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Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease.
- Source :
-
Gastroenterology [Gastroenterology] 2014 Mar; Vol. 146 (3), pp. 681-688.e1. Date of Electronic Publication: 2013 Nov 21. - Publication Year :
- 2014
-
Abstract
- Background & Aims: Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone.<br />Methods: In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50.<br />Results: Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated.<br />Conclusions: The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.<br /> (Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
C-Reactive Protein metabolism
Crohn Disease blood
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Infliximab
Kaplan-Meier Estimate
Male
Middle Aged
Prednisone therapeutic use
Treatment Outcome
Antibodies, Monoclonal therapeutic use
Crohn Disease drug therapy
Methotrexate therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1528-0012
- Volume :
- 146
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Gastroenterology
- Publication Type :
- Academic Journal
- Accession number :
- 24269926
- Full Text :
- https://doi.org/10.1053/j.gastro.2013.11.024