Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease

Aurelien Amiot; Jean-Charles Grimaud; Laurent Peyrin-Biroulet; Jérome Filippi; Benjamin Pariente; Xavier Roblin; Anthony Buisson; Carmen Stefanescu; Caroline Trang-Poisson; Romain Altwegg; Philippe Marteau; Thibaud Vaysse; Anne Bourrier; Stéphane Nancey; David Laharie; Matthieu Allez; Guillaume Savoye; Jacques Moreau; Charlotte Gagniere; Lucine Vuitton; Stephanie Viennot; Alexandre Aubourg; Anne-Laure Pelletier; Guillaume Bouguen; Vered Abitbol; Yoram Bouhnik; Camille Zallot; Marc-André Bigard; Xavier Hebuterne; Maria Nachury; Pierre Desreumaux; Emilie del Tedesco; Gilles Bommelaer; Arnaud Boureille; Xavier Dray; Franck Carbonnel; Philippe Seksik; Laurent Beaugerie; Jacques Cosnes; Harry Sokol; Cecilia Landman; Gilles Boschetti; Florian Poullenot; Jean-Marc Gornet; Clautilde Baudry; Stéphane Koch; Laurence Picon; Gaelle Sickersen; Stanislas Chaussade; Stephane Nahon; Betsy Winkfield; Hedia Brixi-Benmansour; Rodica Gincul; Jean-Christophe Barberis; Bruno Bonaz; Christophe Michiels; Franck Zerbib; Marie Beauregard; Christophe Locher; Sophie Davin-Couve; Armelle Poirette; Laurence Guillem; Monica Stetiu-Mocanu; Sylvain Beorchia; Jawad Al Qaddi

doi:10.1016/j.cgh.2016.02.016

Journal articles

Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease

Aurelien Amiot ^{1, 2} Jean-Charles Grimaud ³ Laurent Peyrin-Biroulet ⁴ Jérome Filippi ⁵ Benjamin Pariente ⁶ Xavier Roblin ⁷ Anthony Buisson ⁸ Carmen Stefanescu ^{9, 10} Caroline Trang-Poisson ¹¹ Romain Altwegg ¹² Philippe Marteau ¹³ Thibaud Vaysse ¹⁴ Anne Bourrier ^{15, 16} Stéphane Nancey ^{17, 18} David Laharie ¹⁹ Matthieu Allez ²⁰ Guillaume Savoye ^{21, 22, 23} Jacques Moreau ²⁴ Charlotte Gagniere ^{1, 2} Lucine Vuitton ²⁵ Stephanie Viennot ²⁶ Alexandre Aubourg ^{27, 28} Anne-Laure Pelletier ²⁹ Guillaume Bouguen ^{30, 31, 32} Vered Abitbol ³³ Yoram Bouhnik ^{9, 10} Camille Zallot Marc-André Bigard ⁴ Xavier Hebuterne ^{34, 5} Maria Nachury Pierre Desreumaux ^{6, 35, 36} Emilie del Tedesco Gilles Bommelaer ³⁵ Arnaud Boureille ³⁷ Xavier Dray ^{38, 13} Franck Carbonnel Philippe Seksik ³⁹ Laurent Beaugerie ³⁹ Jacques Cosnes ^{15, 16} Harry Sokol ³⁹ Cecilia Landman ^{15, 16} Gilles Boschetti Florian Poullenot Jean-Marc Gornet Clautilde Baudry Stéphane Koch Laurence Picon Gaelle Sickersen Stanislas Chaussade Stephane Nahon Betsy Winkfield Hedia Brixi-Benmansour Rodica Gincul ⁴⁰ Jean-Christophe Barberis Bruno Bonaz ⁴¹ Christophe Michiels Franck Zerbib ¹⁹ Marie Beauregard Christophe Locher ⁴² Sophie Davin-Couve Armelle Poirette Laurence Guillem Monica Stetiu-Mocanu Sylvain Beorchia Jawad Al Qaddi

1 LIC - Laboratoire d'Investigation Clinique

2 EC2M3 - Early detection of Colon Cancer using Molecular Markers and Microbiota (EA 7375)

3 AMU MED - Aix-Marseille Université - Faculté de médecine

4 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux

5 CHU Nice - Centre Hospitalier Universitaire de Nice

6 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]

7 CHU de Saint-Etienne - Centre Hospitalier Universitaire de Saint-Etienne

8 CHU Clermont-Ferrand

9 Service de Gastroentérologie [Hôpital Beaujon]

10 UPD7 - Université Paris Diderot - Paris 7

11 Institut des Maladies de l'Appareil Digestif

12 Département d'Hépato-Gastroentérologie et de Transplantation Hépatique [CHU Saint-Eloi]

13 AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)

14 Service de neurologie [Le Kremlin Bicêtre]

15 Service de Gastroentérologie et nutrition [CHU Saint-Antoine]

16 DHU i2B - Service de rhumatologie, inflammation-immunopathologie- biothérapie [CHU Saint-Antoine]

17 HCL - Hospices Civils de Lyon

18 UCBL - Université Claude Bernard Lyon 1

19 Service d'Hépato-Gastro-Entérologie

20 Hôpital Saint-Louis

21 ADEN - Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau

22 UNIROUEN - Université de Rouen Normandie

23 IRIB - Institute for Research and Innovation in Biomedicine

24 CHU Toulouse [Toulouse]

25 CHRU Besançon - Centre Hospitalier Régional Universitaire [Besançon]

26 Service d'Hépato-Gastro-Enterologie et Nutrition [CHU Caen]

27 GICC UMR 7292 CNRS - Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017]

28 CHU Trousseau [Tours]

29 AP-HP - Hôpital Bichat - Claude Bernard [Paris]

30 Foie, métabolismes et cancer

31 Hôpital Pontchaillou

32 UNIV-RENNES - Université de Rennes

33 AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris]

34 UNS - Université Nice Sophia Antipolis (... - 2019)

35 INSERM - Institut National de la Santé et de la Recherche Médicale

36 Université de Lille, Droit et Santé

37 Neuropathies du système nerveux entérique et pathologies digestives; implication des cellules gliales entériques

38 ASTRE [Cergy-Pontoise]

ETIS - UMR 8051 - Equipes Traitement de l'Information et Systèmes

39 CHU Saint-Antoine [AP-HP]

40 Hôpital Edouard Herriot [CHU - HCL]

41 Equipe 8 : Stress et Interactions neuro-digestives

UJF - Université Joseph Fourier - Grenoble 1, CEA - Commissariat à l'énergie atomique et aux énergies alternatives, INSERM - Institut National de la Santé et de la Recherche Médicale : U836, [GIN] Grenoble Institut des Neurosciences

42 Centre Hospitalier de Meaux

Abstract : Background & aims - Phase 3 trials have shown the efficacy of vedolizumab, which binds to integrin α4β7, in patients with Crohn's disease (CD) or ulcerative colitis (UC). We investigated the effectiveness and safety of vedolizumab in patients who failed anti-tumor necrosis factor therapy. Methods - From June through December 2014, there were 173 patients with CD and 121 patients with UC who were included in a multicenter nominative compassionate early access program granted by French regulatory agencies. This program provided patients with access to vedolizumab before it was authorized for marketing. Vedolizumab (300 mg) was administered intravenously at weeks 0, 2, and 6, and then every 8 weeks. Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. We report results obtained after the 14-week induction phase. Results - Among the 294 patients treated with vedolizumab (mean age, 39.5 ± 14.0 y; mean disease duration, 10.8 ± 7.6 y; concomitant steroids, 44% of cases), 276 completed the induction period, however, 18 discontinued vedolizumab because of a lack of response (n = 14), infusion-related reaction (n = 2), or infections (n = 2). At week 14, 31% of patients with CD were in steroid-free clinical remission and 51% had a response; among patients with UC, 36% were in steroid-free clinical remission and 50% had a response. No deaths were reported. Severe adverse events occurred in 24 patients (8.2%), including 15 (5.1%) that led to vedolizumab discontinuation (1 case of pulmonary tuberculosis and 1 rectal adenocarcinoma). Conclusions - In a cohort of patients with CD or UC who failed previous anti-tumor necrosis factor therapy, approximately one third of patients achieved steroid-free clinical remission after 14 weeks of induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients.

Keywords : IBD drug inhibitor cell adhesion

Document type :

Journal articles

Domain :

Life Sciences [q-bio]

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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01278611
Contributor : Nelly Brenner <>
Submitted on : Wednesday, February 24, 2016 - 3:33:37 PM
Last modification on : Wednesday, October 14, 2020 - 3:50:36 AM

Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease

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Effectiveness and Safety of Vedolizumab Induction Therapy for Patients with Inflammatory Bowel Disease

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