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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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Cardiovascular Events Associated with Chimeric Antigen Receptor T Cell Therapy: Cross-Sectional FDA Adverse Events

Avirup Guha1, Daniel Addison2, Prantesh Jain3

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Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation
|September 23, 2020
PubMed
Summary

Cardiovascular adverse events (CVEs) are a significant concern in CAR T-cell therapy, with arrhythmias being most common. Neurotoxicity and cytokine release syndrome (CRS) increase the risk of CVEs and mortality in patients undergoing CAR T-cell treatment.

Keywords:
Cardio-oncologyCardiovascular eventsChimeric antigen receptor T cellsFAERSHierarchical clusteringICANS

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Area of Science:

  • Oncology
  • Immunology
  • Cardiology

Background:

  • Chimeric antigen receptor (CAR) T-cell therapy is an approved treatment for certain leukemias and lymphomas.
  • While CAR T-cell therapy shows promise, cardiovascular adverse events (CVEs) have been noted in smaller studies, necessitating larger-scale investigations.
  • The Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) is a valuable resource for identifying and analyzing post-market drug safety data.

Purpose of the Study:

  • To investigate the incidence and characteristics of CVEs associated with CAR T-cell therapy using a large-scale database.
  • To identify factors associated with the occurrence of CVEs in patients receiving CAR T-cell therapy.
  • To assess the impact of CVEs on mortality rates in patients undergoing CAR T-cell therapy.

Main Methods:

  • Utilized the FDA FAERS database to extract adverse event (AE) reports for CAR T-cell therapies (tisagenlecleucel and axicabtagene ciloleucel) from 2017 to 2019.
  • Excluded reports with missing age and sex data.
  • Classified CVEs into arrhythmias, heart failure (HF), myocardial infarction (MI), and other categories. Employed logistic regression and hierarchical clustering to identify associated factors.

Main Results:

  • A total of 996 AEs were reported, with 19.7% classified as CVEs. The most frequent CVE was arrhythmia (77.6%), followed by HF (14.3%).
  • Patients experiencing CVEs had a higher mortality rate (30.1%) compared to the overall AE cohort (21.1%).
  • Neurotoxicity was significantly associated with CVEs (OR, 1.76; P=.004). When both CVE and cytokine release syndrome (CRS) were present, neurotoxicity was the most common non-cardiac AE.

Conclusions:

  • CVEs, particularly arrhythmias, are a notable safety concern in CAR T-cell therapy, associated with increased mortality.
  • The presence of neurotoxicity and/or cytokine release syndrome (CRS) should alert clinicians to a heightened risk of cardiovascular complications.
  • Vigilance for cardiovascular events is crucial in patients receiving CAR T-cell therapy, especially those with concurrent neurotoxicity or CRS.