Efficacy of vedolizumab for induction of clinical response and remission in patients with moderate to severe inflammatory bowel disease who failed at least two TNF antagonists

Author:

De Vos Martine1,Dhooghe Barbara1,Vermeire Severine2,Louis Edouard3,Mana Fazia4,Elewaut Ann5,Bossuyt Peter6,Baert Filip7,Reenaers Catherine3,Van Gossum Marc8,Macken Elisabeth9,Ferrante Marc2,Hindryckx Pieter1,Dewit Olivier10,Holvoet Tom1,Franchimont Denis8,

Affiliation:

1. Department of Gastroenterology and Hepatology, University Hospital Ghent, Belgium

2. Departments of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Belgium

3. Department of Gastroenterology, University Hospital of Liège, Belgium

4. Department of Gastroenterology, University Hospital Brussels (Jette), Belgium

5. Department of Gastroenterology, AZ Groeninge, Kortrijk, Belgium

6. Imelda GI Clinical Research Centre, Imeldaziekenhuis Bonheiden, Belgium

7. Department of Gastroenterology, AZ Delta, Roeselare, Belgium

8. Department of Gastroenterology, ULB Erasme, Brussels, Belgium

9. Department of Gastroenterology, University Hospital Antwerp, Belgium

10. Department of Hepato-Gastro-Enterology, Cliniques Universitaires Saint-Luc, Brussels, Belgium

Abstract

Background Vedolizumab is a recently available monoclonal antibody targeting α4β7 integrin for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). Objective The objective of this article is to evaluate the efficacy of vedolizumab induction therapy in anti-TNF-refractory/intolerant UC and CD patients in real life. Methods A cohort of 149 moderately to severely active UC and CD patients who failed or showed intolerance to at least two TNF antagonists participated in a medical need program and received vedolizumab in 37 Belgian centers (April–September 2015). Rates of clinical response and remission were retrospectively evaluated at Week 10 for UC and Week 14 for CD using the physician’s global assessment (PGA), Mayo score and Harvey Bradshaw index (HBI) or Crohn's disease activity score (CDAI) scores. Results Eighty-four patients (29 UC, 55 CD) had sufficient data for analysis. For UC patients, clinical response was observed in 76% based on PGA and 59% based on the Mayo score. The corresponding percentages for CD patients were 80% for PGA and 65% for HBI/CDAI. Clinical remission rates were 10% and 40% for UC and CD, respectively. Steroid-free remission was observed in respectively 10% and 35%. Globally, corticosteroids were stopped in 14 out of 48 patients (29%). No new safety signals were reported. Conclusion Up to 70% TNF-refractory/intolerant UC and CD patients achieved a clinical response after 10 to 14 weeks of vedolizumab treatment in this real-life cohort.

Publisher

Wiley

Subject

Gastroenterology,Oncology

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