Drug Benefits Patients With Crohn’s Disease

(Ivanhoe Newswire) -- A new study shows a drug to treat Crohn’s disease can help prevent a common complication. Fistulas are openings from affected areas of the intestine into other organs or onto the skin. Fistulas can seriously impact a person’s lifestyle and increases the need for surgery. The new research shows giving patients the drug infliximab every eight weeks can prevent or delay the recurrence of fistulas.

“Fistulas can be a devastating complication of Crohn’s disease,” says Bruce Sands, M.D., of the Massachusetts General Hospital Gastrointestinal Unit and lead author of the study. “While neither medical nor surgical therapy is perfect in treating this complication, our study has shown that maintenance treatment with infliximab can produce durable closure of fistulas in many patients.”

The study included 300 patients from 45 sites in North America, Europe and Israel. All of the patients received three intravenous doses of infliximab over six weeks. The patients were then evaluated several weeks later to see who responded to the treatment. After that evaluation, the patients were assigned to receive infliximab doses every eight weeks or a placebo. Neither the patients nor the researchers knew to which group each patient was assigned.

Researchers report, among the patients who initially showed a response to the drug, fistulas recurred much less frequently among those receiving treatment than in the placebo group. At the end of the 54-week study, almost half of those receiving infliximab still showed some response, with more than one-third remaining free of fistulas. Specifically, 19 percent of the patients in the placebo group were fistula-free compared to 36 percent of the patients on the maintenance dose of infliximab.

Study authors also report continuing the treatment instead of waiting for symptoms seems to be superior as well. Patients in the placebo group who developed fistulas were given an opportunity to have the drug. Researchers say although many experienced a response on the drug, they all had to deal with worsening symptoms. Researchers caution patients on infliximab for extended periods of time also need to be watched closely for infections. They say infliximab does suppress some of the immune response. However, researchers point out that besides the improvement of fistulas, for patients who respond to treatment, this drug appears to help improve their quality of life.

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SOURCE: New England Journal of Medicine, 2004;350:876-885