title: Effectiveness and Safety of Vedolizumab Induction Therapy for Patients With Inflammatory Bowel Disease.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Department of Gastroenterology, Henri Mondor Hospital, Assistance Publique - Hôpitaux de Paris, EC2M3-Equipe Universitaire, Paris Est-Créteil Val de Marne University, Creteil, France. Electronic address: aurelien.amiot@hmn.aphp.fr.
authors.forename: Aurelien
authors.initials: A
authors.lastname: Amiot
authors.affiliation: Hôpital Nord, Centre d'Investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Grimaud
authors.affiliation: Inserm U954 and Department of Gastroenterology, Université de Lorraine, Nancy, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Peyrin-Biroulet
authors.affiliation: Department of Gastroenterology and Clinical Nutrition, Nice University Hospital, University of Nice Sophia-Antipolis, Nice, France.
authors.forename: Jerome
authors.initials: J
authors.lastname: Filippi
authors.affiliation: Department of Gastroenterology, Huriez Hospital, Université Lille Nord de France, Lille, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Pariente
authors.affiliation: Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Roblin
authors.affiliation: Department of Hepato-Gastroenterology, University Hospital Estaing of Clermont-Ferrand, Université d'Auvergne, Clermont-Ferrand, France.
authors.forename: Anthony
authors.initials: A
authors.lastname: Buisson
authors.affiliation: Department of Gastroenterology, IBD and Nutrition Support, Beaujon Hospital, University Paris 7 Denis Diderot, Clichy, France.
authors.forename: Carmen
authors.initials: C
authors.lastname: Stefanescu
authors.affiliation: Department of Gastroenterology, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes University, Nantes, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Trang-Poisson
authors.affiliation: Department of Gastroenterology, Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France.
authors.forename: Romain
authors.initials: R
authors.lastname: Altwegg
authors.affiliation: Medicosurgical Department of Digestive Diseases, Hôpital Lariboisière, AP-HP, University Denis Diderot, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Marteau
authors.affiliation: Department of Gastroenterology, Bicetre University Hospital, APHP, Université Paris Sud, le Kremlin Bicêtre, Paris, France.
authors.forename: Thibaud
authors.initials: T
authors.lastname: Vaysse
authors.affiliation: Department of Gastroenterology, AP-HP, Hôpital Saint-Antoine, Inserm/UMRS 7203, UPMC Université Paris, Paris, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Bourrier
authors.affiliation: Department of Gastroenterology, Hospices Civils de Lyon and University Claude Bernard Lyon 1, Pierre-Benite, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Nancey
authors.affiliation: Department of Hepato-Gastroenterology, University Hospital of Bordeaux, Hôpital Haut-Lévêque, Bordeaux, France.
authors.forename: David
authors.initials: D
authors.lastname: Laharie
authors.affiliation: Department of Gastroenterology, Hôpital Saint Louis APHP, Paris, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Allez
authors.affiliation: Department of Gastroenterology, Rouen University and Hospital, Rouen, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Savoye
authors.affiliation: Department of Gastroenterology, Hôpital Rangueil, University of Toulouse, Toulouse, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Moreau
authors.affiliation: Department of Gastroenterology, Henri Mondor Hospital, Assistance Publique - Hôpitaux de Paris, EC2M3-Equipe Universitaire, Paris Est-Créteil Val de Marne University, Creteil, France.
authors.forename: Charlotte
authors.initials: C
authors.lastname: Gagniere
authors.affiliation: Department of Gastroenterology, Besançon University Hospital, Besançon, France.
authors.forename: Lucine
authors.initials: L
authors.lastname: Vuitton
authors.affiliation: Department of Gastroenterology, Caen University Hospital, Caen, France.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Viennot
authors.affiliation: Department of Gastroenterology, Trousseau University Hospital, Tours, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Aubourg
authors.affiliation: Department of HepatoGastroenterology, Bichat Hospital, Paris 7 Denis Diderot, Paris, France.
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Pelletier
authors.affiliation: Department of Gastroenterology, Pontchaillou Hospital and Rennes University, Rennes, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Bouguen
authors.affiliation: Department of Gastroenterology, Cochin Hospital, University Paris 5 Descartes, Paris, France.
authors.forename: Vered
authors.initials: V
authors.lastname: Abitbol
authors.affiliation: Department of Gastroenterology, IBD and Nutrition Support, Beaujon Hospital, University Paris 7 Denis Diderot, Clichy, France.
authors.forename: Yoram
authors.initials: Y
authors.lastname: Bouhnik
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; C543529:vedolizumab
keywords: Cell Adhesion; Drug; IBD; Inhibitor