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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 ⁴ Marc-André Bigard ⁴ Xavier Hebuterne ^{34, 5} Maria Nachury ³⁵ Pierre Desreumaux ^{6, 36, 37} Emilie del Tedesco ³⁸ Gilles Bommelaer ³⁶ Arnaud Boureille ³⁹ Xavier Dray ^{40, 13} Franck Carbonnel ⁴¹ Philippe Seksik ⁴² Laurent Beaugerie ⁴² Jacques Cosnes ^{15, 16} Harry Sokol ⁴² Cecilia Landman ^{15, 16} Gilles Boschetti ⁴³ Florian Poullenot ⁴⁴ Jean-Marc Gornet ²⁰ Clautilde Baudry ⁴⁵ Stéphane Koch ⁴⁶ Laurence Picon ⁴⁷ Gaelle Sickersen ⁴⁸ Stanislas Chaussade ⁴⁹ Stephane Nahon ⁵⁰ Betsy Winkfield ^{51, 52} Hedia Brixi-Benmansour ⁵² Rodica Gincul ⁵³ Jean-Christophe Barberis ⁵¹ Bruno Bonaz ⁵⁴ Christophe Michiels ⁵¹ Franck Zerbib ¹⁹ Marie Bourrier De Beauregard ⁵¹ Christophe Locher ⁵⁵ Sophie Davin-Couve ⁵¹ Armelle Poirette ⁵¹ Laurence Guillem ⁵¹ Monica Stetiu-Mocanu ⁵¹ Sylvain Beorchia ⁵¹ Jawad Al Qaddi ⁵¹

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 Service de rhumatologie [CHU Saint-Antoine]

17 HCL - Hospices Civils de Lyon

18 UCBL - Université Claude Bernard Lyon 1

19 Service d'Hépato-Gastro-Entérologie

20 AP-HP - Hopital Saint-Louis [AP-HP]

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 de 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 (1965 - 2019)

35 Hôpital Claude Huriez [Lille]

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

37 Université de Lille, Droit et Santé

38 Service d'Hépato-gastroentérologie [CHU Saint-Etienne]

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

40 ASTRE [Cergy-Pontoise]

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

41 AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)

42 CHU Saint-Antoine [AP-HP]

43 Service d'Hépatologie et de Gastroentérologie [Lyon]

44 Hôpital Haut-Lévêque [CHU Bordeaux]

45 Service d'Endocrinologie, Diabétologie, Maladies Métaboliques, Hôpital Avicenne

46 Wallenberg Centre for Molecular Medicine (WCMM)

47 Hépato-Gastro-Onco-Entérologie [CHRU de Tours]

48 Service d'hépato-gastro-entérologie [Hôpital Saint-Louis, APHP]

49 Service de Gastro-entérologie et hépatologie [AP-HP Hôpital Cochin]

50 Service d’hépato-gastro-entérologie [CH Le Raincy-Montfermeil]

51 Observatory on Efficacy and of Vedolizumab in Patients With Inflammatory Bowel Disease Study Group

52 GETAID - Groupe d’Étude Thérapeutique des Affections Inflammatoires du Tube Digestif

53 Hôpital Edouard Herriot [CHU - HCL]

54 Stress et Interactions neuro-digestives

GIN - [GIN] Grenoble Institut des Neurosciences

55 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 : drug inhibitor cell adhesion IBD

Document type :

Journal articles

Domain :

Life Sciences [q-bio]

Complete list of metadata

https://hal-univ-rennes1.archives-ouvertes.fr/hal-01278611
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Submitted on : Wednesday, February 24, 2016 - 3:33:37 PM
Last modification on : Friday, September 9, 2022 - 10:22:07 AM