Reports of Adverse Reactions of Immune Checkpoint Inhibitor-Related Colitis

doi:10.19803/j.1672-8629.20260039

Abstract

Abstract: Objective To analyze the clinical characteristics of enteritis associated with immune checkpoint inhibitors (ICIs), and to provide a reference for rational clinical medications and management of such immune-related adverse reactions. Methods The clinical data of patients with ICIs-related enteritis admitted to our hospital between January 2020 and August 2025 was collected before the baseline demographics, medications, clinical features of enteritis, treatment regimens and clinical outcomes of these patients were statistically analyzed. Results A total of 29 patients were enrolled in this study, 24 of whom were male (82.76%) with a median age of 65. The overall incidence of ICIs-related enteritis was 0.92% (29/3 153). The median onset time of enteritis was 16 days after the first administration of ICIs. The dominating primary tumors were lung cancer in 9 cases (31.03%), gastric cancer in 6 cases (20.69%), and esophageal cancer in 5 cases (17.24%). Programmed cell death protein 1 (PD-1) inhibitors were the major ICIs used in patients with enteritis (28 cases, 96.55%), among which sintilimab was responsible for the largest number of cases (10 cases). Twenty-one of these patients (72.41%) were treated with ICIs combined with chemotherapy. There were 26 cases (89.66%) of grade 1-2 adverse reactions and 3 cases (10.34%) of grade 3-4 adverse reactions. The main treatments included symptomatic and supportive care (22 cases, 75.86%) and glucocorticoid therapy (6 cases, 20.69%), and 28 patients (96.55%) improved. Conclusion ICIs-related enteritis is more prevalent in elderly male patients with malignant tumors. The incidence of enteritis is relatively low in patients receiving PD-1 inhibitor monotherapy, but ICIs combined with chemotherapy can elevate the risk. Patients with ICIs-related enteritis have a favorable prognosis following quick interventions, and clinicians should monitor gastrointestinal symptoms within 3 months of ICIs administration.

Key words: Immune Checkpoint Inhibitors, PD-1, Sintilimab, Enteritis, Adverse Drug Reactions, Cancer

CLC Number:

WANG Yuting, LYU Xinge, PAN Chen, WU Yi, CUI Xiangli. Reports of Adverse Reactions of Immune Checkpoint Inhibitor-Related Colitis[J]. Chinese Journal of Pharmacovigilance, 2026, 23(6): 681-685.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20260039

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References

[1] WANG YT, ZHU FY, LYU XG, et al.Cases of Colitis Caused by Immune Checkpoint Inhibitors[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2026, 23(3): 318-322.
[2] LUOMA AM, SUO S, WILLIAMS HL, et al.Molecular Pathways of Colon Inflammation Induced by Cancer Immunotherapy[J]. Cell, 2020, 182(3): 655-671.
[3] ZHAO JR, CHEN J.Reflection on Re-Challenge of Immunotherapy after Diarrhea/Colitis Induced by Immune Checkpoint Inhibitors[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2025, 28(4): 304-309.
[4] MENG XN, SUN X, LIU HM.Research Progress of Immune Checkpoint Inhibitor-Related Colitis[J]. The Journal of Practical Medicine(实用医学杂志), 2024, 40(9): 1314-1319.
[5] RENGA G, NUNZI E, PARIANO M, et al.Optimizing Therapeutic Outcomes of Immune Checkpoint Blockade by a Microbial Tryptophan Metabolite[J]. J Immunother Cancer, 2022, 10(3): e003725.
[6] WANG X, YUAN P, YUE J, et al.Clinical Observation of Adverse Reactions of Immune Checkpoint Inhibitors in 20 Patients with Advanced Tumors and Literature Review[J]. Cancer Research on Prevention and Treatment(肿瘤防治研究), 2020, 47(6): 427-431.
[7] LI H, PAN Y, LIU W, et al.From Innovation to Complication: a Case Report and Review on Immune-Related Colitis Induced by ICIs[J]. Pharmaceuticals, 2025, 18(8): 1211.
[8] WANG LL.Meta-Analysis of Efficacy and Safety of PD-1 Inhibitors in the Treatment of Advanced Tumors[D]. Tianjin: Tianjin Medical University, 2020.
[9] LU L, FENG Y, YAN L.Analysis of Clinical Characteristics of 6 Cases of Immune Checkpoint Inhibitor-Related Colitis[J]. Practical Pharmacy and Clinical Remedies(实用药物与临床), 2024, 27(1): 45-49.
[10] ZHANG X, MA XC, ZHONG H, et al.Literature Review and Analysis of Immune-Related Colitis Induced by Nivolumab[J]. Chinese Journal of Drug Application and Monitoring(中国药物应用与监测), 2023, 20(1): 45-49.
[11] WANG XJ, LI Z, XU Y, et al.Case Report and Literature Review of Adverse Reactions of Tislelizumab[J]. Herald of Medicine(医药导报), 2023, 42(12): 1873-1878.
[12] Guideline Working Committee of Chinese Society of Clinical Oncology. Chinese Society of Clinical Oncology(CSCO) Guideline for the Management of Toxicities Related to Immune Checkpoint Inhibitors(中国临床肿瘤学会(CSCO)免疫检查点抑制剂相关的毒性管理指南)[M]. Beijing: People’s Medical Publishing House, 2019: 74.
[13] ZHAO J, SU CX.Interpretation of CSCO Guideline for the Management of Toxicities Related to Immune Checkpoint Inhibitors: Comparison with NCCN Guideline for Management of Immunotherapy-Related Toxicities[J]. Journal of Practical Oncology(实用肿瘤杂志), 2020, 35(1): 11-15.
[14] HAANEN J, OBEID M, SPAIN L, et al.Management of Toxicities from Immunotherapy: ESMO Clinical Practice Guideline for Diagnosis, Treatment and Follow-Up[J]. Ann Oncol, 2022, 33(12): 1217-1238.

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