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December 8, 2025Blood

Endocrine adverse events following CAR-T cell therapies: A pharmacovigilance analysis in the real-world setting utilizing the faers database

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Authors

RSRushi ShahTVTANISHA VORADPDakshin Padmanabhan

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Overview

Pharmacovigilance analysis reveals weak signals of endocrine toxicity, particularly hypothyroidism and adrenal insufficiency, in patients receiving CAR-T therapies.

Key Points

  • Identified 56 endocrine adverse events among 55,720 reported for CAR-T therapies, indicating a low incidence rate of 0.1%.
  • Axicabtagene ciloleucel showed highest rates of endocrine toxicities, particularly hypophysitis (n=15) and adrenal insufficiency (n=8).
  • Utilized pharmacovigilance methods and Bayesian disproportionality analysis in Python to evaluate real-world data from FAERS.
  • Highlights the need for endocrine monitoring post-CAR-T treatment due to potential immune-mediated dysfunction.

Cite This Study

Shah et al. (2025) studied this question.

synapsesocial.com/papers/69362f744fa91c937236e2cehttps://doi.org/10.1182/blood-2025-7666
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