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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

Retrospective pharmacovigilance analysis identifies endocrine toxicities in CAR-T therapies, suggesting increased monitoring is needed.

Key Points

  • This analysis aims to characterize endocrine adverse events associated with CAR-T cell therapies using real-world data.
  • Conducted a retrospective pharmacovigilance analysis of FAERS data from 2017 to 2025.
  • Defined endocrine adverse events using MedDRA preferred terms across various endocrine axes.
  • Employed Bayesian disproportionality analysis and Hierarchical Bayesian Models for signal detection.
  • Among 55,720 adverse events, 56 (0.1%) were endocrine-related.
  • Axicabtagene ciloleucel showed the highest incidence of endocrine adverse events.
  • Key adverse events included hypophysitis, hypothyroidism, and adrenal insufficiency with signals detected for pituitary and thyroid 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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Also Consider

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  1. 1Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies: A Real-World FAERS Pharmacovigilance Study2026 · 1 citations
  2. 2Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies : A Real-World FAERS Pharmacovigilance Study2026
  3. 3Adverse Events of CD19- and BCMA-Directed Chimeric Antigen Receptor T-Cell Therapy: An Analysis of the FDA Adverse Events Database2026
  4. 4Spectrum and prognosis of CAR-T-related endocrine toxicity: glucose/calcium dysregulation, pituitary axis disorders, and overlap with CRS2026 · 1 citations
  5. 5Comparing the Differences in Adverse Events among Chimeric Antigen Receptor T-Cell Therapies: A Real-World Pharmacovigilance Study2024 · 12 citations