Updated insights on cardiac risks of CD19-directed chimeric antigen receptor T-cell therapy: a pharmacovigilance study.
Yinghong ZhaiFangyuan HuBorui ZhuJinfang XuXiaojing GuoWentao ShiXiang ZhouYi ZhengXiao XuXiaofei YeJia HeFeng XuPublished in: Immunotherapy (2023)
Aim: Comprehensively characterize the cardiotoxicity of CD19-directed chimeric antigen receptor T-cell (CAR-T) products. Materials & methods: Data between 2017 and 2021 in the US FDA's Adverse Event Reporting System database were utilized. Disproportionality was measured using reporting odds ratio and information component. Hierarchical clustering analysis was performed to explore the relationships among cardiac events. Results: Tisagenlecleucel exhibited the highest percentage of death (53.24%) and life-threatening (13.39%) outcomes. Axicabtagene ciloleucel and tisagenlecleucel were equal in the number of positive signals (n = 15), while the former had excessive reporting of several cardiac events versus the latter, such as atrial fibrillation, cardiomyopathy, cardiorenal syndrome and sinus bradycardia. Conclusion: Several cardiac risks should be considered for CAR-T treatment and these events might vary in frequency and severity following different CAR-T agents.
Keyphrases
- adverse drug
- left ventricular
- atrial fibrillation
- heart failure
- electronic health record
- stem cells
- type diabetes
- coronary artery disease
- human health
- adipose tissue
- risk assessment
- big data
- weight gain
- percutaneous coronary intervention
- deep learning
- left atrial
- single cell
- health information
- acute coronary syndrome
- skeletal muscle
- catheter ablation
- oral anticoagulants
- rna seq
- cell therapy