Incidence of and Risk Factors for Anti-PD-1/PD-L1- Associated Diarrhea and Colitis: A Retrospective Cohort Study of the Chinese Population.

Background and Objectives: The prevalence of and risk factors for immune checkpoint inhibitor-associated diarrhea and colitis (IMDC) in the Chinese population are unclear. This study aimed to estimate IMDC incidence and identify potential risk factors. Materials and Methods: We reviewed the electronic medical records from Beijing Friendship Hospital (2015-2022) to identify the patients treated with immune checkpoint inhibitors. The primary outcome was IMDC occurrence. The demographics, cancer type, baseline labs, and concurrent medications were analyzed. The univariable and multivariable analyses validated the associated factors. Results: Among 1186 patients (median follow-up: 217 days), the IMDC incidence was 4.6%, with colitis at 0.67%. Digestive system tumors increased the IMDC risk (OR 2.79, 95% CI 1.42-5.75, p = 0.004), while platinum agents decreased it (OR 0.41, 95% CI 0.21-0.78, p = 0.008). PPIs, antibiotics, NSAIDs, and glucocorticoids showed no significant association. Colitis was the third most common irAE, leading to ICI discontinuation (15.6%). Conclusions: IMDC prevalence is 4.6% in the Chinese population, the third most frequent irAE causing ICI discontinuation. Digestive tumors and platinum agents are risk and protective factors, respectively, while other medications show no significant impact.