ROR and IC 95% confidence interval (ROR(025) and IC(025)) both exceeding threshold value (1 and 0, respectively) was considered a significant signal. RESULTS: Of the 60, 730 records associated with CAR-T, 11, 037 (18.17%) pertained to neurological events. Tisagenlecleucel exhibited the highest percentage of death (38.02%) and life-threatening (12.90%) outcomes. Notably, it also displayed the broadest distribution of neurotoxicity. Additionally, distinct adverse signals unique to individual CAR-T products were identified. For instance, paraparesis, cerebral hemorrhage, impaired pupillary reflex, Guillain-Barre syndrome, brain death following tisagenlecleucel; dysarthria, orthostatic hypotension, and spinal cord edema after axicabtagene; parkinsonism, Bell's palsy, and cranial nerve paralysis post ciltacabtagene. CONCLUSIONS: Axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel exhibited increased odds of neurotoxicity, with some discrepancies in their characteristics, profiles, and severity. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/10/16 |
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| 投稿者 | Zhai, Yinghong; Yuan, Lei; Fang, Shihua; Liu, Shenglian; Ye, Xiaofei; Shi, Wentao; Cao, Yang; He, Jia; Hu, Fangyuan; Xu, Feng |
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| 組織名 | Clinical Research Unit, Shanghai Ninth People's Hospital, Shanghai Jiao Tong;University School of Medicine, Shanghai, China.;Department of Health Management, Naval Medical University, Shanghai, China.;Department of Infection Management, Fuxing Hospital Affiliated to Capital Medical;University, Beijing, China.;Department of Monitoring, Center for Adverse Drug Reaction Monitoring of Qinghai,;Xining, China.;Department of Health Statistics, Naval Medical University, Shanghai, China.;Clinical Epidemiology and Biostatistics, School of Medical Sciences, Orebro;University, Orebro, Sweden.;Faculty of Health Service, Naval Medical University, Shanghai, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39410883/ |
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