CAR-T therapy pulmonary adverse event profile: a pharmacovigilance study based on FAERS database (2017-2023)

Area of Science:

• Oncology
• Immunotherapy
• Pharmacovigilance

Background:

• Chimeric antigen receptor T-cell (CAR-T) therapy is a significant advancement in cancer treatment approved by the FDA in 2017.
• While effective, CAR-T therapy is associated with potentially life-threatening adverse pulmonary events (PAEs).

Purpose of the Study:

• To investigate the incidence and characteristics of PAEs associated with CAR-T cell therapy.
• To identify specific CAR-T products and their correlation with distinct pulmonary adverse events.

Main Methods:

• Retrospective analysis of the FDA Adverse Event Reporting System (FAERS) database from 2017 to 2023.
• Utilized statistical methods including Reporting Odds Ratio and Empirical Bayes Geometric Mean to assess CAR-T therapy and PAE associations.
• MedDRA 26.1 coding was employed for adverse event classification.

Main Results:

• Out of 9,400 reported adverse events for CAR-T therapies, 10% (940) were identified as PAEs.
• Hypoxia (344 cases) and respiratory failure (127 cases) were the most frequent PAEs.
• Tisa-cel was linked to severe events like respiratory failure and hypoxia, while Axi-cel correlated with hypoxia and tachypnea. Most PAEs occurred within 30 days post-treatment, with Tisa-cel showing the highest fatality rate (43.6%).

Conclusions:

• CAR-T cell therapy is associated with significant pulmonary adverse events including hypoxia, respiratory failure, pleural effusion, and atelectasis.
• These findings underscore the clinical importance of monitoring for PAEs in patients undergoing CAR-T therapy.
• Further research and clinical vigilance are warranted to manage and mitigate these risks.