[en] BACKGROUND AND AIMS: We explored the potential for differential efficacy of vedolizumab between early and late ulcerative colitis [UC] with evaluation of clinical, endoscopic, and histological endpoints. METHODS: This was a multicentre, multinational, open-label study in patients with moderately-to-severely active UC, defining early UC by a disease duration <4 years and bio-naïve and late UC by a disease duration > 4 years and additional exposure to tumour necrosis factor antagonists. Patients received standard treatment with intravenous vedolizumab for 52 weeks [300 mg Weeks 0, 2, 6, every 8 weeks thereafter without escalation]. The primary endpoint was corticosteroid-free clinical remission with endoscopic improvement [total Mayo score ≤2 with no subscore >1] at both Weeks 26 and 52. RESULTS: A total of 121 patients were included: in the "early" group, 25/59 [42.4%] achieved the primary endpoint versus 19/62 [30.6%] in the "late" group [p = 0.18]. There were no significant differences between the two groups in endoscopic improvement [Week 26: "early" 32/59 [54.2%] versus "late" 29/62 [46.8%]; p = 0.412; Week 52: 27/59 [45.8%] versus 25/62 [40.3%]; p = 0.546] or in histological remission [Robarts Histopathology Index <3 without neutrophils in the epithelium and lamina propria] [Week 26: 24/59 [40.7%] versus 21/62 [33.9%]; p = 0.439; Week 52: 22/59 [37.3%] versus 22/62 [35.5%]; p = 0.837]. CONCLUSIONS: No significant differences in clinical, endoscopic, and histological outcomes were observed between "early" and "late" disease.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Vermeire, Séverine ; Department of Gastroenterology and Hepatology, Department of Chronic Diseases and Metabolism, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Hanzel, Jurij ; Department of Gastroenterology, UMC Ljubljana, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
Löwenberg, Mark; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Ferrante, Marc ; Department of Gastroenterology and Hepatology, Department of Chronic Diseases and Metabolism, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Bossuyt, Peter ; Imelda Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium.
Hoentjen, Frank; Department of Gastroenterology, Radboud University Medical Centre, Nijmegen, The Netherlands. ; Division of Gastroenterology, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
Franchimont, Denis; Department of Gastroenterology, Erasme Hospital, Brussels, Belgium.
Palatka, Károly; Division of Gastroenterology, Department of Internal Medicine, University of Debrecen, Debrecen, Hungary.
Peeters, Harald; Department of Gastroenterology, AZ Sint Lucas, Gent, Belgium.
Mookhoek, Aart; Institute of Tissue Medicine and Pathology, Bern University, Bern, Switzerland.
de Hertogh, Gert; Department of Pathology, University Hospitals Leuven, Leuven, Belgium.
Molnár, Tamás ; Division of Gastroenterology, Department of Medicine, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
van Moerkercke, Wouter; Department of Gastroenterology and Hepatology, Department of Chronic Diseases and Metabolism, University Hospitals Leuven, KU Leuven, Leuven, Belgium. ; Department of Gastroenterology, AZ Groeninge, Kortrijk, Belgium.
Lobatón, Triana ; Department of Gastroenterology and Hepatology, University Hospital Gent, Gent, Belgium. ; Department of Internal Medicine and Pediatrics, Gent University, Gent, Belgium.
Clasquin, Esmé; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Hulshoff, Melanie S; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Baert, Filip; Department of Gastroenterology, AZ Delta, Roeselare, Belgium.
D'Haens, Geert; Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands.
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