• Carl Eriksson, Jan Marsal, Daniel Bergemalm, Lina Vigren, Jan Björk, Michael Eberhardson, Pontus Karling, Charlotte Söderman, SWIBREG Vedolizumab Study Group, Pär Myrelid, Yang Cao, Daniel Sjöberg, Mari Thörn, Per Karlén, Erik Hertervig, Hans Strid, Jonas F Ludvigsson, Sven Almer, and Jonas Halfvarson.
• a Department of Gastroenterology, Faculty of Medicine and Health , Örebro University , Örebro , Sweden.
• Scand. J. Gastroenterol. 2017 Jun 1; 52 (6-7): 722-729.

ObjectivesClinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness.Materials And MethodsPatients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn's disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC).ResultsTwo-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14-20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96-16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10-4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16-6.48).ConclusionVedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

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