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Immune checkpoint inhibitor-related gastrointestinal adverse events: a disproportionality analysis based on the FAERS
Yuye Gao1, Junpeng Pei1, Dengbo Ji1
1State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Unit III, Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, China.
Background:
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment but are frequently linked to gastrointestinal immune-related adverse events, which can severely affect patient outcomes.
Research Design And Methods:
We conducted a retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (2011-2024). Disproportionality analyses (ROR, PRR, BCPNN, MGPS) identified gastrointestinal adverse events (AEs) associated with ICIs across pan-cancer populations, while multivariable logistic regression and Bayesian network modeling were used to examine influencing factors.
Results:
A total of 85 distinct gastrointestinal toxicities were identified and categorized as ICI-related gastrointestinal AEs (GI AEs). Substantial variation in ICI-related GI AE profiles was observed across different ICI regimens, with anti-CTLA-4 demonstrating the highest toxicity (ROR = 17.76 [16.88-18.68]). Logistic regression and Bayesian network analyses indicated that disease stage, concurrent targeted therapies, and ICI type significantly influenced the risk of developing ICI-related GI AEs. Patients with gastric variceal hemorrhage exhibited the highest mortality rate (63.64%).
Conclusions:
Our pharmacovigilance analysis reveals a high risk of gastrointestinal adverse events with ICI therapy, especially anti-CTLA-4. Stage IV disease, concurrent targeted therapies, and anti-CTLA-4 therapy or combination therapy further increase this risk, highlighting the need for personalized treatment strategies.
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