Aurelien Amiot1, Jean-Charles Grimaud2, Laurent Peyrin-Biroulet3, Jerome Filippi4, Benjamin Pariente5, Xavier Roblin6, Anthony Buisson7, Carmen Stefanescu8, Caroline Trang-Poisson9, Romain Altwegg10, Philippe Marteau11, Thibaud Vaysse12, Anne Bourrier13, Stephane Nancey14, David Laharie15, Matthieu Allez16, Guillaume Savoye17, Jacques Moreau18, Charlotte Gagniere19, Lucine Vuitton20, Stephanie Viennot21, Alexandre Aubourg22, Anne-Laure Pelletier23, Guillaume Bouguen24, Vered Abitbol25, Yoram Bouhnik8. 1. 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. 2. Hôpital Nord, Centre d'Investigation Clinique Marseille Nord, Université Méditerranée, Marseille, France. 3. Inserm U954 and Department of Gastroenterology, Université de Lorraine, Nancy, France. 4. Department of Gastroenterology and Clinical Nutrition, Nice University Hospital, University of Nice Sophia-Antipolis, Nice, France. 5. Department of Gastroenterology, Huriez Hospital, Université Lille Nord de France, Lille, France. 6. Department of Gastroenterology, Saint-Etienne University Hospital, Saint-Etienne, France. 7. Department of Hepato-Gastroenterology, University Hospital Estaing of Clermont-Ferrand, Université d'Auvergne, Clermont-Ferrand, France. 8. Department of Gastroenterology, IBD and Nutrition Support, Beaujon Hospital, University Paris 7 Denis Diderot, Clichy, France. 9. Department of Gastroenterology, Institut des Maladies de l'Appareil Digestif, University Hospital of Nantes, Nantes University, Nantes, France. 10. Department of Gastroenterology, Hôpital Saint-Eloi, University Hospital of Montpellier, Montpellier, France. 11. Medicosurgical Department of Digestive Diseases, Hôpital Lariboisière, AP-HP, University Denis Diderot, Paris, France. 12. Department of Gastroenterology, Bicetre University Hospital, APHP, Université Paris Sud, le Kremlin Bicêtre, Paris, France. 13. Department of Gastroenterology, AP-HP, Hôpital Saint-Antoine, Inserm/UMRS 7203, UPMC Université Paris, Paris, France. 14. Department of Gastroenterology, Hospices Civils de Lyon and University Claude Bernard Lyon 1, Pierre-Benite, France. 15. Department of Hepato-Gastroenterology, University Hospital of Bordeaux, Hôpital Haut-Lévêque, Bordeaux, France. 16. Department of Gastroenterology, Hôpital Saint Louis APHP, Paris, France. 17. Department of Gastroenterology, Rouen University and Hospital, Rouen, France. 18. Department of Gastroenterology, Hôpital Rangueil, University of Toulouse, Toulouse, France. 19. Department of Gastroenterology, Henri Mondor Hospital, Assistance Publique - Hôpitaux de Paris, EC2M3-Equipe Universitaire, Paris Est-Créteil Val de Marne University, Creteil, France. 20. Department of Gastroenterology, Besançon University Hospital, Besançon, France. 21. Department of Gastroenterology, Caen University Hospital, Caen, France. 22. Department of Gastroenterology, Trousseau University Hospital, Tours, France. 23. Department of HepatoGastroenterology, Bichat Hospital, Paris 7 Denis Diderot, Paris, France. 24. Department of Gastroenterology, Pontchaillou Hospital and Rennes University, Rennes, France. 25. Department of Gastroenterology, Cochin Hospital, University Paris 5 Descartes, Paris, France.
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.
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-tumornecrosis 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-tumornecrosis 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: Liege I Diaz; Tara Keihanian; Ingrid Schwartz; Su Bin Kim; Fernando Calmet; Maria Alejandra Quintero; Maria T Abreu Journal: Gastroenterol Hepatol (N Y) Date: 2020-02
Authors: Emily Becker; Sebastian Schramm; Marie-Theres Binder; Clarissa Allner; Maximilian Wiendl; Clemens Neufert; Imke Atreya; Markus Neurath; Sebastian Zundler Journal: J Vis Exp Date: 2018-09-20 Impact factor: 1.355
Authors: B Christensen; D Micic; P R Gibson; A Yarur; E Bellaguarda; P Corsello; J N Gaetano; J Kinnucan; V L Rao; S Reddy; S Singh; J Pekow; D T Rubin Journal: Aliment Pharmacol Ther Date: 2018-01-29 Impact factor: 8.171