Disease Outcomes in Immune-Mediated Colitis: A Study Describing Initial Endoscopic and Histologic Presentations and Treatment Options

Abstract

Background: Immune-mediated colitis (IMC) is a toxicity associated with immune checkpoint inhibitors (ICIs) that is becoming increasingly common. Studies exploring the clinical course and outcomes of IMC have been limited to relatively small sample sizes (<200 patients). We therefore aimed to provide a comprehensive account of the clinical, endoscopic, and histologic features of IMC as well as the efficacy of IMC treatment in a representative sample.

Methods: This was a single-center retrospective study of all patients who received ICIs at our institution between January 2010 and February 2024 and subsequently developed IMC. Detailed information was collected from the electronic health record regarding patient demographics and IMC stool biomarkers, endoscopic and histologic reports, clinical symptoms and treatment, and outcomes such as clinical symptom remission, hospitalization, and mortality.

Results: A total of 1,151 patients were included. Patients commonly presented with diarrhea (98.3%) or abdominal pain (38.6%). Selective immunosuppressive therapy was needed in approximately 46% of patients, and 85% achieved symptom remission. Among patients with macroscopic inflammation on endoscopy, 250 (57.6%) had nonulcerative findings, whereas 139 (32.0%) had ulceration. Among patients with histologic inflammation, approximately 60% had acute inflammation, 28% had chronic inflammation, and 12% had microscopic inflammation. Infliximab was associated with a shorter time to clinical response and required fewer doses than vedolizumab, with comparable efficacy between the 2 treatments.

Conclusions: Our study represents the largest to date exploring the various manifestations of IMC, along with associated treatment approaches and outcomes. We found that its features overlap with those of different inflammatory colitides. Both infliximab and vedolizumab were equally effective in achieving symptom remission; however, infliximab was associated with a shorter time to response. As the number of patients affected by IMC continues to grow, larger-scale studies will be essential to validate and expand upon these findings.