Early and Sustained Efficacy of Delayed-Release Oral mesalamine in Moderately Active Ulcerative Colitis Patients

Abstract

Purpose: Early and sustained relief of the symptoms of ulcerative colitis (UC) is a key treatment goal in patients experiencing a flare. The purpose of this analysis was to determine if patients who respond to therapy at 3 weeks sustain the response at 6 weeks. Methods: Data from 3 multi-center, randomized, double-blind, active-controlled studies (ASCEND I, II, III) were combined and analyzed. Efficacy and safety of delayed-release mesalamine 4.8 g/day (investigational 800 mg tablet) was compared with 2.4 g/day (marketed Asacol® 400 mg tablet) in patients with moderately active UC (Physician's Global Assessment [PGA] = 2). The hallmark symptoms of UC, rectal bleeding and stool frequency, were evaluated. Improvement in rectal bleeding and stool frequency was defined as a decrease from baseline of at least 1 point based on a 4 point scale (0–3). Clinical remission was defined as resolution (score = 0) of both rectal bleeding and stool frequency. Results: A total of 1220 patients with moderately active UC were randomized and dosed. The Table below reviews treatment outcome results in patients with moderately active UC at 3 and 6 weeks and reports the percent of patients who had a response at 3 weeks with a continued response at 6 weeks. A high percentage of patients who had a response at 3 weeks also had a response at 6 weeks.TableConclusion: Results from this large combined analysis showed that delayed-release oral mesalamine provided early (in as few as 3 weeks) and sustained efficacy in patients with moderately active UC.