Objective:

To analyze the incidence of immune effector cell-associated enterocolitis (IEC-EC) in patients treated with ciltacabtagene autoleucel and other CAR T-cell therapies using the FDA Adverse Event Reporting System (FAERS), highlighting the significance of IEC-EC in the context of CAR T-cell therapies.

Key Findings:

• Only ciltacabtagene autoleucel showed reports of immune-mediated enterocolitis, with 31 cases (ROR 83.65), indicating a significant risk compared to other therapies.
• No reports of IEC-EC were found for other CAR T-cell products, including idecabtagene vicleucel.
• The immunological mechanisms involve CAR-T cell infiltration into gut mucosa, leading to mucosal injury.

Interpretation:

The findings suggest a significant association between ciltacabtagene autoleucel and IEC-EC, highlighting the need for ongoing pharmacovigilance and further investigation into the mechanisms of this adverse event, with potential clinical implications.

Limitations:

• FAERS data may be limited by underreporting, variable report quality, and temporal lags, which could introduce biases in data interpretation.
• Incomplete demographic data and limited case counts hindered sensitivity analyses.

Conclusion:

The study underscores the importance of monitoring IEC-EC in patients treated with ciltacabtagene autoleucel and suggests potential differences in toxicity profiles among CAR T-cell therapies, emphasizing the need for further research.