| アブストラクト | BACKGROUND: Concern about post-CAR T-cell lymphomas recently emerged. Analysis of pharmacovigilance data contribute to continuous safety monitoring, especially for newly authorized medicines, like CAR-T therapies. RESEARCH DESIGN AND METHODS: Individual case safety reports (ICSRs) reporting at least one CAR T-cell therapy as a suspect drug were extracted from the Food and Drug Administration Adverse Event Reporting System database up to 6 February 2024. Descriptive and disproportionality analysis were performed. RESULTS: Seventeen ICSRs reported T-cell malignancies associated with CAR T-cell therapy. Gender distribution was similar between females and males, and adult patients accounted for 41.2% of ICSRs. All cases were serious, with 41.2% resulting in death. The most reported Preferred Terms (PTs) for T-cell malignancies was 'T-cell lymphoma' (70.6%). Over 70% of ICSRs reported at least one other adverse event, predominantly gastrointestinal disorders (14.3%). Axicabtagene ciloleucel and tisagenlecleucel were associated with a statistically higher reporting frequency of T-cell lymphoma compared to all other drugs (p-value <0.001, for both). Statistically higher reporting frequencies of 'Haematological malignant tumors' and 'Malignant lymphomas' SMQs emerged when tisagenlecleucel was compared with axicabtagene ciloleucel (p-value <0.001, for both). CONCLUSIONS: Axicabtagene ciloleucel and tisagenlecleucel may be associated with a higher reporting frequency of T-cell lymphoma than other drugs. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2024/12/19 |
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| 投稿者 | Di Napoli, Raffaella; Balzano, Nunzia; Ruggiero, Rosanna; Mascolo, Annamaria; Scavone, Cristina; di Mauro, Gabriella; Capuano, Annalisa |
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| 組織名 | Department of Experimental Medicine, University of Campania "L. Vanvitelli",;Naples, Italy.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples,;Italy.;Department of Life Science, Health, and Health Professions, Link Campus;University, Roma, Italy.;UOC Pharmacy, AORN Santobono-Pausilipon Children's Hospital, Naples, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39696955/ |
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