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

Research output: Contribution to journalResearch articleContributedpeer-review


  • Université de Lorraine
  • Centre Hospitalier Universitaire UCL Namur
  • Assistance publique – Hôpitaux de Paris
  • Hopital Cochin
  • University of Hull
  • Humanitas University
  • Venizeleio General Hospital
  • Hospital Universitario de la Princesa
  • Imelda GI Clinical Research Center
  • Kiel University
  • Copenhagen University Hospital - Amager and Hvidovre
  • Tel Aviv University
  • University College Dublin
  • Centro Hospitalar Universitário de São João
  • University of Szeged
  • Amsterdam University Medical Centers (UMC)
  • Örebro University
  • Maria Sklodowska-Curie Institute of Oncology
  • CHU de Nancy
  • AZ Delta Hospital


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).


Original languageEnglish
JournalClinical Gastroenterology and Hepatology
Publication statusE-pub ahead of print - 22 Sept 2022

External IDs

Mendeley 7d0f1000-9866-3108-8a52-a6936a97b60f
Scopus 85147220109


Research priority areas of TU Dresden

Sustainable Development Goals

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