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

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

Peyrin-Biroulet, Laurent (författare): University of Lorraine, Nancy, France; Nancy University Hospital, Nancy, France

Rahier, Jean-François (författare): Université catholique de Louvain, Yvoir, Belgium

Kirchgesner, Julien (författare): Sorbonne Université, Paris, France

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Abitbol, Vered (författare): Hopital Cochin, Paris, France; Université Paris Cité, Paris, France

Sebastian, Shaji (författare): Hull University Teaching Hospitals, Hull York, UK; Medical School/ University of Hull, Hull, UK

Armuzzi, Alessandro (författare): Research Hospital, Rozzano, Italy; Humanitas University, Milan, Italy

Karmiris, Konstantinos (författare): Venizeleio General Hospital, Heraklion, Greece

Gisbert, Javier P. (författare): Hospital Universitario de La Princesa, Madrid, Spain; Universidad Autónoma de Madrid (UAM), Madrid, Spain

Bossuyt, Peter (författare): Imelda General Hospital, Bonheiden, Belgium

Helwig, Ulf (författare): University of Kiel, Kiel, Germany

Burisch, Johan (författare): Copenhagen University Hospital, Copenhagen, Denmark

Yanai, Henit (författare): Rabin Medical Center, Petah-Tikva, Israel; Tel Aviv University, Tel Aviv, Israel

Doherty, Glen A. (författare): St. Vincent's University Hospital, Dublin, Ireland; University College Dublin, Ireland,INITIative IBD research network

Magro, Fernando (författare): Centro Hospitalar Universitário de São João, Porto, Portugal; Universidade do Porto, Porto, Portugal

Molnar, Tamás (författare): University of Szeged, Szeged, Hungary

Löwenberg, Mark (författare): Amsterdam University Medical Center, Amsterdam, The Netherlands

Halfvarson, Jonas, 1970- (författare): Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology

Zagorowicz, Edyta (författare): The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

Rousseau, Hélène (författare): Nancy University Hospital, Vandoeuvre-lès-Nancy, France

Baumann, Cédric (författare): Nancy University Hospital, Vandoeuvre-lès-Nancy, France

Baert, Filip (författare): AZ Delta Hospital, Roeselare, Belgium

Beaugerie, Laurent (författare): Sorbonne Université, Paris, France

I-CARE Collaborator Group, - (bidragsgivare)

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Elsevier, 2023
2023
Engelska.
Ingår i: Clinical Gastroenterology and Hepatology. - : Elsevier. - 1542-3565 .- 1542-7714. ; 21:3, s. 771-788.e10

Relaterad länk:: https://urn.kb.se/re...; visa fler...; https://doi.org/10.1...; http://kipublication...; visa färre...

Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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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 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.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 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.CONCLUSION: 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.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)

Nyckelord

I-CARE
biologics
cancer
efficacy
inflammatory bowel disease
lymphoma
safety

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MEDICIN OCH HÄLSOVETENSKAP: MEDICIN OCH HÄLS ...; och Klinisk medicin; och Cancer och onkol ...

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