By Ed Susman
SAN DIEGO -- May 21, 2008 -- Researchers found no advantage to adding methotrexate to the treatment of patients with Crohn's disease who were on infliximab therapy, according to a presentation here at Digestive Diseases Week 2008 (DDW).
Brian G. Feagan, MD, Director, Robarts Research Institute, and Professor of Medicine and Professor of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada, presented the results in an oral, late-breaking presentation on May 20.
The study was conducted to compare the efficacy and safety of infliximab plus methotrexate versus infliximab monotherapy in patients with Crohn's disease receiving prednisone induction therapy.
The researchers assessed the effect of treatment on disease activity, quality of life, safety, and tolerability, Dr. Feagan said.
Patients were treated with either the methotrexate plus infliximab or infliximab alone. Patients were also on prednisone therapy at the start of the study, but the dose was tapered gradually so that at 14 weeks the use of the corticosteroid was discontinued in both arms.
Patients in the study were about 40 years of age, a slight majority of patients were men; the initial Crohn's Disease Activity Index (CDAI) score was 207.
The study's primary endpoint was clinical remission, defined as a score of 150 or less in the CDAI score at 14 weeks, and no relapse through week 50, Dr. Feagan said.
After 14 weeks, 77.8% of 63 patients on infliximab alone had achieved remission compared with 76.2% of 63 patients on the infliximab-methotrexate combination (P = .83).
After 50 weeks, 57.1% of the group on infliximab monotherapy and 55.6% of those on the combination remained in remission without having to return to corticosteroid support and maintained remission status (P = .86), Dr. Feagan said.
Dr. Feagan and colleagues also found no statistically significant differences in outcomes when they assessed patients according to Crohn's disease duration (<2 years or >12 years), C-reactive protein level, or mean CDAI scores.
However, the group of patients that received infliximab monotherapy had numerically lower CDAI scores compared with the combination arm, but the difference did not reach statistical significance (P = .09). There was no difference between treatment arms in terms of quality of life variables.
Similarly, the researchers observed no differences in tolerability or safety between treatment arms and infection rates were similar with 2 treatments.
"We saw a high degree of success for both treatment arms," Dr. Feagan said. "But triple induction therapy -- methotrexate, prednisone, and infliximab followed by methotrexate-infliximab maintenance -- was not more effective than dual induction therapy with prednisone and infliximab followed by infliximab monotherapy."
The trial was an investigator-initiated study.
[Presentation title: A Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Infliximab in Combination With Methotrexate for the Long-Term Treatment of Crohn's Disease. Late breaker Abstract 862c]
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