I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease

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. (eudra CT, Number: 2014-004728-23; clinical trials.gov, number: NCT02377258).