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December 8, 2025Blood

Comparative safety profiles of bispecific T-cell engagers and CAR-T therapies: Real-world insights from the FDA adverse event reporting system database

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Authors

CGCarlos Gálvez

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Overview

Pharmacovigilance analysis reveals differing toxicity profiles for CAR-T and BiTE therapies in lymphoid malignancies, suggesting the need for tailored treatment approaches.

Key Points

  • To compare the safety profiles of CAR-T therapies and bispecific T-cell engagers using real-world data.
  • Conducted a pharmacovigilance analysis using the FAERS database from Q1 2021 to Q4 2024.
  • Identified adverse event reports for FDA-approved CAR-T and BiTE therapies through drug name matching.
  • Calculated disproportionality metrics including proportional reporting ratios and reporting odds ratios.
  • Identified 155,821 AE reports involving BiTEs and 109,001 CAR-T reports in the FAERS database.
  • Neutropenia was significantly higher in BiTEs (20.2%) compared to CAR-T (11.6%).
  • CAR-T therapies demonstrated higher rates of neurotoxicity (36.1% vs 5.2% for BiTEs).
  • Acute kidney injury reported in 7.3% of CAR-T and 4.8% of BiTE-associated reports.

Cite This Study

Carlos Gálvez (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d1cehttps://doi.org/10.1182/blood-2025-8038
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1A post-marketing pharmacovigilance analysis of cardiotoxicities following chimeric antigen receptor T-cell therapy using the FDA adverse event reporting system2025
  2. 2Endocrine adverse events following CAR-T cell therapies: A pharmacovigilance analysis in the real-world setting utilizing the faers database2025
  3. 3Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies : A Real-World FAERS Pharmacovigilance Study2026
  4. 4Real-world comparison of CAR T-cell therapy versus bispecific antibodies in relapsed or refractory multiple myeloma2025 · 1 citations
  5. 5Real-world comparative outcomes of CAR-T cell therapy versus bispecific antibodies in patients with diffuse large B-cell lymphoma2025