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P622 In a Dutch real-life inflammatory bowel disease score cohort with 90% prior anti-tumour necrosis factor failure, vedolizumab showed a 25% remission rate: a retrospective multicentre study

R. Y. Gabriëls*1, A. P. J. de Graaf2, M. A. C. Meijssen2, J. M. Götz3, P. B. Mensink3, M. G. V. M. Russel3, H. M. Dullemen1, R. W. F. ter Steege1, R. K. Weersma1, G. Dijkstra1

1University of Groningen, University Medical Centre Groningen, Department of Gastroenterology and Hepatology, Groningen, Netherlands, 2Isala Hospital Sophia, Department of Gastroenterology and Hepatology, Zwolle, Netherlands, 3Medical Spectrum Twente, Department of Gastroenterology and Hepatology, Enschede, Netherlands

Background

Vedolizumab is a humanised monoclonal antibody against α4β7-integrin capable of blocking the migration of several immune cells across endothelium expressing MAdCAM-1. This new class of biological drugs has shown efficacy in treating inflammatory bowel disease (IBD) in randomised clinical trials. Vedolizumab is registered since October 2014 in the Netherlands. Here, we describe the clinical experience in 3 centres using vedolizumab for ulcerative colitis (UC) and Crohn’s disease (CD).

Methods

We retrospectively analysed clinical activity and clinical response determined by a composite score based on a VAS scale for pain and fatigue, number of liquid stools, choice of treatment, patient’s ability to work or study, and the conclusion of the attending physician. Further laboratory parameters and the use of vedolizumab was studied.

Results

From October 2014 until November 2015, 48 patients with moderate/severe IBD (mean age 43, 39.6% male, 27; CD and 21 UC patients) were included; 90% had failed at least 1 tumour necrosis factor (TNF) antagonist before treatment. The average duration of disease before treatment with vedolizumab was 9.4 years (range 1–38 years). The average duration of vedolizumab treatment was 25.7 weeks (average 5.6 infusions administered). Concomitant medication included mesalazine (20%), MTX or Thiopurines (20%), Steroids (33%), and 27% was treated with vedolizumab as monotherapy. Further, 27 patients, 56 % (17 CD patients and 10 UC patients) responded to vedolizumab (average 6.8 doses; follow-up 32 weeks) 44% of these responders (7 CD patients and 5 UC patients) reached remission after average 7.2 infusions (41 weeks follow-up). In addition, 15 patients, 31% (7 CD patients, 8 UC patients) were primary non-responders. Moreover, 5 patients, 10% (2 CD patients, 3 UC patients) showed loss of response; 1 of them underwent surgery. In 1 CD patient (2%), vedolizumab was stopped after 1 infusion because of side effects (nasopharyngitis).

Conclusion

In this Dutch real-life IBD cohort with 90% prior anti-TNF failure, vedolizumab showed a 56% response and 25% remission rate without showing major adverse events.