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

Details

Serval ID
serval:BIB_9B840707F152
Type
Article: article from journal or magazin.
Collection
Publications
Title
Subcutaneous Ustekinumab Provides Clinical Benefit for Two-Thirds of Patients With Crohn's Disease Refractory to Anti-Tumor Necrosis Factor Agents.
Journal
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Author(s)
Wils P., Bouhnik Y., Michetti P., Flourie B., Brixi H., Bourrier A., Allez M., Duclos B., Grimaud J.C., Buisson A., Amiot A., Fumery M., Roblin X., Peyrin-Biroulet L., Filippi J., Bouguen G., Abitbol V., Coffin B., Simon M., Laharie D., Pariente B.
Working group(s)
Groupe d'Etude Thérapeutique des Affections Inflammatoires du Tube Digestif
ISSN
1542-7714 (Electronic)
ISSN-L
1542-3565
Publication state
Published
Issued date
02/2016
Peer-reviewed
Oui
Volume
14
Number
2
Pages
242-50.e1-2
Language
english
Notes
Publication types: Journal Article ; Observational Study
Publication Status: ppublish
Abstract
Ustekinumab, 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.
We 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.
Seventy-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.
Almost 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.

Keywords
Adult, Crohn Disease/drug therapy, Europe, Female, Humans, Immunologic Factors/adverse effects, Immunologic Factors/therapeutic use, Injections, Subcutaneous/adverse effects, Male, Retrospective Studies, Treatment Outcome, Tumor Necrosis Factor-alpha/therapeutic use, Ustekinumab/adverse effects, Ustekinumab/therapeutic use
Pubmed
Create date
11/03/2016 11:10
Last modification date
20/08/2019 15:02
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