| アブストラクト | BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapy, including axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel), has demonstrated significant efficacy in treating refractory or relapsed diffuse large B-cell lymphoma and B-cell acute lymphoblastic leukemia. Though adverse events such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are well characterized, the dermatologic adverse event (DAE) profile is less thoroughly described. OBJECTIVES: This study aims to provide the first comprehensive analysis of DAEs associated with axi-cel and tisa-cel using real-world data from the FDA Adverse Event Reporting System (FAERS) database. STUDY DESIGN: FAERS database reports citing axi-cel or tisa-cel in patients aged 16 years or older were included, excluding duplicate reports and off-label indications. Disproportionality analysis by reporting odds ratio (ROR) was utilized to detect increased reporting of drug-adverse event combinations. RESULTS: Of the 11,256,845 reports in the FAERS database, 5,559 identified CAR-T therapy as the primary suspected drug. After exclusions, 3,666 reports were analyzed (2,168 for axi-cel and 1,498 for tisa-cel). Among these, 2.7% of axi-cel and 5.1% of tisa-cel cases reported DAEs. There was a statistically significant increased reporting of 2 DAE groups associated with CAR-T therapy: severe cutaneous eruptions (ROR 5.18, 95% CI 1.29, 20.76) and vascular cutaneous (ROR 2.91, 95% CI 1.51, 5.60). The median time to DAE onset was 3 days after CAR T-cell infusion. Death was a reported outcome in 11.9% and 13.0% of axi-cel and tisa-cel DAE cases, respectively, and in 50% and 25% of severe cutaneous eruptions and vascular cutaneous cases, respectively. CONCLUSIONS: This study reveals a significantly increased reporting rate of severe cutaneous eruptions and vascular cutaneous DAEs associated with CAR-T therapy, with both event groups associated with high mortality. These results emphasize the importance of monitoring dermatologic toxicities in clinical practice to ensure timely identification and management of potentially severe adverse events. |
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| ジャーナル名 | Transplantation and cellular therapy |
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| Pubmed追加日 | 2024/7/1 |
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| 投稿者 | Storgard, Ryan; Dusza, Stephen; Shouval, Roni; Scordo, Michael; Markova, Alina |
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| 組織名 | Dermatology Service, Department of Medicine, Memorial Sloan Kettering Cancer;Center, New York, New York.;Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering;Cancer Center, New York, New York.;Weill Cornell Medical College, Cornell University, New York, New York.; Bone;Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering;Center, New York, New York.; Weill Cornell Medical College, Cornell University,;New York, New York.. Electronic address: markovaa@mskcc.org. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38945480/ |
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