Objective  To analyze the characteristics of immune checkpoint inhibitor (ICI)-induced colitis and to evaluate the treatment outcomes in patients.

Methods  This single-center retrospective study collected confirmed cases of ICI-induced colitis from the Sixth Affiliated Hospital of Sun Yat-sen University between January 2021 and December 2024. Data on patients’ baseline characteristics, medication regimens, clinical manifestations, endoscopic and pathological features, and treatment outcomes were analyzed.

Results  A total of 20 ICI-related colitis cases were included. Patient ages ranged from 33 to 88 years, with 16 cases (80.0%) being male. The median time to onset of ICI-induced colitis was 77 days, with PD-1 inhibitors accounting for the highest proportion (17 cases, 85.0%). Patients predominantly presented with diarrhea, accompanied by abdominal pain and hematochezia. Endoscopic findings showed pancolonic involvement, with histopathology demonstrating inflammatory cell infiltration and crypt distortion. The treatment strategy was based on glucocorticoids or mesalazine, with favorable outcomes observed in refractory cases following the addition of biologic agents.

Conclusion  ICI-induced colitis presents distinct clinicopathological features. Hierarchical treatment strategy demonstrates favorable outcomes. Baseline characteristics and endoscopic findings of patients hold significant value for prognostic assessment.

1.Jayathilaka B, Mian F, Franchini F, et al. Cancer and treatment specific incidence rates of immune-related adverse events induced by immune checkpoint inhibitors: a systematic review[J]. Br J Cancer, 2025, 132(1): 51-57. DOI: 10.1038/s41416-024-02887-1.

2.王伟, 张敏, 陈白莉. 免疫抑制剂检查点相关肠炎的诊治进展 [J]. 中华炎性肠病杂志, 2021, 5(3): 237-241. [Wang W, Zhang M, Chen BL. Research progress of immune checkpoint inhibitor-induced enterocolitis[J]. Chinese Journal of Inflammatory Bowel Diseases, 2021, 5(3): 237-241.] DOI: 10.3760/cma.j.cn101480-20210409-00027.

3.孙菁, 邹多武. 免疫检查点抑制剂治疗相关胃肠道不良反应的临床诊疗管理[J]. 中华消化杂志, 2021, 41(3): 214-216. [Sun J, Zou DW. Clinical diagnosis and management of gastrointestinal side effects associated with immune checkpoint inhibitor therapy[J]. Chinese Journal of Digestion, 2021, 41(3): 214-216.] DOI: 10.3760/cma.j.cn311367-20200313-00139.

4.Thompson JA, Schneider BJ, Brahmer J, et al. NCCN guidelines® insights: management of immunotherapy-related toxicities, version 2.2024[J]. J Natl Compr Canc Netw, 2024, 22(9): 582-592. DOI: 10.6004/jnccn.2024.0057.

5.Nakane T, Mitsuyama K, Yamauchi R, et al. Characteristics of immune checkpoint inhibitor-induced colitis: a systematic review[J]. Kurume Med J, 2023, 68(2): 43-52. DOI: 10.2739/kurumemedj.MS682006.

6.卢璐, 冯煜, 阎良. 6例免疫检查点抑制剂相关性结肠炎的临床特征分析[J]. 实用药物与临床, 2024, 27(1): 45-49. [Lu L, Feng Y, Yan L. Clinical characteristies analysis of 6 cases of immune checkpoint inhibitor-related colitis[J]. Practical Pharmacy And Clinical Remedies, 2024, 27(1): 45-49.] DOI: 10.14053/j.cnki.ppcr.202401010.

7.谭蓓, 王汉萍, 李玥, 等. 免疫检查点抑制剂相关结肠炎八例临床特征分析[J]. 中华消化杂志, 2021, 41(5): 330-335. [Tan B, Wang HP, Li Y, et al. Clinical characteristics of eight cases of immune checkpoint inhibitor-related colitis[J]. Chinese Journal of Digestion, 2021, 41(5): 330-335.] DOI: 10.3760/cma.j.cn311367-20201014-00602.

8.中国临床肿瘤学会指南工作委员会, 编著. 免疫检查点抑制剂相关的毒性管理指南（2023版）[M]. 北京: 人民卫生出版社, 2023: 60-65.

9.王冬雪, 侯继秋, 张新茹, 等. 111例药源性急性肾损伤临床特点及影响因素[J]. 医药导报, 2019, 38(7): 961-965. [Wang DX, Hou JQ, Zhang XR, et al. Clinical characteristics and influencing factors of 111 cases of drug-induced acute kidney injury[J]. Herald of Medicine, 2019, 38(7): 961-965.] DOI: 10.3870/j.issn.1004-0781.2019.07.028.

10.Rocha M, Correia de Sousa J, Salgado M, et al. Management of gastrointestinal toxicity from immune checkpoint inhibitor[J]. GE Port J Gastroenterol, 2019, 26(4): 268-274. DOI: 10.1159/000494569.

11.Satsangi J, Silverberg MS, Vermeire S, et al. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications[J]. Gut, 2006, 55(6): 749-753. DOI: 10.1136/gut.2005.082909.

12.中华医学会肠外肠内营养学分会. 营养风险及营养风险筛查工具营养风险筛查2002临床应用专家共识（2018版）[J]. 中华临床营养杂志, 2018, 26(3): 131-135. [Chinese Society for Parenteral and Enteral Nutrition of the Chinese Medical Association. Expert consensus on nutritional risk and the clinical application of the nutritional risk screening 2002 (NRS-2002) tool (2018 edition)[J]. Chinese Journal of Clinical Nutrition, 2018, 26(3): 131-135.] DOI: 10.3760/cma.j.issn.1674-635X.2018.03.001.

13.Unger JM, Vaidya R, Albain KS, et al. Sex differences in risk of severe adverse events in patients receiving immunotherapy, targeted therapy, or chemotherapy in cancer clinical trials[J]. J Clin Oncol, 2022, 40(13): 1474-1486. DOI: 10.1200/JCO.21. 02377.

14.王劲松, 魏家燕, 彭敏. 2023年美国癌症统计报告和全球最新癌症统计数据解读及启示[J]. 实用肿瘤杂志, 2023, 38(6): 523-527. [Wang JS, Wei JY, Peng M. Interpretation and enlightenment of 2023 American cancer statistics report and the latest global cancer[J]. Journal of Practical Oncology, 2023, 38(6): 523-527.] DOI: 10.13267/j.cnki.syzlzz.2023.083.

15.Wang F, Yang S, Palmer N, et al. Real-world data analyses unveiled the immune-related adverse effects of immune checkpoint inhibitors across cancer types[J]. NPJ Precis Oncol, 2021, 5(1): 82. DOI: 10.1038/s41698-021-00223-x.

16.Luoma AM, Suo S, Williams HL, et al. Molecular pathways of colon inflammation induced by cancer immunotherapy[J]. Cell, 2020, 182(3): 655–671. e622. DOI: 10.1016/j.cell.2020.06.001.

17.Gu L, Khadaroo PA, Su H, et al. The safety and tolerability of combined immune checkpoint inhibitors (anti-PD-1/PD-L1 plus anti-CTLA-4): a systematic review and Meta-analysis[J]. BMC Cancer, 2019, 19(1): 559. DOI: 10.1186/s12885-019-5785-z.

18.Blum SM, Zlotoff DA, Smith NP, et al. Immune responses in checkpoint myocarditis across heart, blood and tumour[J]. Nature, 2024, 636(8041): 215-223. DOI: 10.1038/s41586-024-08105-5.

19.方建锋. 肠道菌群与代谢性疾病关系研究进展[J]. 国际医药卫生导报, 2023, 29(16): 2225-2229. [Fang JF. Relationship between intestinal floras and metabolic diseases[J]. International Medicine and Health Guidance News. 2023, 29(16) : 2225-2229.] DOI: 10.3760/cma.j.issn.1007-1245.2023.16.002.

20.黄蓉, 欧希龙. 肠道黏膜屏障功能损伤机制及其防治的研究进展[J]. 现代医学, 2015, (5): 659-662. [Huang R, Ou XL. Research progress on the mechanisms of intestinal mucosal barrier dysfunction and its prevention and treatment[J]. Modern Medical Journal, 2015, (5): 659-662.] DOI: 10.3969/i.issn.1671-7562. 2015.05.037.

21.Nielsen DL, Juhl CB, Chen IM, et al. Immune checkpoint inhibitor-induced diarrhea and colitis: incidence and management. A systematic review and Meta-analysis[J]. Cancer Treat Rev, 2022, 109: 102440. DOI: 10.1016/j.ctrv.2022.102440.

22.王羽宁. 不同肿瘤中抗PD-1/PD-L1免疫治疗相关不良反应的临床特征分析[D]. 长春: 吉林大学, 2024. DOI: 10.27162/d.cnki.gjlin.2024.005316.

23.Wang Y, Zhou S, Yang F, et al. Treatment-related adverse events of PD-1 and PD-L1 inhibitors in clinical trials: a systematic review and Meta-analysis[J]. JAMA Oncol, 2019, 5(7): 1008-1019. DOI: 10.1001/jamaoncol.2019.0393.

24.Ladjevardi CO, Skribek M, Koliadi A, et al. Differences in immune-related toxicity between PD-1 and PD-L1 inhibitors: a retrospective cohort study in patients with advanced cancer[J]. Cancer Immunol Immunother, 2024, 74(1): 14. DOI: 10.1007/s00262-024-03869-1.

25.Xu Q, Hu J, Wang Y, et al. The role of tumor types in immune-related adverse events[J]. Clin Transl Oncol, 2025, 27(8): 3247-3260. DOI: 10.1007/s12094-024-03798-6.

26.Yao J, Li M, Zhang H, et al. Differential risks of immune-related colitis among various immune checkpoint inhibitor regimens[J]. Int Immunopharmacol, 2020, 87: 106770. DOI: 10.1016/j.intimp.2020.106770.

27.Yang W, Men P, Xue H, et al. Risk of gastrointestinal adverse events in cancer patients treated with immune checkpoint Inhibitor plus chemotherapy: a systematic review and Meta-analysis[J]. Front Oncol, 2020, 10: 197. DOI: 10.3389/fonc.2020.00197.

28.于涛, 王鑫, 曹晓仓, 等. 肠镜检查在评估免疫检查点抑制剂相关结肠炎中的临床意义[J]. 中国肿瘤临床, 2024, (17): 909-914. [Yu T, Wang X, Cao XC, et al. Clinical significance of colonoscopy in the evaluation of immune checkpoint inhibitor-associated colitis[J]. Chinese Journal of Clinical Oncology. 2024, (17): 909-914.] DOI: 10.12354/i.issn.1000-8179.2024. 20240935.

29.时绘绘, 宇文利霞, 甄建龙, 等. 肺癌患者免疫检查点抑制剂相关胃肠道不良反应的影响因素分析及预测模型构建[J]. 临床误诊误治, 2024, 37(19): 43-48, 84. [Shi HH, Yuwen LX, Zhen JL et al. Analysis of influencing factors and construction of predictive model for gastrointestinal adverse reactions related to immune checkpoint inhibitors in patients with lung cancer[J]. Clinical Misdiagnosis & Mistherapy, 2024, 37(19): 43-48, 84.] DOI: 10.3969/i.issn.1002-3429.2024.19.009.

30.Zou F, Faleck D, Thomas A, et al. Efficacy and safety of vedolizumab and infliximab treatment for immune-mediated diarrhea and colitis in patients with cancer: a two-center observational study[J]. J Immunother Cancer, 2021, 9(11): e003277. DOI: 10.1136/jitc-2021-003277.

31.刘玲, 董文逍, 王邦茂, 等. 生物制剂治疗免疫检查点抑制剂相关性结肠炎的研究进展[J]. 中华炎性肠病杂志, 2023, 7(4): 355-359. [Liu L, Dong WX, Wang BM, et al. Research progress of biologics for the treatment of immune checkpoint inhibitor-induced colitis[J]. Chinese Journal of Inflammatory Bowel Diseases, 2023, 7(4): 355-359.] DOI: 10.3760/cma.j.cn101480-20221213-00204.

32.Alorfi NM, Alourfi MM. Biologic therapy for refractory immune checkpoint inhibitor colitis[J]. Biologics, 2022, 16: 119-127. DOI: 10.2147/BTT.S367675.