March 2001

From Mayo Clinic

Mayo Clinic study finds infliximab ‘safe and beneficial’ for Crohn’s disease

Rochester, MN -- A new drug for treating Crohn’s disease (CD), is safe and beneficial for patients who have not gotten relief from other medications, according to findings of a Mayo Clinic study published in the March issue of the American Journal of Gastroenterology. Of the first 100 Mayo Clinic patients to receive infliximab (Remicade, Centocor, Inc.), infusions, 72 experienced a positive response.

"Many of these patients have now received several infusions, and have done quite well for up to two years," says William J. Sandborn, M.D., a Mayo Clinic gastroenterologist and the lead investigator for the study. "These results are encouraging, because they confirm in clinical practice the promise that infliximab has offered to some very sick people for whom we have had no other good options."

Affecting about 400,000 people in North America, CD is an inflammation in the gastrointestinal tract that can spread across the entire wall of the large and small bowel. Symptoms include diarrhea, fever, abdominal pain and weight loss. About 30 percent of patients develop fistulas, openings in the bowel wall which cause bowel contents to leak into nearby organs or even to the surface of the skin. As many as 20 percent or more of CD sufferers do not respond to standard treatments, which include steroids, immunosupressant medications and surgery.

"The carefully controlled clinical trials that lead to Food and Drug Administration approval usually exclude patients with the most severe cases, and the duration of follow-up is often relatively short," says Dr. Sandborn. "As a result, the experience in actual clinical practice when a drug becomes available for wider use can be disappointing. Our study was aimed at evaluating the real-world response to infliximab in a larger group of patients, including those with severe symptoms, and following them for at least three months to determine longer term benefit."

The 40 males and 60 females, ages 15 to 77 years, who participated in the Mayo Clinic study showed signs of inflammatory disease (61 patients), fistulizing disease (26 patients), or both (13 patients). Infliximab infusions were administered to each based on the treatment indication, the clinical response and the preferences of each treating physician. All were monitored for adverse reactions during and after each infusion.

A positive response was observed in 72 percent of patients treated for inflammatory symptoms alone, in 65 percent of those with fistulas, and in 84.5 percent of patients treated for both inflammation and fistulizing disease. Of the 40 patients who had been receiving steroid treatments, nearly three-fourths were able to discontinue steroid use. The overall clinical response lasted for ten weeks, which would be consistent with a real treatment benefit.

Infliximab was generally well tolerated, although a few infusion-related reactions were seen, including non-cardiac chest pain (six patients), shortness of breath (six patients), fever (three patients), flu-like symptoms (three patients) and myalgias (three patients).

The FDA approved infliximab in August 1998 for short-term treatment of moderate to severe cases of CD among patients who have inadequate response to conventional therapy. Infliximab’s function is to act as an agent to block the activity of a key inflammatory mediator called tumor necrosis factor alpha (TNF-alpha), thus reducing inflammation in CD patients by binding to and neutralizing TNF-alpha on the cell membrane and in blood.

Partial funding for the study was provided by Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, a worldwide manufacturer of health care products.

Video Feed: A video feed, including sound bites from the study’s principal investigator, a patient interview and b-roll will be fed via satellite at 3 p.m. CST on Tues., March 13, 2001.




This article comes from Science Blog. Copyright © 2004
http://www.scienceblog.com/community

Archives 2001 B