| アブストラクト | BACKGROUND: Chimeric antigen receptor T (CAR T) cell therapies have emerged as a valuable treatment modality for patients with plasma cell disorders. As the population of patients receiving CAR T therapies grows, identification and management of associated rare toxicities have become increasingly crucial. OBJECTIVE: To identify safety signals associated with commercial anti-B-cell maturation antigen (BCMA) CAR T therapies using the Food and Drug Administration Adverse Event Reporting System (FAERS). STUDY DESIGN: This is a cross-sectional analysis of the adverse events (AE) reports associated with ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel), submitted to FAERS between January 2021 and December 2023. AE frequencies were summarized using descriptive statistics, and safety signals were explored by measuring the reporting odds ratio (ROR) compared to control groups. RESULTS: Among 4,472,782 unique FAERS reports, 1,496 involved BCMA-directed CAR-T therapies. AEs reported more frequently included immune associated conditions and neurological disorders. Neurotoxicity associated with cilta-cel predominantly manifested as cranial nerve palsies, parkinsonism, acute and chronic polyneuropathies, while ide-cel neurotoxicity presented as confusion, disorientation, seizures, balance disturbances, and tremors. In cilta-cel reports, other safety signals included Guillain-Barre syndrome (ROR: 17.1, 95% CI 6.1 -47.5), intracranial hemorrhage and cerebrovascular accidents (ROR: 2.9, 95% CI 1.8 -4.8), haemophilus infections (ROR: 34.2, 95% CI 11.8-98.9) and cytomegalovirus infections (ROR: 3.9, 95% CI 1.6 -9.5). For ide-cel, new signals included parkinsonism (ROR: 13.7, 95% CI 5.5-34.5), acute and chronic sarcoidosis (ROR: 197.1, 95% CI 32.9 -1180.1), ventricular arrhythmias, and cardiac arrest (ROR: 3.9, 95% CI 2.1-7.3). CONCLUSION: This data provides a comprehensive insight into the safety profiles of the commercial BCMA-directed CAR T therapies, underscoring the importance of vigilant post-marketing surveillance to mitigate potential risks. |
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| ジャーナル名 | Transplantation and cellular therapy |
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| Pubmed追加日 | 2024/12/14 |
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| 投稿者 | Ellithi, Moataz; Elsallab, Magdi; Lunning, Matthew A; Holstein, Sarah A; Sharma, Smriti; Trinh, Jonathan Q; Ma, Jihyun; Maus, Marcela V; Frigault, Matthew J; D'Angelo, Christopher R |
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| 組織名 | Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center,;Omaha, NE, USA; Department of Internal Medicine, University of Nebraska Medical;Center, Omaha, NE, USA; Adult Bone Marrow Transplantation Service, Memorial Sloan;Kettering Cancer Center, New York, New York, USA.;Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA,;USA; Cellular Immunotherapy Program, Mass General Cancer Center, and Department;of Medicine, Harvard Medical School, Boston, MA, USA. Electronic address:;melsallab@mgh.harvard.edu.;Center, Omaha, NE, USA.;Department of Internal Medicine, University of Nebraska Medical Center, Omaha,;NE, USA.;Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE,;USA.;Cellular Immunotherapy Program, Mass General Cancer Center, and Department of;Medicine, Harvard Medical School, Boston, MA, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39672542/ |
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