• Clin. Gastroenterol. Hepatol. · Feb 2016

    Observational Study

    Subcutaneous Ustekinumab Provides Clinical Benefit for Two-Thirds of Patients With Crohn's Disease Refractory to Anti-Tumor Necrosis Factor Agents.

    • Pauline Wils, Yoram Bouhnik, Pierre Michetti, Bernard Flourie, Hedia Brixi, Anne Bourrier, Matthieu Allez, Bernard Duclos, Jean-Charles Grimaud, Anthony Buisson, Aurélien Amiot, Mathurin Fumery, Xavier Roblin, Laurent Peyrin-Biroulet, Jérôme Filippi, Guillaume Bouguen, Vered Abitbol, Benoit Coffin, Marion Simon, David Laharie, Benjamin Pariente, and Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif.
    • Hepato-Gastroenterology Department, Claude Huriez Hospital, University of Lille 2, Lille, France.
    • Clin. Gastroenterol. Hepatol. 2016 Feb 1; 14 (2): 242-50.e1-2.

    Background & AimsUstekinumab, a human monoclonal antibody against the p40 subunit of interleukins-12 and -23, is effective in inducing and maintaining remission in patients with luminal Crohn's disease (CD). We assessed the efficacy and safety of subcutaneous ustekinumab in patients with anti-tumor necrosis factor (anti-TNF) refractory CD.MethodsWe performed a retrospective observational study, collecting data from the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif on 122 consecutive patients with active CD refractory to anti-TNF therapy who received at least 1 subcutaneous injection of ustekinumab from March 2011 to December 2014, in 20 tertiary centers in Europe. Subjects were followed for at least 3 months. The primary outcome was clinical benefit, defined as reductions in symptoms and biochemical markers of CD and complete weaning from steroids, without surgery or immunosuppressant therapies.ResultsSeventy-nine patients (65%) had a clinical benefit within 3 months of receiving ustekinumab. Concomitant immunosuppressant therapy at study inclusion increased the odds for a clinical benefit from ustekinumab (odds ratio, 5.43; 95% confidence interval, 1.14-25.77; P = .03). Over a median follow-up period of 9.8 months (interquartile range, 5.3-14.5 months), the cumulative probabilities that patients maintained the clinical benefit for 6 and 12 months after introduction of ustekinumab were 93% and 68%, respectively.ConclusionsAlmost two-thirds of patients with CD refractory to at least 1 anti-TNF agent receive clinical benefit from ustekinumab therapy, not requiring steroids for up to 12 months afterward. While awaiting results from ongoing trials, ustekinumab can be considered for use in these patients.Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

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