Reducing the Incidence of Bowel Surgeries in Ulcerative Colitis Patients

A new study has shown that Remicade (infliximab) significantly reduces the incidence of colectomy surgeries for patients with moderately to severely active ulcerative colitis (UC).

Researchers at the University Hospital Gasthuisberg (Leuven, Belgium) conducted an analysis of long-term extension data of the Active Ulcerative Colitis (ACT) 1 and 2 trials that included 728 patients from the initial ACT 1 and 2 trials, of whom 86% percent had complete follow-up through 54 weeks to ascertain whether they underwent colectomy--the surgical removal of the colon--surgery. During the extension trial, the patients continued to receive the study drug to which they were originally randomized (Remicade or placebo) every eight weeks. Patients in the extension trials were assessed using the Physician's Global Assessment (PGA), which is one of four measures of disease activity included in the Mayo score.

The study results showed that there was a 43% reduction in the incidence of colectomy in patients receiving Remicade through 54 weeks, compared to those receiving placebo. Remicade was generally well tolerated in the long-term extensions, with less than five percent of patients discontinuing therapy due to an adverse event (AE), which included: prostate cancer, breast cancer, pneumonia, sarcoidosis, abscess and a death following Histoplasmosis pneumonia. The study was presented at the annual meeting of the American College of Gastroenterology (ACG) held during October 2007 in Philadelphia (PA, USA).

"These data illustrate that treatment with Remicade significantly reduces the need for life-altering colectomy in patients with refractory ulcerative colitis,” said lead author Paul Rutgeerts, M.D., Ph.D., "Remicade may offer patients who fail other therapies the possibility of avoiding costly surgeries and hospitalizations while managing the symptoms of this debilitating disease long-term.”

Remicade (infliximab) is an anti-tumor necrosis factor alpha (TNF-alpha) therapy and is so far the first and only biologic approved for the treatment of ulcerative colitis. Remicade is made by Centocor (Leiden, The Netherlands).


Related Links:
University Hospital Gasthuisberg
Centocor