Rx Combo for Crohn's No Better Than Rx Alone

Crohns disease treatment with methotrexate plus infliximab no more effective than infliximab alone

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Medications can treat symptoms of Crohn’s disease, but the disease often remains active. Researchers recently studied whether a combination of medications might work better than one by itself.

Crohn’s disease is a painful inflammatory bowel disease that can occur anywhere along the gastrointestinal tract. Decreasing the activity of the disease (creating disease remission) is the goal of treatment, but treatments miss this mark in up to 40 percent of Crohn's patients.

Medications such as methotrexate and biologic antibodies like infliximab (brand name Remicade) are used to calm the overactive immune system in Crohn’s. Medical researchers have tested combinations of medications to see if they are more effective than single medications.

A recently published study found that treatment with both methotrexate and infliximab was not more effective than infliximab alone to bring Crohn’s disease into remission.

"Ask your gastroenterologist for Crohn’s disease treatment options."

Brian G. Feagan, MD, from the Departments of Medicine and Epidemiology and Biostatistics at Western University in London, Ontario, Canada, led the research team who conducted this study.

A total of 126 patients with Crohn’s disease who started taking prednisone within the previous six weeks were recruited into the study. The average age range of these patients was 38 to 40. Many Crohn's patients are prescribed prednisone to decrease inflammation in the gastrointestinal tract and symptoms associated with the inflammation.

Patients were divided into two groups of 63 patients each. One group received a weekly dose of 10 mg of methotrexate that increased to 25 mg per week. The other group received a placebo (fake medication). Patients in each group were given an infusion of infliximab at weeks 1, 3, 7 and 14 and every eight weeks after that.

The study went on for 50 weeks, during which time the research team evaluated the activity of the Crohn’s disease to see if the treatment eliminated the need for anti-inflammatory treatment with prednisone. Prednisone-free remission was one of the goals of the study treatments.

Another goal of the study was to evaluate the safety of the treatments. This was assessed by the number and types of adverse events experienced by the study participants.

At the 14-week point in the study, both groups had a similar prednisone-free remission rate — 76 percent of the group taking the medication combination and 78 percent of the group taking infliximab only.

The researchers did not find a difference in prednisone-free remission between the two groups by week 50 of the study. Both the infliximab group and the group taking infliximab and methotrexate had about a 30 percent failure rate, meaning 30 percent did not achieve a prednisone-free remission.

Adverse events were also similar between the two groups. A common adverse event was worsening of Crohn’s disease, experienced by 33 percent of the combination treatment group and 30 percent of the infliximab only group. Nausea, vomiting or abdominal pain was reported by about 40 to 48 percent of each group.

Dr. Feagan and team noted some limitations of their study, including that treatment with prednisone alone was not studied and that repeat colonoscopies were not done to determine Crohn’s disease activity.

The authors summarized their results by saying that, in Crohn's patients needing a corticosteroid like prednisone, the combination of methotrexate and infliximab was not more effective than infliximab alone.

"Medications used to treat inflammatory autoimmune disorders have a long list of serious side effects, including Black Box Warnings," said Steve Leuck, PharmD, president and owner of AudibleRx. "Regardless of the treatment regimen, any and all patients prescribed medications in this category of disease modifying or immunosuppresive medications need to spend time consulting with their community pharmacist so they have a clear idea of what to expect and what to look out for while taking their medication regimen."

This study was published in the March issue of Gastroenterology.

Funding for the study was provided by the Crohn’s and Colitis Foundation of American, Merck/Schering-Plough Canada and Prometheus Laboratories, Inc.

Dr. Feagan disclosed receiving support and/or consulting fees from numerous organizations, including Prometheus Therapeutics and Diagnostics and Janssen-Ortho, part of Janssen Pharmaceutical Company, manufacturers of Remicade. He also disclosed serving as a member of the speakers bureau for Janssen.

Review Date: 
March 4, 2014
Last Updated:
March 6, 2014