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* = Presenting author

P427 The real-life experience of vedolizumab efficacy and safety in Crohn’s disease: a prospective observational multicentre cohort study

A. Amiot*1, J. C. Grimaud2, X. Treton3, J. Filippi4, B. Pariente5, L. Peyrin-Biroulet6, A. Noureille7, A. Buisson8, F. Carbonnel9, A. Bourrier10, S. Nancey11, X. Roblin12, P. Marteau13, R. Altwegg14, J. Moreau15, A. Aubourg16, G. Savoye17, A. L. Pelletier18, M. Fumery19, B. Bonaz20, Y. Bouhnik3

1Henri Mondor Hospital, Gastroenterology, Creteil, France, 2Hospital Nord, Department of Gastroenterology and Hepatology, Marseille, France, 3APHP Beaujon, Department of Gastroenterology, Clichy, France, 4Archet 2 Hospital, Department of Gastroenterology, Nice, France, 5CHRU Lille, Department of Gastroenterology, Lille, France, 6CHU Nancy, Department of Gastroenterology and Hepatology, Vandoeuvre-Lès-Nancy, France, 7CHU Hotel Dieu, Department of Gastroenterology, Nantes, France, 8CHU Estaing, Department of Gastroenterology, Clermont-Ferrand, France, 9CHU Bicêtre, Department of Gastroenterology, Le Kremlin-Bicêtre, France, 10APHP St. Antoine Hospital, Department of Gastroenterology, Paris, France, 11Hospital Edouard Herriot, Department of Gastroenterology and Hepatology, Lyon, France, 12University of Saint Etienne, Department of Gastroenterology, Saint Etienne, France, 13Hospital Lariboisière, Department of Gastroenterology, Paris, France, 14CHU Montpellier Saint Eloi Hospital, Department of Gastroenterology, Montpellier, France, 15CHU de Toulouse Hospital de Rangueil, Department of Gastroenterology, Toulouse, France, 16Chu Tours, Department of Gastroenterology and Hepatology, Tours, France, 17CHU Rouen, Department of Gastroenterology, Rouen, France, 18Hospital Bichat Claude Bernard, Department of Gastroenterology, Paris, France, 19Amiens University Hospital, Department of Gastroenterology, Amiens, France, 20Grenoble, gastroenterologie, Grenoble, France

Background

Efficacy and safety of VDZ in Crohn’s disease (CD) has been evaluated in 2 large phase 3 randomised controlled trials, leading to the approval of the drug by both EMA and FDA. Herein, we assessed safety and efficacy of VDZ in a large real-life experience cohort of patients with CD.

Methods

All consecutive active CD patients treated with VDZ in France from June to December 2014 were assessed. From June to September, 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 Harvey–Bradshaw index ≤ 4. Response was defined as a reduction in the Harvey–Bradshaw index of at least 3 points. C-reactive protein, as well as safety, were evaluated.

Results

Included were 170 patients (61 males, median age: 36.3 IQR [29.2–47.0] yr) in 31 centres. Median disease duration was 10.7 [6.5–16.5] yr; 165 (97%) patients were previously treated with immunosuppressant; 168 (99%) with at least 1 anti-TNF; and 83 (48.8%) underwent prior intestinal resection. VDZ was given for luminal disease in 91 (53.5%) patients, and for luminal and perianal disease, in 79 (46.5%). At baseline, median Harvey–Bradshaw index was 10 [IQR 7–12] and mean CRP level was 30.5 ± 30.0 mg/L. Steroid-free response rates at W14, W22 and W30 were 51%, 53% and 47%, respectively; the steroid-free remission rates at W14, W22, and W30 were 31%, 39% and 31%, respectively. At W14, the mean decrease of Harvey–Bradshaw index and CRP level were 3.1 ± 4.9 (p < 0.001) and 0.3 ± 40.1 (p = 0.77), respectively. At W14, adverse events were reported in 34 (20%) patients and consisted of opportunistic infection (n = 18, including nasopharyngitis [n = 4], upper respiratory tract infection [n = 4], gastrointestinal infection [n = 4], intraabdominal abscess [n = 2], catheter-related bloodstream infection [n = 2], urinary tract infection [n = 1], herpes zoster ophthalmicus [n = 1], cutaneous reaction [n = 6], paraesthesia [n = 6], infusion reaction [n = 1], headache [n = 2], and rectal adenocarcinoma [n = 1]).

Conclusion

In this first real-life experience cohort of patients with refractory CD, VDZ 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.