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* = Presenting author

P306 The real-life experience of vedolizumab efficacy and safety in ulcerative colitis: a prospective observational multicentre cohort study

A. Amiot*1, L. Peyrin-Biroulet2, C. Stefanescu3, J. C. Grimaud4, J. Filippi5, B. Pariente6, X. Roblin7, R. Altwegg8, D. Laharie9, P. Marteau10, A. Buisson11, C. Trang-Poisson12, S. Nancey13, G. Savoye14, S. Viennot15, H. Brixi-Benmansour16, F. Carbonnel17, Y. Bouhnik3

1Henri Mondor Hospital, Gastroenterology, Creteil, France, 2CHU Nancy, Department of Gastroenterology and Hepatology, Vandoeuvre-Lès-Nancy, France, 3APHP Beaujon, Department of Gastroenterology, Clichy, France, 4Hospital Nord, Department of Gastroenterology and Hepatology, Marseille, France, 5Archet 2 Hospital, Department of Gastroenterology, Nice, France, 6CHRU Lille, Department of Gastroenterology, Lille, France, 7University of Saint Etienne, Department of Gastroenterology, Saint Etienne, France, 8CHU Montpellier Saint Eloi Hospital, Department of Gastroenterology, Montpellier, France, 9CHU Bordeaux, Department of Gastroenterology, Bordeaux, France, 10Hospital Lariboisière, Department of Gastroenterology, Paris, France, 11CHU Estaing, Department of Gastroenterology, Clermont-Ferrand, France, 12CHU Hotel Dieu, Department of Gastroenterology, Nantes, France, 13Hospital Edouard Herriot, Department of Gastroenterology and Hepatology, Lyon, France, 14CHU Rouen, Department of Gastroenterology, Rouen, France, 15Hospital Cote de Nacre, Department of Gastroenterology, Caen Cede, France, 16Robert Debre Hospital, Department of Gastroenterology, Reims, France, 17CHU Bicêtre, Department of Gastroenterology, Le Kremlin-Bicêtre, France

Background

Vedolizumab (VDZ) is a humanised monoclonal antibody that specifically antagonises α4β7 integrin by inhibiting its binding to the gut-specific intestinal mucosal address in MAdCAM 1. Efficacy and safety of VDZ in ulcerative colitis (UC) has been evaluated in 1 large phase 3 randomised controlled trial (GEMINI I), leading to the approval of the drug by both European Medicines Authority (EMA) and Food and Drug Administration (FDA). Herein, we assessed safety and efficacy of VDZ in a large real-life experience cohort of patients with UC.

Methods

All consecutive active, non-operated UC patients treated with VDZ in France from June to December 2014 were assessed. From June to September 2014, VDZ was available through a centralised pre-approval programme piloted by the French regulatory agency (ANSM). After its approval by ANSM (reimbursement of the drug by social services is still pending), recruitment was extended until December 2014. Patients received VDZ (at a dose of 300 mg) at weeks 0, 2, and 6 as induction therapy and then every 8 weeks. Patients who did not respond to VDZ induction therapy at week 6 could receive VDZ 300 mg every 4 weeks. Patients were evaluated prospectively through W52. Remission was defined as a partial Mayo score < 2. Response was defined as a reduction in the partial Mayo score of at least 3 points and a decrease of at least 30% from baseline. C-reactive protein, as well as safety, was ascertained.

Results

In total, 121 patients (67 males, median age: 40.4 IQR [29.7–55.2] years) were included in 33 centres. Median disease duration was 6.5 [3.8–11.4] years; 115 (95%) patients were previously treated with immunosuppressants and 116 (96%) with at least 1 anti-TNF. At baseline, median total Mayo score was 9 (IQR 8–12) and mean CRP level was 19.4 ± 21.1 mg/L. Steroid-free response rates at W14, W22, and W30 were 50%, 50%, and 54%, respectively; the steroid-free remission rates at W14, W22, and W30 were 36%, 39%, and 39%, respectively. At W14, the mean decrease of partial Mayo score and CRP level was 2.5 ± 2.8 (p < 0.001) and 3.8 ± 22.5 (p = 0.02), respectively. At W14, adverse events were reported in 22 (18%) patients and consisted of opportunistic infection (n = 13, including nasopharyngitis [n = 6], upper respiratory tract infection [n = 4], Clostridium difficile superinfection [n = 1], cholecystitis [n = 1], and tuberculosis [n = 1]), cutaneous reaction (n = 5), paraesthesia (n = 2), strokes (n = 1), and deep venous thrombosis (n = 1).

Conclusion

In this first real-life experience cohort of patients with refractory UC, vedolizumab-induced steroid-free clinical remission in one-third of the cases at W14, with an acceptable safety profile. The efficacy of VDZ remained stable through W30 and will be assessed in January 2016 through W52.