I-CARE, a European prospective cohort study assessing safety and effectiveness of biologics in inflammatory bowel disease

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 was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious...

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Elmentve itt :
Bibliográfiai részletek
Szerzők: Peyrin-Biroulet Laurent
Rahier Jean-François
Kirchgesner Julien
Abitbol Vered
Sebastian Shaji
Armuzzi Alessandro
Karmiris Konstantinos
Gisbert Javier P.
Bossuyt Peter
Helwig Ulf
Burisch Johan
Yanai Henit
Glen A. Doherty
Molnár Tamás
Kollaborációs Szervezet: I-CARE Collaborator Group
Dokumentumtípus: Cikk
Megjelent: 2023
Sorozat:CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 21 No. 3
Tárgyszavak:
doi:10.1016/j.cgh.2022.09.018

mtmt:33127876
Online Access:http://publicatio.bibl.u-szeged.hu/25281
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520 3 |a 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 was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with for anti-tumor necrosis factor and other biologics monotherapy as well as in combination with immunomodulators.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.A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6,169 (60.4%) patients with Crohn's disease, 3,853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving AZA/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 % 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.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. 
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700 0 1 |a Kirchgesner Julien  |e aut 
700 0 1 |a Abitbol Vered  |e aut 
700 0 1 |a Sebastian Shaji  |e aut 
700 0 1 |a Armuzzi Alessandro  |e aut 
700 0 1 |a Karmiris Konstantinos  |e aut 
700 0 1 |a Gisbert Javier P.  |e aut 
700 0 1 |a Bossuyt Peter  |e aut 
700 0 1 |a Helwig Ulf  |e aut 
700 0 1 |a Burisch Johan  |e aut 
700 0 1 |a Yanai Henit  |e aut 
700 0 2 |a Glen A. Doherty  |e aut 
700 0 2 |a Molnár Tamás  |e aut 
700 0 2 |a Kollaborációs Szervezet: I-CARE Collaborator Group  |e aut 
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856 4 0 |u http://publicatio.bibl.u-szeged.hu/25281/7/33127876_megjelent.pdf  |z Dokumentum-elérés