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Multicenter Study
. 2024 Jul;9(7):103632.
doi: 10.1016/j.esmoop.2024.103632. Epub 2024 Jul 5.

A 1-year follow-up study on checkpoint inhibitor-induced colitis: results from a European consortium

M V Lenti  1 , D G Ribaldone  2 , F Borrelli de Andreis  3 , M Vernero  2 , B Barberio  4 , M De Ruvo  4 , E V Savarino  4 , T Kav  5 , A Blesl  6 , M Franzoi  7 , H P Gröchenig  7 , D Pugliese  8 , G Ianiro  9 , S Porcari  9 , G Cammarota  9 , A Gasbarrini  9 , R Spagnuolo  10 , P Ellul  11 , K Foteinogiannopoulou  12 , I Koutroubakis  12 , K Argyriou  13 , M Cappello  14 , A Jauregui-Amezaga  15 , M G Demarzo  16 , N Silvestris  17 , A Armuzzi  18 , F Sottotetti  19 , L Bertani  20 , S Festa  21 , P Eder  22 , P Pedrazzoli  23 , A Lasagna  24 , A Vanoli  25 , G Gambini  26 , G Santacroce  1 , C M Rossi  1 , M Delliponti  27 , C Klersy  26 , G R Corazza  1 , A Di Sabatino  28 ; European Consortium for the study of immune checkpoint inhibitor-induced colitis
Collaborators, Affiliations
Multicenter Study

A 1-year follow-up study on checkpoint inhibitor-induced colitis: results from a European consortium

M V Lenti et al. ESMO Open. 2024 Jul.

Abstract

Background: Data regarding the clinical outcome of patients with immune checkpoint inhibitor (ICI)-induced colitis are scant. We aimed to describe the 12-month clinical outcome of patients with ICI-induced colitis.

Materials and methods: This was a retrospective, European, multicentre study. Endoscopy/histology-proven ICI-induced colitis patients were enrolled. The 12-month clinical remission rate, defined as a Common Terminology Criteria for Adverse Events diarrhoea grade of 0-1, and the correlates of 12-month remission were assessed.

Results: Ninety-six patients [male:female ratio 1.5:1; median age 65 years, interquartile range (IQR) 55.5-71.5 years] were included. Lung cancer (41, 42.7%) and melanoma (30, 31.2%) were the most common cancers. ICI-related gastrointestinal symptoms occurred at a median time of 4 months (IQR 2-7 months). An inflammatory bowel disease (IBD)-like pattern was present in 74 patients (77.1%) [35 (47.3%) ulcerative colitis (UC)-like, 11 (14.9%) Crohn's disease (CD)-like, 28 (37.8%) IBD-like unclassified], while microscopic colitis was present in 19 patients (19.8%). As a first line, systemic steroids were the most prescribed drugs (65, 67.7%). The 12-month clinical remission rate was 47.7 per 100 person-years [95% confidence interval (CI) 33.5-67.8). ICI was discontinued due to colitis in 66 patients (79.5%). A CD-like pattern was associated with remission failure (hazard ratio 3.84, 95% CI 1.16-12.69). Having histopathological signs of microscopic colitis (P = 0.049) and microscopic versus UC-/CD-like colitis (P = 0.014) were associated with a better outcome. Discontinuing the ICI was not related to the 12-month remission (P = 0.483). Four patients (3.1%) died from ICI-induced colitis.

Conclusions: Patients with IBD-like colitis may need an early and more aggressive treatment. Future studies should focus on how to improve long-term clinical outcomes.

Keywords: colitis; immunotherapy; infliximab; nivolumab; pembrolizumab.

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Figures

Figure 1
Figure 1
Kaplan–Meier clinical remission-free survival estimate (at 12 months).
Figure 2
Figure 2
Kaplan-Meier remission-free curves according to different variables of interest. (A) Kaplan–Meier remission-free estimate by Charlson Comorbidity Index (≤9 versus >9), by tumour stage (1-2 versus 3-4), and by discontinuation of immune checkpoint inhibitor (yes versus no). (B) Kaplan–Meier remission-free estimate by IBD-like patterns (UC-like versus CD-like versus IBD-like unclassified), by histopathological microscopic colitis pattern (lymphocytic versus collagenous versus non-microscopic colitis features), and by UC-/CD-like pattern versus ‘pure’ microscopic colitis. CD, Crohn’s disease; IBD, inflammatory bowel disease; UC, ulcerative colitis.
See this image and copyright information in PMC

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