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. 2025 Oct 13;14(20):7219.
doi: 10.3390/jcm14207219.

Immune Checkpoint-Induced Colitis: A Single-Center Retrospective Cohort Study

Bengt Van Holder  1   2 , Julie Vereecke  2   3 , Nathan Ureel  2 , Triana Lobatón  2   3 , Anne Hoorens  2   4 , Amber Lievens  2   4 , Marie Truyens  2   3 , Sylvie Rottey  1   2 , Karim Vermaelen  2   5 , Venita D'Cruz  3 , Jeroen Geldof  2   3 , Celine Jacobs  1 , Eline Naert  1   2 , Elien De Mulder  1 , Michael Saerens  1   2
Affiliations

Immune Checkpoint-Induced Colitis: A Single-Center Retrospective Cohort Study

Bengt Van Holder et al. J Clin Med. .

Abstract

Background: Immune checkpoint inhibitors (ICIs) have transformed cancer therapy but are often complicated by immune-related adverse events, particularly colitis. With increasing ICI use, understanding the clinical course and management of ICI-induced colitis is essential. Objectives: To characterize the clinical, endoscopic, and histological features of ICI-induced colitis and evaluate treatment outcomes, focusing on the use of corticosteroids and second-line biologicals (infliximab and vedolizumab) in a real-world setting. Methods: A retrospective cohort study was conducted at Ghent University Hospital, including 77 adult patients diagnosed with ICI-induced colitis in between 2012 and 2023. Clinical, biochemical, endoscopic, and histological data were analyzed, along with treatment response and safety outcomes. Results: Patients with ICI-induced colitis received anti-PD-1/PD-L1 (64.9%), anti-CTLA-4 (9.1%), or combination of both (26.0%). In patients with normal endoscopic findings, histological signs of colitis were observed in 88.0%. Combination ICI therapy was associated with higher Mayo scores (p = 0.029) and increased need for biologicals (p = 0.011) compared to anti-PD-1/PD-L1 monotherapy. Clinical response rates were 79.6% with corticosteroids and 100.0% with biologicals. Rechallenge with ICIs lead to a 17.4% relapse rate. No colitis-related deaths were observed. Conclusions: In this retrospective study, we demonstrate that random colon biopsies reveal microscopic ICI-induced colitis in most patients with absence of endoscopic disease. Combination ICI therapy predicts a corticosteroid-refractory course, supporting the need for early escalation to biologicals. ICI rechallenge appears feasible, as relapse rates were relatively low and colitis morbidity remained manageable. Prospective studies are needed to refine therapeutic strategies and improve patient outcomes.

Keywords: colitis; immune-related adverse events; immunotherapy; infliximab; vedolizumab.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
PRISMA flow chart: patients included with ICI-induced colitis.
Figure 2
Figure 2
Distribution of the Mayo score for the different ICI regimens.
Figure 3
Figure 3
Distribution of the Mayo score at diagnosis of ICI-induced colitis and the histopathologic differentiation in patients with a Mayo score of zero. Mayo 0 in lightest blue; Mayo 1 in light blue, Mayo 2 in dark blue, Mayo 3 in darkest blue.
Figure 4
Figure 4
Clinical, biochemical, and endoscopic response/remission for patients treated with corticosteroids and/or biologicals.
Figure 5
Figure 5
Distribution of the need for biologicals for the different ICI regimens.
Figure 6
Figure 6
Progression-free survival for patients treated with systemic corticosteroids and biologicals compared to patients only treated with systemic corticosteroids. Cox regression analysis: hazard ratio for oncological disease progression = 0.31 (95% confidence interval = 0.11–0.86); p = 0.025. Not all patients could be included for survival analysis due to missing data.
Figure 7
Figure 7
Overall survival for patients treated with systemic corticosteroids and biologicals compared to patients only treated with systemic corticosteroids. Cox regression analysis: hazard ratio for overall survival = 0.48 (95% confidence interval = 0.20–1.15); p = 0.100. Not all patients could be included for survival analysis due to missing data.
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