报告至 FAERS 数据库的 CAR-T 细胞免疫治疗不良事件：聚焦血细胞减少

Chimeric antigen receptor (CAR) T-cell therapy presents a promising treatment for hematologic malignancies, displaying high efficacy but not being exempt from toxicity. In this observational study, we assessed adverse events (AEs) reported to the Food and Drug Adverse Event Reporting System (FAERS) including any of the six approved CAR T-cell therapies. A total of 5249 reports mentioning a CAR T-cell as a suspect product were retrieved from the FAERS database, containing a total of 24333 AEs, of which 3236 (13. 3%) were cytopenias. The highest number of AEs mentioned by the report was observed for tisagenlecleucel (mean = 6. 7), with the lowest for ciltacabtagene (mean = 1. 3).

Among all reports, hematopoietic leukopenia was the most frequently reported AEs ( n = 1386, 5. 7%), with hematopoietic erytropenia the least reported ( n = 291, 1. 2%). Tisagenlecleucel showed a high reporting odds ratio for hematopoietic erythropenia (27. 28, 95%CI 14. 04-53. 00), leukopenia (4. 04, 95%CI 3. 52-4. 64), and thrombocytopenia (4. 01, 95%CI 3.

19-5. 03). Cytopenias represent one of the most frequently reported AEs in FAERS, a CAR T-cell therapy is indicated, with haematopoetic leukopenia being the most common. When comparing different CAR-T cell therapies, the cytopenias' reporting odds ratio was particularly high for tisagenlecleucel, especially in relation to hematopoietic erythropenia .