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

Amiot A1, Grimaud JC2, Peyrin-Biroulet L3, Filippi J4, Pariente B5, Roblin X6, Buisson A7, Stefanescu C8, Trang-Poisson C9, Altwegg R10, Marteau P11, Vaysse T12, Bourrier A13, Nancey S14, Laharie D15, Allez M16, Savoye G17, Moreau J18, Gagniere C19, Vuitton L20, Viennot S21, Aubourg A22, Pelletier AL23, Bouguen G24, Abitbol V25, Bouhnik Y8; OBSERV-IBD study group and the GETAID. Clin Gastroenterol Hepatol. 2016 Feb 22. pii: S1542-3565(16)00164-6. doi: 10.1016/j.cgh.2016.02.016. [Epub ahead of print]
Collaborators (64)

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1Department of Gastroenterology, Henri Mondor Hospital, APHP, EC2M3-Equipe Universitaire, Paris Est-Créteil (UPEC) Val de Marne University, Creteil, France. Electronic address: aurelien.amiot@hmn.aphp.fr. 2Hôpital Nord, Centre d'investigation clinique Marseille Nord, Université Méditerranée, Marseille, France. 3Inserm U954 and Department of Gastroenterology, Université de Lorraine, Nancy, France. 4Department of Gastroenterology and Clinical Nutrition, Nice University Hospital, University of Nice Sophia-Antipolis, Nice, France. 5Department of Gastroenterology, Huriez Hospital, Université Lille Nord de France, Lille, France. 6Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France. 7Department of Hepato-Gastroenterology, University Hospital Estaing of Clermont-Ferrand, Université d'Auvergne, Clermont-Ferrand, France. 8Department of Gastroenterology, IBD and Nutrition Support, Beaujon Hospital, University Paris 7 Denis Diderot, Clichy, France. 9Department of Gastroenterology, Institut des Maladies de l'appareil Digestif (IMAD), University Hospital of Nantes, Nantes University, Nantes, France. 10Department of Gastroenterology, Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France. 11Medicosurgical Department of Digestive Diseases, Hôpital Lariboisière, AP-HP, University Denis Diderot, Paris, France. 12Department of Gastroenterology, Bicetre University Hospital, APHP, Université Paris Sud, le Kremlin Bicêtre, Paris, France. 13Department of Gastroenterology, AP-HP, Hôpital Saint-Antoine, F-75012, ERL 1057 Inserm/UMRS 7203, UPMC Université Paris 06 F-75005, Paris, France. 14Department of Gastroenterology, Hospices Civils de Lyon and University Claude Bernard Lyon 1, Pierre-Benite, France. 15Department of Hepato-Gastroenterology, University Hospital of Bordeaux, Hôpital Haut-Lévêque, Bordeaux, France. 16Department of Gastroenterology, Hôpital Saint Louis APHP, Paris, France. 17Department of Gastroenterology, Rouen University and Hospital, Rouen, France. 18Department of Gastroenterology, Hôpital Rangueil, University of Toulouse, Toulouse, France. 19Department of Gastroenterology, Henri Mondor Hospital, APHP, EC2M3-Equipe Universitaire, Paris Est-Créteil (UPEC) Val de Marne University, Creteil, France. 20Department of Gastroenterology, Besançon University Hospital, Besançon, France. 21Department of Gastroenterology, Caen University Hospital, F-14000, Caen, France. 22Department of Gastroenterology, Trousseau University Hospital, Tours, France. 23Department of HepatoGastroenterology, Bichat Hospital, Paris 7 Denis Diderot, Paris, France. 24Department of Gastroenterology, Pontchaillou Hospital and Rennes University, Rennes, France. 25Department of Gastroenterology, Cochin Hospital, University Paris 5 Descartes, Paris, France.


BACKGROUND & AIMS: Phase 3 trials have demonstrated 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 a patients who failed anti-tumor necrosis factor (TNF) therapy.

METHODS: From June through December 2014, 173 patients with Crohn's disease (CD) and 121 with ulcerative colitis (UC) were included in a multicenter nominative compassionate early-access program granted by French regulatory agencies. This program provided patients 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 years; mean disease duration, 10.8 ± 7.6 years; concomitant steroid in 44% of cases), 276 completed the induction period whereas 18 discontinued vedolizumab because of 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).

CONCLUSION: In a cohort of patients with CD or UC who failed previous anti-TNF therapy, about one third of patients achieved steroid-free clinical remission following 14 weeks induction therapy with vedolizumab. This agent had an acceptable safety profile in these patients.

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