TY - JOUR
T1 - I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease
AU - I-CARE Collaborator Group
AU - Peyrin-Biroulet, Laurent
AU - Rahier, Jean-François
AU - Kirchgesner, Julien
AU - Abitbol, Vered
AU - Shaji, Sebastian
AU - Armuzzi, Alessandro
AU - Karmiris, Konstantinos
AU - Gisbert, Javier P.
AU - Bossuyt, Peter
AU - Helwig, Ulf
AU - Burisch, Johan
AU - Yanai, Henit
AU - Doherty, Glen A.
AU - Magro, Fernando
AU - Molnar, Tamás
AU - Löwenberg, Mark
AU - Halfvarson, Jonas
AU - Zagorowicz, Edyta
AU - Rousseau, H. lène
AU - Baumann, C. dric
AU - Baert, Filip
AU - Beaugerie, Laurent
AU - Gornet, Jean-Marc
AU - Reimund, Jean-Marie
AU - Hebuterne, Xavier
AU - Amiot, Aurélien
AU - Armelao, Franco
AU - Blanc, Pierre
AU - Papi, Claudio
AU - de Chambrun, Guillaume Pineton
AU - Roblin, Xavier
AU - Chu, null
AU - Shariq, Sohail
AU - Viazis, Nikolaos
AU - Limdi, Jimmy
AU - Eder H, Piotr
AU - Michalopoulos, Georgios
AU - Bell, Andrew
AU - Biancone, Livia
AU - Dewitte, Marie
AU - Mazhar, Zia
AU - Franchimont, Denis
AU - Nancey, Stephane
AU - Macaigne, Gilles
AU - Principi, Maria Beatrice
AU - Fumery, Mathurin
AU - Jansen, Jeroen
AU - D'Haens, Geert
AU - Ponsioen, Cyriel
AU - Holsbergen, Maartje
AU - Parkes, Gareth
AU - Valats, Jean-Christophe
PY - 2022
Y1 - 2022
N2 - 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).
AB - 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).
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85147220109&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/36152897
U2 - https://doi.org/10.1016/j.cgh.2022.09.018
DO - https://doi.org/10.1016/j.cgh.2022.09.018
M3 - Article
C2 - 36152897
SN - 1542-3565
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
ER -