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Case Report

From Innovation to Complication: A Case Report and Review on Immune-Related Colitis Induced by ICIs

1
Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
2
State Key Laboratory of Quality Research in Chinese Medicine, School of Pharmacy, Macau University of Science and Technology, Macau SAR 999078, China
3
Department of Pharmacy, Peking University Third Hospital Qinhuangdao Hospital, Qinhuangdao 066000, China
4
Department of Gastroenterology, Peking University Third Hospital, Beijing 100191, China
5
Shanghai Key Laboratory of Bioactive Small Molecules, Department of Pharmacology, School of Pharmacy, Fudan University, Shanghai 200437, China
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this work.
Pharmaceuticals 2025, 18(8), 1211; https://doi.org/10.3390/ph18081211
Submission received: 18 June 2025 / Revised: 1 August 2025 / Accepted: 13 August 2025 / Published: 15 August 2025
(This article belongs to the Special Issue Tumor Immunopharmacology)

Abstract

Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy by providing durable responses and a favorable safety profile, ushering in a new era of tumor immunotherapy. However, immune-related adverse events (irAEs) remain a significant clinical challenge. Among these, gastrointestinal irAEs, especially immune-related colitis (ir-colitis), can lead to serious complications if not promptly recognized and managed. Here, we present a case of grade 3 ir-colitis induced by the programmed cell death protein 1 (PD-1) inhibitor sintilimab in a 68-year-old woman with endometrial cancer. The patient developed severe acute diarrhea following ICI administration, which progressed despite initial antidiarrheal and antimicrobial treatments. A multidisciplinary team (MDT) involving gastroenterologists, oncologists, a pathologist, and a clinical pharmacist confirmed the diagnosis and implemented high-dose corticosteroid therapy, yielding significant clinical improvement. Importantly, this report highlights the mechanistic link between PD-1 blockade and ir-colitis pathogenesis, focusing on the dysregulation of the mucosal immune environment and its role in triggering colonic injury. In addition to the case description, we provide a comprehensive review of the literature and clinical guidelines, discussing risk factors, diagnostic approaches, therapeutic strategies, and long-term monitoring. By integrating insights from pharmacology, immunology, and clinical practice, this work emphasizes the importance of early detection, patient education, and MDT collaboration for optimizing therapeutic outcomes and advancing the understanding of ir-colitis in the context of ICI therapy.
Keywords: immune checkpoint inhibitors; diarrhea; colitis; sintilimab; immune-related adverse events immune checkpoint inhibitors; diarrhea; colitis; sintilimab; immune-related adverse events

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MDPI and ACS Style

Li, H.; Pan, Y.; Liu, W.; Zhang, H.; Tian, X.; Zhao, R.; Zhu, Y.Z. From Innovation to Complication: A Case Report and Review on Immune-Related Colitis Induced by ICIs. Pharmaceuticals 2025, 18, 1211. https://doi.org/10.3390/ph18081211

AMA Style

Li H, Pan Y, Liu W, Zhang H, Tian X, Zhao R, Zhu YZ. From Innovation to Complication: A Case Report and Review on Immune-Related Colitis Induced by ICIs. Pharmaceuticals. 2025; 18(8):1211. https://doi.org/10.3390/ph18081211

Chicago/Turabian Style

Li, Huibo, Yumiao Pan, Wenzheng Liu, Hejun Zhang, Xueli Tian, Rongsheng Zhao, and Yi Zhun Zhu. 2025. "From Innovation to Complication: A Case Report and Review on Immune-Related Colitis Induced by ICIs" Pharmaceuticals 18, no. 8: 1211. https://doi.org/10.3390/ph18081211

APA Style

Li, H., Pan, Y., Liu, W., Zhang, H., Tian, X., Zhao, R., & Zhu, Y. Z. (2025). From Innovation to Complication: A Case Report and Review on Immune-Related Colitis Induced by ICIs. Pharmaceuticals, 18(8), 1211. https://doi.org/10.3390/ph18081211

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