Aventura, Fl., December 5, 2007 Data from two Phase III clinical trials support that Asacol, an oral, non-steroidal medication that belongs to the class of agents known as 5-aminosalicylic acids (5-ASAs), is an effective and well-tolerated treatment for patients with all extents of ulcerative colitis (UC), including isolated proctitis. The results showed that patients with isolated proctitis who took Asacol, dosed at 2.4 g/day for six weeks, experienced significant improvement as early as three weeks, and sustained improvement at six weeks, of UC symptoms. At six weeks 83 percent of patients had improvement in rectal bleeding, 75 percent had mucosal healing and 57 percent had reduced stool frequency. These data were presented today at the Crohns & Colitis Foundation of Americas (CCFA) National Research and Clinical Conference/Sixth Annual Advances in the Inflammatory Bowel Diseases (IBD) Meeting.
Treatment of UC patients is impacted by the fact that most patients would choose oral therapy over other routes of delivery, such as rectal therapy. However, approximately 30 percent of UC patients have isolated proctitis , a condition that is thought to be a challenge to treat with oral medication alone.
A common misperception among physicians is that all oral 5-ASA studies have included proctitis patients; however, this is not the case, says Dr. Seymour Katz, Clinical Professor of Medicine at the New York University School of Medicine. The positive findings from these Asacol studies reassure physicians that Asacol is one treatment that has been proven effective throughout the entire colon, even the most distal portions, and should help guide physicians how to effectively treat their UC patients.
Additional Study Details
Data from two Phase III, multi-center, randomized, double-blind, 6-week, active-controlled studies of similar design (ASCEND I&II) were combined and analyzed. The aim of this analysis was to evaluate the efficacy of oral delayed-release Asacol dosed at 2.4 g/day to treat active UC flares in patients with isolated proctitis.
This analysis included data from the Asacol 2.4 g/day active control arms of these two studies. Of the 349 patients who received Asacol 2.4 g/day, 63 had isolated proctitis, 205 had left-sided disease (proctosigmoiditis and left-sided colitis) and 81 had pancolitis. To be included in the studies, patients had to have mildly to moderately active UC and a baseline score in either or both the rectal bleeding and stool frequency clinical assessments of at least 1 (based on 4-point scale, 0-3). Patients were prohibited from taking rectal therapies and were only treated with Asacol. Clinical analyses included improvement in rectal bleeding and stool frequency defined as a decrease from baseline of at least 1 point/grade. Mucosal healing was also evaluated in patients who had a baseline endoscopy subscore of 2 or greater. Mucosal healing was defined as an endoscopy subscore of 0 or 1.
After six weeks, 76 percent of patients in both the left-sided disease and pancolitis groups experienced an improvement in rectal bleeding. Additionally, 74 percent of patients with left-sided disease experienced an improvement in stool frequency and 70 percent achieved mucosal healing. Of the patients with pancolitis, 70 percent had improvement of stool frequency and 71 percent experienced mucosal healing. Asacol 2.4 g/day was well-tolerated, with adverse events and laboratory findings consistent with those described in previous trials and the current prescribing information.
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