Abstract
Abstract Background Patients with intestinal inflammatory diseases such as ulcerative colitis (UC), Crohn’s disease (CD) and microscopic colitis (MC) are excluded from clinical trials with immune checkpoint inhibitors (ICI) due to assumed increased risk of activation of the underlying immune mediated disease. Therefore, we aimed to evaluate the risk of developing disease activity or checkpoint inhibitor immune-mediated enterocolitis (IMEC) in patients with UC, CD or MC treated with ICI in a real-world cohort. Methods We performed a nation-wide Danish retrospective cohort study on patients with UC, CD and MC with cancer treated with checkpoint inhibitors from 2010 to 2024. Results Eighty-five patients were included in the study and IMEC was observed in 39 (46%) cases. IMEC was not severe in fifteen cases, and it was possible to continue ICI treatment in 61 patients (72%). When compared to a control cohort without intestinal disease (n=138), patients with UC, CD, and MC had a higher risk of IMEC if treated with anti-PD-1 or anti-PD-L1, hazard ratio (HR) 4.93, p<0.001. Not enough patients were treated with CTLA-4 alone or in combination with anti-PD-1/PD-L1 treatment to calculate these groups and therefore we can only describe the risk in patients treated with anti-PD-1/PD-L1. Multivariate logistic analysis showed that patients with CD had a lower odds ratio (OR) of IMEC compared to patients with UC and MC (OR 0.07, p=0.02). Conclusion Patients with CD appear to have a lower risk of IMEC compared to patients with UC and MC. Despite the high risk of developing IMEC in patients with UC, CD, and MC, 72% of the patients were able to continue first-line treatment with ICI after managing IMEC.
Published Version
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