| アブストラクト | During pre-approval clinical trials, the safety of axi-cel, a second-generation CAR-T-cell therapy directed against CD19, which dramatically improved the prognosis of intractable B-cell lymphomas, has been investigated only in about 400 patients. Therefore, additional information on this issue is urgently needed. In the present paper, we evaluated the 2905 ICSRs with axi-cel as the suspected drug that had been uploaded in the EudraVigilance database from 1 January 2018 to 31 December 2022. About 80% of the reported adverse events were serious, and about 20% of them did not fully resolve or caused death. The adverse events most-frequently reported were Nervous system disorders (25.6%) and, among them, immune-effector-cell-associated neurotoxicity syndrome, followed by Immune system disorders (23.1%), General disorders and administration site conditions (12.0%), Blood and lymphatic system disorders (7.2%), and Infections and infestations (5.8%). Disproportionality analysis showed that the frequency of reported adverse events related to the nervous system was higher with axi-cel than with the other approved CAR-T-cells, except brexu-cel. In conclusion, real-world pharmacovigilance data showed that nervous system and immune system disorders are the adverse events most reported in axi-cel-related ICSRs and suggest that axi-cel could be more neurotoxic than other CAR-T-cells. |
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| ジャーナル名 | Biomedicines |
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| 投稿日 | 2023/8/26 |
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| 投稿者 | Rafaniello, Concetta; Liguori, Valerio; Zinzi, Alessia; Gaio, Mario; Falco, Angela; Di Costanzo, Luigi; Gargano, Francesca; Trimarco, Valentina; Cataldi, Mauro; Capuano, Annalisa |
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| 組織名 | Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138;Naples, Italy.;Section of Pharmacology "L. Donatelli", Department of Experimental Medicine,;University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.;Section of Pharmacology, Department of Neuroscience, Reproductive Sciences and;Dentistry, Federico II University of Naples, Via Sergio Pansini 5, 80131 Naples,;Italy.;Department of Anesthesia and Resuscitation, Biomedical Campus University of Rome,;00128 Rome, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37626659/ |
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