Background and Aims

There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators.

Methods

I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn’s disease, ulcerative colitis, or IBD unclassified established at least 3 months prior to enrollment.

Results

A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn’s disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathioprine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizumab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia.

Conclusions

I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

中文翻译：

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I-CARE，一项评估生物制剂治疗炎症性肠病的安全性和有效性的欧洲前瞻性队列研究

背景和目标

有必要评估炎症性肠病 (IBD) 患者当前疗法的效益风险比，以提供最佳质量的护理。I-CARE（欧洲的 IBD 癌症和严重感染）的主要目标是评估 IBD 的前瞻性安全问题，特别关注接受抗肿瘤坏死因子和其他生物制剂治疗的患者患癌症/淋巴瘤和严重感染的风险单药治疗以及与免疫调节剂联合使用。

方法

I-CARE 被设计为一项欧洲前瞻性纵向观察性多中心队列研究，包括在入组前至少 3 个月诊断为克罗恩病、溃疡性结肠炎或 IBD 未分类的患者。

结果

2016 年 3 月至 2019 年 4 月期间共有 10,206 名患者入组，其中克罗恩病患者 6169 名（60.4%），溃疡性结肠炎患者 3853 名（37.8%），IBD 未分类诊断患者 184 名（1.8%）。32% 的患者在研究开始时接受了硫唑嘌呤/硫嘌呤、4.6% 的 6-巯基嘌呤和 3.2% 的甲氨蝶呤。纳入时，47.3% 的患者接受了抗肿瘤坏死因子药物治疗，8.8% 的患者接受了维多珠单抗治疗，3.4% 的患者接受了优特克单抗治疗。大约四分之一的患者 (26.8%) 之前接受过 IBD 相关手术。66% 的患者之前接受过全身性类固醇治疗。3% 的患者在入选前有癌症病史，1.1% 有结肠、食管或子宫颈高度不典型增生病史。

结论

I-CARE 是一项正在进行的研究者发起的观察性欧洲前瞻性队列研究，它将提供有关 IBD 患者生物疗法的长期益处和风险的独特信息。（EudraCT，编号：2014-004728-23；ClinicalTrials.gov，编号：NCT02377258）。