Infections Post-CAR-T Therapy: A Real-World Pharmacovigilance Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Clin Ther. 2026 Apr 7:S0149-2918(26)00075-5. doi: 10.1016/j.clinthera.2026.03.014. Online ahead of print.

ABSTRACT

PURPOSE: This study aims to characterize the spectrum, timing, and risk factors of infections following chimeric antigen receptor T-cell (CAR-T) therapy using real-world data.

METHODS: We extracted reports of infection-related AEs associated with CAR-T therapy from the Food and Drug Administration Adverse Event Reporting System database from Q1 2017 to Q4 2024. Disproportionality analyses were conducted using to identify significant infection signals. Time-to-onset (TTO) analysis and multivariate logistic regression were performed to evaluate temporal patterns and risk factors.

FINDINGS: Among 50,386 CAR-T-related AE reports, 3467 (7%) were infection-related, involving 2238 patients (15.7% of recorded CAR-T recipients). The fatality rate among infection cases was 41%. Significant infection signals were detected for five of six CAR-T products (all except ide-cel). Tisa-cel showed the strongest signal (reporting odds ratio = 1.76, IC025 = 0.58). Most infections (74.7%) occurred within 30 days postinfusion, with a median TTO of 5 days. Viral infections occurred later than bacterial ones. Multivariate analysis identified tisa-cel (OR = 1.34), cilta-cel (OR = 1.62), neutropenia (OR = 2.65), and hypogammaglobulinemia (OR = 3.45) as significant risk factors for infection.

IMPLICATIONS: This large-scale real-world analysis confirms a significant association between CAR-T therapy and several infections. Most infections occur within the first month post-treatment. Product-specific differences in infection profile and timing underscore the need for tailored prophylactic and monitoring strategies. These findings highlight the critical importance of vigilant infection management in CAR-T recipients to reduce nonrelapse mortality.

PMID:41951449 | DOI:10.1016/j.clinthera.2026.03.014