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.
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.
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.
摘要：
背景：关于免疫检查点抑制剂（ICI）诱导的结肠炎患者的临床结果的数据很少。我们旨在描述ICI诱导的结肠炎患者的12个月临床结局。
方法：这是一个回顾性研究，欧洲,多中心研究。纳入内镜/组织学证实的ICI诱导的结肠炎患者。12个月的临床缓解率，定义为0-1级腹泻不良事件的通用术语标准,并评估12个月缓解的相关性.
结果：96名患者[男性：女性比例1.5：1；中位年龄65岁，四分位距（IQR）55.5-71.5年]包括在内。肺癌(41,42.7%)和黑色素瘤(30,31.2%)是最常见的癌症。ICI相关的胃肠道症状出现在中位时间4个月(IQR2-7个月)。74例患者（77.1%）[35例（47.3%）溃疡性结肠炎（UC）样，11（14.9%）克罗恩病（CD）样，28（37.8%）类似IBD的未分类]，而19例患者存在显微镜下结肠炎(19.8%)。作为第一行，全身性类固醇是处方最多的药物(65,67.7%).12个月临床缓解率为47.7/100人年[95％置信区间（CI）33.5-67.8）。66例患者（79.5%）因结肠炎停止ICI治疗。CD样模式与缓解失败相关（风险比3.84，95％CI1.16-12.69）。具有显微结肠炎（P=0.049）和显微与UC/CD样结肠炎（P=0.014）的组织病理学征象与更好的结果相关。停止ICI与12个月的缓解无关（P=0.483）。4例患者（3.1%）死于ICI诱导的结肠炎。
结论：IBD样结肠炎患者可能需要早期和更积极的治疗。未来的研究应该集中在如何改善长期临床结果。
方法：这是一个回顾性研究，欧洲,多中心研究。纳入内镜/组织学证实的ICI诱导的结肠炎患者。12个月的临床缓解率，定义为0-1级腹泻不良事件的通用术语标准,并评估12个月缓解的相关性.
结果：96名患者[男性：女性比例1.5：1；中位年龄65岁，四分位距（IQR）55.5-71.5年]包括在内。肺癌(41,42.7%)和黑色素瘤(30,31.2%)是最常见的癌症。ICI相关的胃肠道症状出现在中位时间4个月(IQR2-7个月)。74例患者（77.1%）[35例（47.3%）溃疡性结肠炎（UC）样，11（14.9%）克罗恩病（CD）样，28（37.8%）类似IBD的未分类]，而19例患者存在显微镜下结肠炎(19.8%)。作为第一行，全身性类固醇是处方最多的药物(65,67.7%).12个月临床缓解率为47.7/100人年[95％置信区间（CI）33.5-67.8）。66例患者（79.5%）因结肠炎停止ICI治疗。CD样模式与缓解失败相关（风险比3.84，95％CI1.16-12.69）。具有显微结肠炎（P=0.049）和显微与UC/CD样结肠炎（P=0.014）的组织病理学征象与更好的结果相关。停止ICI与12个月的缓解无关（P=0.483）。4例患者（3.1%）死于ICI诱导的结肠炎。
结论：IBD样结肠炎患者可能需要早期和更积极的治疗。未来的研究应该集中在如何改善长期临床结果。
