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Study shows drug can heal, reduce recurrence of fistulas in Crohn's disease

over six weeks. They were evaluated several weeks later to determine whether they responded to the infliximab treatment defined as a 50 percent or greater reduction in the number of draining fistulas and subsequently randomized into groups receiving either continuing infliximab doses every eight weeks or placebo infusions. Neither participants nor the researchers knew to which groups patients were assigned.

Among participants who initially showed a response to infliximab, fistulas recurred much less frequently among those receiving continuing treatment than in the placebo group. At the end of the 54-week study, almost half those receiving infliximab still showed some response, with more than one-third remaining free of fistulas. Less than 20 percent of the placebo group stayed fistula-free during the same time period.

"The benefits of infliximab in this patient population go beyond closing of fistulas," Sands explains. "These patients also have a reduction in other symptoms and demonstrable improvement in their quality of life. While infliximab is not effective for all patients, the impact can be remarkable for those who do respond." Sands is an assistant professor of Medicine at Harvard Medical School.

The researchers also note that continuing treatment at fixed intervals appears superior to waiting until symptoms recur to reinstate therapy. Patients in the placebo group who redeveloped fistulas during the study could resume infliximab treatment, but although many experienced a renewed response to the medication, they all had to deal with worsening symptoms. Since infliximab does suppress part of the immune response, patients on sustained therapy should be followed closely for evidence of infection or other serious side effects.

Additional authors of the NEJM paper include senior author Sander van Deventer, MD, PhD, of Academisch Medisch Centrum, Amsterdam; Frank Anderson, MD, Vancouver Hospital; Charles Bernstein, MD,
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Contact: Sue McGreevey
smcgreevey@partners.org
617-724-2764
Massachusetts General Hospital
25-Feb-2004


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