Clinical, Endoscopic, and Histological Characteristics of Severe Immune Checkpoint Inhibitor-Induced Colitis
<b>Background:</b> Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy. They can cause immune-mediated colitis (IMC), a potentially severe adverse event. Current data on severe IMC (grade 3-4) are limited, particularly regarding clinical, endoscopic, and histological features. <b>Methods:</b> We conducted a multicenter, retrospective observational study promoted by GETECCU, including adults with solid tumors who developed grade 3-4 IMC requiring hospitalization and systemic therapy. Clinical symptoms, endoscopic findings (Mayo and UCEIS indices), and histological features were systematically collected and analyzed. <b>Results:</b> A total of 196 patients were included. Diarrhea was universal (median 8 bowel movements/day), with 76% reporting abdominal pain and 39% rectal bleeding. Endoscopy (n = 139) revealed vascular pattern loss (80%), mucosal lesions (69%), and Mayo scores ≥2 in 69%. Histopathology (n = 141) showed abnormalities in 85%, including cryptitis (50%), lymphocytic infiltration (48%), and crypt abscesses (37%). Notably, 72% of patients with normal endoscopy had histological inflammation. Endoscopic severity correlated with bleeding and impaired general condition but not with stool frequency or pain intensity. Histological and endoscopic severity were modestly associated. <b>Conclusions:</b> Severe IMC presents with heterogeneous clinical, endoscopic, and histological features, with limited correlation between these domains. Endoscopic findings were often ulcerative and inflammatory, yet histological abnormalities were frequently present even in endoscopically inactive disease. These findings highlight the importance of biopsy in all suspected IMC cases and underscore the need for validated multidimensional assessment tools for accurate diagnosis and management of severe IMC.
Authors
- Begoña Álvarez Herrero
- María Calvo Íñiguez (ORCID: https://orcid.org/0000-0002-9862-2427)
- José Miranda Bautista
- Pablo Miles Wolfe García
- Belén Herreros Martínez
- A Gutiérrez
- J X Segarra-Ortega
- Laura López Couceiro
- Fernando Martínez de Juan (ORCID: https://orcid.org/0000-0003-1554-7861)
- Raquel Vicente Lidón
- Pablo Ladrón Abia (ORCID: https://orcid.org/0000-0001-8057-4781)
- X Serra Ruiz (ORCID: https://orcid.org/0000-0003-2478-8923)
- Luis Menchén
- Alejandro Garrido Marín
- García María José
- Francisco Rodríguez‐Moranta (ORCID: https://orcid.org/0000-0003-4025-5510)
- Empar Sáinz
- Silvia Patrícia Ortega Moya
- Pere Garriga (ORCID: https://orcid.org/0000-0003-4234-8382)
- E Betoré Glaría
- Ingrid Ordàs
- Virginia Matallana Royo
- Santiago García López
- Inmaculada Alonso Abreu (ORCID: https://orcid.org/0009-0008-4497-9763)
- Carla Folguera
- Coral Rivas Rivas
- M Marques Cami
- R Ferreiro-Iglesias
- M.V. Lorenzo
- Cristina Polo Cuadro
- Mañosa Míriam
- Alexandra Ruiz Cerulla
- Irene García de la Filia Molina (ORCID: https://orcid.org/0000-0003-3304-896X)
- Óscar Moralejo Lozano (ORCID: https://orcid.org/0000-0002-4808-6363)
- Patricia Sanz Segura
- Manuel Barreiro-de Acosta
- Yamile Zabana
- Gerard Surís
- Raquel Mena Sánchez
- Elena Céspedes Martínez
- N. Marcos
- Santiago Frago Larramona
- Javier Santos Fernández
- Esther Rodríguez González
- Cristina Roig Ramos
- Lucía Madero Velázquez
- Eduard Brunet Mas
- Cristina Almingol Crespo
- Marta Gascón Ruiz
- Diego Casas Deza
- Coral Tejido Sandoval
- Francisco Mesonero Gismero
Institutions
- Hospital Universitario de Canarias (ES)
- Hospital de Sant Pau (ES)
- Bellvitge University Hospital (ES)
- Hospital Universitari Arnau de Vilanova (ES)
- Hospital General Universitario Gregorio Marañón (ES)
- Hospital Universitari i Politècnic La Fe (ES)
- Hospital Universitario Nuestra Señora de Candelaria (ES)
- Althaia (ES)
- Consorci Sanitari de Terrassa (ES)
- Complejo Hospitalario de Salamanca (ES)
- Biogipuzkoa Health Research Institute (ES)
- Hospital Royo Villanova (ES)
- Fundación Instituto Valenciano de Oncología (ES)
- Hospital Sierrallana (ES)
- Hospital Universitario Puerta de Hierro Majadahonda (ES)
- Hospital Universitario Araba (ES)
- Instituto de Investigación Marqués de Valdecilla (ES)
- Hospital Clínic de Barcelona (ES)
- Hospital Universitario de Burgos (ES)
- Hospital de Galdakao (ES)
- Hospital de Sabadell (ES)
- Vall d'Hebron Hospital Universitari (ES)
- Mútua Terrassa (ES)
- Hospital Del Mar (ES)
- Instituto de Investigación Sanitaria Aragón (ES)
- Hospital General Universitario de Alicante Doctor Balmis (ES)
- Hospital San Pedro (ES)
- Donostiako Unibertsitate Ospitalea (ES)
- Instituto de Investigación Sanitaria de Santiago (ES)
- Hospital Universitari Joan XXIII de Tarragona (ES)
- Hospital Universitari Germans Trias i Pujol (ES)
- Hospital Comarcal de Inca (ES)
- Hospital General San Jorge (ES)
- Hospital Marina Baixa (ES)
- Hospital Universitario Infanta Sofía (ES)
- Hospital Universitario Ramón y Cajal (ES)
- Complejo Hospitalario Universitario de Toledo (ES)
- Complejo Asistencial Universitario de Palencia (ES)
- Complejo Hospitalario de Ourense (ES)
- Hospital Universitario Infanta Cristina (ES)
Publication Details
- Journal
- Journal of Clinical Medicine
- Published
- 2026-01-02
- DOI
- https://doi.org/10.3390/jcm15010353
- Primary Topic
- Cancer Immunotherapy and Biomarkers
- Type
- article
- Field-Weighted Citation Impact
- 0.00