Title :

Methotrexate is not superior to placebo for inducing steroid-free remission, but induces steroid-free clinical remission in a larger proportion of patients with ulcerative colitis

Author(s) :

Carbonnel, Franck [Auteur]
Colombel, Jean Frederic [Auteur]
Filippi, Jerome [Auteur]
Katsanos, Konstantinos H. [Auteur]
Peyrin-Biroulet, Laurent [Auteur]
Allez, Mathieu [Auteur]
Nachury, Maria [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Lille Inflammation Research International Center - U 995 [LIRIC]
Novacek, Gottfried [Auteur]
Danese, Silvio [Auteur]
Abitbol, Vered [Auteur]
Bossa, Fabrizio [Auteur]
Moreau, Jacques [Auteur]
Bommelaer, Gilles [Auteur]
Bourreille, Arnaud [Auteur]
Fumery, Mathurin [Auteur]
Roblin, Xavier [Auteur]
Reinisch, Walter [Auteur]
Bouhnik, Yoram [Auteur]
Brixi, Hedia [Auteur]
Seksik, Philippe [Auteur]
Malamut, Georgia [Auteur]
Farkkila, Martti [Auteur]
Coulibaly, Baya [Auteur]
Dewit, Olivier [Auteur]
Louis, Edouard [Auteur]
Deplanque, Dominique [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Troubles cognitifs dégénératifs et vasculaires - U1171
Michetti, Pierre [Auteur]
Sarter, Helene [Auteur]
Laharie, David [Auteur]

Journal title :

Gastroenterology

Abbreviated title :

Gastroenterology

Volume number :

150

Pages :

380-+

Publication date :

2016-02-01

ISSN :

0016-5085

English keyword(s) :

IBD
Methotrexate
Clinical Trial
Drug

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

OBJECTIVE: Parenteral methotrexate is an effective treatment for patients with Crohn's disease, but has never been adequately evaluated in patients with ulcerative colitis (UC). We conducted a randomized controlled trial ...
Show more >OBJECTIVE: Parenteral methotrexate is an effective treatment for patients with Crohn's disease, but has never been adequately evaluated in patients with ulcerative colitis (UC). We conducted a randomized controlled trial to determine its safety and efficacy in patients with steroid-dependent UC. METHODS: We performed a double-blind, placebo-controlled trial to evaluate the efficacy of parenteral methotrexate (25 mg/wk) in 111 patients with corticosteroid-dependent UC at 26 medical centers in Europe from 2007 through 2013. Patients were given prednisone (10 to 40 mg/d) when the study began and were randomly assigned to groups (1:1) given placebo or methotrexate (intramuscularly or subcutaneously, 25 mg weekly) for 24 weeks. The primary end point was steroid-free remission (defined as a Mayo score ≤2 with no item >1 and complete withdrawal of steroids) at week 16. Secondary endpoints included clinical remission (defined as a Mayo clinical subscore ≤2 with no item >1) and endoscopic healing without steroids at weeks 16 and/or 24, remission without steroids at week 24, and remission at both weeks 16 and 24. RESULTS: Steroid-free remission at week 16 was achieved by 19 of 60 patients given methotrexate (31.7%) and 10 of 51 patients given placebo (19.6%)--a difference of 12.1% (95% confidence interval [CI]: -4.0% to 28.1%; P = .15). The proportion of patients in steroid-free clinical remission at week 16 was 41.7% in the methotrexate group and 23.5% in the placebo group, for a difference of 18.1% (95% CI: 1.1% to 35.2%; P = .04). The proportions of patients with steroid-free endoscopic healing at week 16 were 35% in the methotrexate group and 25.5% in the placebo group--a difference of 9.5% (95% CI: -7.5% to 26.5%; P = .28). No differences were observed in other secondary end points. More patients receiving placebo discontinued the study because of adverse events (47.1%), mostly caused by UC, than patients receiving methotrexate (26.7%; P = .03). A higher proportion of patients in the methotrexate group had nausea and vomiting (21.7%) than in the placebo group (3.9%; P = .006). CONCLUSIONS: In a randomized controlled trial, parenteral methotrexate was not superior to placebo for induction of steroid-free remission in patients with UC. However, methotrexate induced clinical remission without steroids in a significantly larger percentage of patients, resulting in fewer withdrawals from therapy due to active UC. ClinicalTrials.gov ID NCT00498589.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

CHU Lille
CNRS
Inserm
Université de Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Submission date :

2019-11-27T14:31:32Z