Key result
CAR-T therapy was associated with overreporting of cardiovascular and pulmonary adverse events, including tachyarrhythmias (adj.ROR 2.78; 95% CI 2.21-3.51) and cardiomyopathy.
Why the study?
Pivotal trials of CAR-T therapy identified common toxicities but may have been underpowered to detect cardiovascular and pulmonary adverse events.
Does commercial CD19-directed CAR-T therapy increase the risk of cardiovascular and pulmonary adverse events compared to the general adverse event database?
Observational (n=2,657)
Does commercial CD19-directed CAR-T therapy increase the risk of cardiovascular and pulmonary adverse events compared to the general adverse event database?
Odds Ratio: 2.78 (95% CI 2.21–3.51)
CAR-T therapy is associated with significant cardiovascular and pulmonary toxicities, including tachyarrhythmias and cardiomyopathy, highlighting the need for multidisciplinary monitoring.
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Goldman et al. (2021) conducted an observational in Adverse events following CAR-T therapy (n=2,657). Chimeric antigen receptor T-cell (CAR-T) therapy vs. Full FDA adverse event reporting system database was evaluated on tachyarrhythmias (adj.ROR 2.78, 95% CI 2.21-3.51). CAR-T therapy was associated with overreporting of cardiovascular and pulmonary adverse events, including tachyarrhythmias (adj.ROR 2.78; 95% CI 2.21-3.51) and cardiomyopathy.
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