Martine De Vos1, Barbara Dhooghe1, Severine Vermeire2, Edouard Louis3, Fazia Mana4, Ann Elewaut5, Peter Bossuyt6, Filip Baert7, Catherine Reenaers3, Marc Van Gossum8, Elisabeth Macken9, Marc Ferrante2, Pieter Hindryckx1, Olivier Dewit10, Tom Holvoet1, Denis Franchimont8. 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.
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.
Authors: Mark S Silverberg; Jack Satsangi; Tariq Ahmad; Ian D R Arnott; Charles N Bernstein; Steven R Brant; Renzo Caprilli; Jean-Frédéric Colombel; Christoph Gasche; Karel Geboes; Derek P Jewell; Amir Karban; Edward V Loftus; A Salvador Peña; Robert H Riddell; David B Sachar; Stefan Schreiber; A Hillary Steinhart; Stephan R Targan; Severine Vermeire; B F Warren Journal: Can J Gastroenterol Date: 2005-09 Impact factor: 3.522
Authors: Emily E Vivio; Navya Kanuri; Joanna J Gilbertsen; Kelly Monroe; Neelendu Dey; Chien-Huan Chen; Alexandra M Gutierrez; Matthew A Ciorba Journal: J Crohns Colitis Date: 2015-12-17 Impact factor: 9.071
Authors: James D Lewis; Shaokun Chuai; Lisa Nessel; Gary R Lichtenstein; Faten N Aberra; Jonas H Ellenberg Journal: Inflamm Bowel Dis Date: 2008-12 Impact factor: 5.325
Authors: Brian G Feagan; Paul Rutgeerts; Bruce E Sands; Stephen Hanauer; Jean-Frédéric Colombel; William J Sandborn; Gert Van Assche; Jeffrey Axler; Hyo-Jong Kim; Silvio Danese; Irving Fox; Catherine Milch; Serap Sankoh; Tim Wyant; Jing Xu; Asit Parikh Journal: N Engl J Med Date: 2013-08-22 Impact factor: 91.245
Authors: Bharati Kochar; Yue Jiang; Aaron Winn; Edward L Barnes; Christopher F Martin; Millie D Long; Michael D Kappelman Journal: Crohns Colitis 360 Date: 2019-08-29
Authors: Renske Wilhelmina Maria Pauwels; Annemarie Charlotte de Vries; Christien Janneke van der Woude Journal: J Gastroenterol Hepatol Date: 2020-05-04 Impact factor: 4.029