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

M. Lenti,D. Ribaldone,F. B. D. Andreis,M. Vernero,B. Barberio,M. D. Ruvo,E. Savarino,T. Kav,A. Blesl,M. Franzoi,H. P. Gröchenig,D. Pugliese,G. Ianiro,S. Porcari,G. Cammarota,A. Gasbarrini,R. Spagnuolo,P. Ellul,K. Foteinogiannopoulou,I. Koutroubakis,K. Argyriou,M. Cappello,A. Jauregui-Amezaga,M. Demarzo,N. Silvestris,A. Armuzzi,F. Sottotetti,L. Bertani,S. Festa,P. Eder,P. Pedrazzoli,A. Lasagna,A. Vanoli,G. Gambini,G. Santacroce,C. Rossi,M. Delliponti,C. Klersy,G. Corazza,A. D. Sabatino,Prof. Antonio Di,Sabatino,C. Mengoli,N. Aronico,F. Lepore,G. Broglio,S. Merli,G. Natalello,E. Alimenti,D. Scalvini,S. Muscarella,F. Agustoni,A. Pagani,S. Chiellino,S. Corallo,V. Musella,R. Cannizzaro,M. Vecchi,F. Caprioli,R. Gabbiadini,A. D. Buono,A. Premoli,L. Locati,A. Buda,A. Contaldo,A. Schiepatti,F. Biagi,D. Morano,M. Cuce,A. Kotsakis,G. Lisi

Published 2024 in ESMO Open

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.

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