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July 2, 2026CancersOpen Access

Real-World Dermatologic Adverse Events of CAR T-Cell Therapy: A Decade-Wide Disproportionality Analysis of the FDA Adverse Event Reporting System

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Authors

MMManideepa MajiSMSaikat MandalADArkadeep Dhali

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Overview

Randomized trial evaluates dermatologic adverse events in CAR T-cell therapy, suggesting reduced reporting rates.

Key Points

  • This research aims to characterize the dermatologic safety profile of CAR T-cell therapy by analyzing adverse events reported to the FDA.
  • Analyzed 8,431,841 FDA Adverse Event Reporting System reports from 2016 Q3 to 2026 Q1.
  • Identified seven CAR T-cell products and monitored various dermatologic adverse events.
  • Employed multivariable models to adjust for demographics and other treatment variables.
  • Identified 996,654 dermatologic adverse events, with 425 cases associated with CAR T-cell therapy.
  • CAR T-cell exposure led to a reduced reporting odds for dermatologic events (adjusted OR 0.13, 95% CI 0.09–0.20).
  • Severe dermatologic reports often overlapped with cytokine release syndrome; proxies influenced reporting.

Cite This Study

Maji et al. (2026) studied this question.

synapsesocial.com/papers/6a45ffd19ed13430313100eahttps://doi.org/10.3390/cancers18132128
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