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Methotrexate in Combination With Infliximab Is No More Effective Than Infliximab Alone in Patients With Crohn's Disease

Authors
  • Feagan, Brian G.
  • McDonald, John W.D.
  • Panaccione, Remo
  • Enns, Robert A.
  • Bernstein, Charles N.
  • Ponich, Terry P.
  • Bourdages, Raymond
  • MacIntosh, Donald G.
  • Dallaire, Chrystian
  • Cohen, Albert
  • Fedorak, Richard N.
  • Paré, Pierre
  • Bitton, Alain
  • Saibil, Fred
  • Anderson, Frank
  • Donner, Allan
  • Wong, Cindy J.
  • Zou, Guangyong
  • Vandervoort, Margaret K.
  • Hopkins, Marybeth
  • And 1 more
  • 1 Robarts Clinical Trials
  • 2 Western University
  • 3 Department of Medicine
  • 4 Department of Epidemiology and Biostatistics
  • 5 Inflammatory Bowel Disease Clinic
  • 6 University of Calgary
  • 7 St. Paul's Hospital
  • 8 University of British Columbia
  • 9 Health Sciences Centre
  • 10 University of Manitoba
  • 11 London Health Sciences Centre
  • 12 South Street Hospital
  • 13 Hôtel-Dieu de Lévis
  • 14 Dalhousie University
  • 15 Centre Hospitalier Universitaire de Québec–Pavillon St. François d'Assise
  • 16 Jewish General Hospital
  • 17 University of Alberta
  • 18 Hôpital St. Sacrement
  • 19 McGill University Health Centre
  • 20 Sunnybrook Health Sciences Centre
  • 21 University of Toronto
  • 22 The Liver and Intestinal Research Centre
  • 23 Mount Sinai Hospital
Type
Published Article
Journal
Gastroenterology
Publisher
Elsevier
Publication Date
Jan 01, 2014
Accepted Date
Nov 18, 2013
Volume
146
Issue
3
Pages
681–688
Identifiers
DOI: 10.1053/j.gastro.2013.11.024
Source
Elsevier
Keywords
License
Unknown

Abstract

Background & AimsMethotrexate 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. MethodsIn 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. ResultsPatients' 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. ConclusionsThe 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.

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