Methotrexate and infliximab are effective therapies for Crohn's disease (CD).
In the combination of maintenance methotrexate-infliximab trial, Dr Brian Feagan and colleagues from Canada evaluated the potential superiority of combination therapy over infliximab alone.
In a 50-week, double-blind, placebo-controlled trial, the team compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy 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, or placebo.
Both groups received infliximab at weeks 1, 3, 7, and 14, and every 8 weeks thereafter.
|The actuarial rate of treatment failure was 31% in the combination therapy group|
Prednisone was tapered, beginning at week 1, and discontinued no later than week 14.
The research team's primary outcome was time to treatment failure, defined as a lack of prednisone-free remission at week 14 or failure to maintain remission through week 50.
Patients' baseline characteristics were similar between groups.
By week 50, the actuarial rate of treatment failure was 31% in the combination therapy group compared with about 30% in the infliximab monotherapy group.
Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein.
The team observed no clinically meaningful differences were observed in secondary outcomes.
The research team found that combination therapy was well tolerated.
Dr Feagan's team concludes, "The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone."