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Asacol treats UC symptoms of isolated proctitis
Date:12/5/2007

fficacy 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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