PHILADELPHIA, PA, October 15, 2007- Clinical data presented today at the annual meeting of the American College of Gastroenterology (ACG) show that REMICADE significantly reduces the incidence of colectomy surgeries for patients with moderately to severely active ulcerative colitis (UC). According to a primary analysis of long-term extension data from the Active Ulcerative Colitis 1 and 2 trials (ACT trials), there is a 41 percent reduction in the incidence of colectomy, the surgical removal of the colon, in patients receiving REMICADE through 54 weeks, compared to those receiving placebo (p=0.015). REMICADE is the first and only biologic approved for the treatment of ulcerative colitis.
The analysis of the ACT extension trials included 728 patients from the initial ACT 1 and 2 trials, of whom 630 (86 percent) had complete follow-up through 54 weeks to ascertain whether they underwent colectomy surgery.
"These data illustrate that treatment with REMICADE significantly reduces the need for life-altering colectomy in patients with refractory ulcerative colitis," said Paul Rutgeerts, M.D., Ph.D., University Hospital Gasthuisberg, University of Leuven; Leuven, Belgium. "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."
Separate data also presented at ACG today show the significant impact of colectomy on ulcerative colitis patients' use of healthcare services, including inpatient and outpatient hospital procedures, emergency room and physician visits, and laboratory and drug costs. A retrospective analysis of 411 patients, identified from the U.S. PharMetrics database as having UC and a colectomy between January 1, 2000, and June 30, 2005, found that total utilization of healthcare services increased significantly in the 12 months following colectomy, including inpatient and outpatient procedures (P
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