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

2013; Elsevier BV; Volume: 146; Issue: 3 Linguagem: Inglês

10.1053/j.gastro.2013.11.024

1528-0012

Brian G. Feagan, John WD McDonald, Remo Panaccione, Robert Enns, Çharles N. Bernstein, Terry Ponich, Raymond Bourdages, Donald MacIntosh, Chrystian Dallaire, Albert Cohen, Richard N. Fedorak, Pierre Paré, Alain Bitton, Fred Saibil, Frank Anderson, Allan Donner, Cindy J. Wong, Guangyong Zou, Margaret K. Vandervoort, Marybeth Hopkins, Gordon R. Greenberg,

Microscopic Colitis

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. 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. 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. 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.