Portal de investigação
I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Peyrin-Biroulet, L
- Rahier, JF
- Kirchgesner, J
- Abitbol, V
- Shaji, S
- Armuzzi, A
- Karmiris, K
- Gisbert, JP
- Bossuyt, P
- Helwig, U
- Burisch, J
- Yanai, H
- Doherty, GA
- Molnar, T
- Löwenberg, M
- Halfvarson, J
- Zagorowicz, E
- Rousseau, H
- Baumann, C
- Baert, F
- Beaugerie, L
- I-Care Collaborator Grp
Unidades de investigação
Abstract
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 unclas-sified 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 azathio-prine/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 vedolizu-mab, 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).
Dados da publicação
- ISSN/ISSNe:
- 1542-7714, 1542-3565
- Tipo:
- Article
- Páginas:
- 771-771
- Link para outro recurso:
- www.scopus.com
Clinical Gastroenterology and Hepatology W.B. Saunders Ltd
Citações Recebidas na Web of Science: 11
Citações Recebidas na Scopus: 17
Documentos
- Não há documentos
Filiações
Keywords
- Inflammatory Bowel Disease; Biologics; Safety; Efficacy; I-CARE; Cancer; Lymphoma
Financiamento
Proyectos asociados
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Estudo Observacional Académico (IronIBD) . 2021
Looking 4WARD: The role of dipeptidyl peptidase 4 (DPP-4) in inflammatory bowel disease (IBD) as a novel biomarker for predicting disease activity and monitoring response to therapy in IBD patients.
Investigador Principal: Fernando José Magro Dias
Estudo Observacional Académico (4WARD) . 2021
Isolated Ulceration of Crohn’s Anastomosis
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Estudo Clínico Académico . 2021
Histologic Features of Colon Biopsies (Geboes Score) Associated With Progression of Ulcerative Colitis for the First 36 Months After Biopsy
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2022
Therapeutic Drug Monitoring: An Emergent Approach in Inflammatory Bowel Disease
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2021
Contributo da endoscopia, biomarcadores e imagiologia na evolução clinica dos doentes com doença inflamatória intestinal
Investigador Principal: Fernando José Magro Dias
Estudo Clínico Académico . 2019
Citar a publicação
Peyrin L,Rahier JF,Kirchgesner J,Abitbol V,Shaji S,Armuzzi A,Karmiris K,Gisbert JP,Bossuyt P,Helwig U,Burisch J,Yanai H,Doherty GA,Magro F,Molnar T,Löwenberg M,Halfvarson J,Zagorowicz E,Rousseau H,Baumann C,Baert F,Beaugerie L,I GRP. I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease. Clin. Gastroenterol. Hepatol. 2023. 21. (3):p. 771-771. IF:12,600. (1).
