Rapid Symptom Resolution with Delayed Release Mesalamine in Mildly and Moderately Active UC

Abstract

Purpose: To evaluate time to clinical remission in patients with mild and moderate active UC receiving 2.4 g/d of Asacol (mesalamine) delayed-release tablets. Methods: Data from 2 multi-center, randomized, double-blind, active-controlled, 6-wk studies of similar design (ASCEND I&II) were combined and analyzed. The studies included patients with mild (PGA = 1) and moderate (PGA = 2) active UC. This analysis includes data from the 2.4 g/d active control arms of these studies. Clinical remission was defined as resolution (score = 0) of both rectal bleeding (RB) and stool frequency (SF). Resolution of RB was defined as the absence of visible blood in stools and resolution of SF was defined as a patient's return to his/her normal number of stools/day. To be included in analysis patients had to have symptoms at baseline. Time to clinical remission was defined as the first day of 3 consecutive days of complete symptom resolution based on symptoms recorded by patients daily through an integrated voice response system (IVRS). Results: 687 patients were randomized in the 2 studies, of which 349 received 2.4 g/d. Based on IVRS data, the median time to clinical remission in patients with mild and moderate active UC was 26 days (95% CI 24,33). Time to clinical remission by disease severity is shown below:[figure1]In addition, results of the time to complete resolution analysis by individual symptoms and disease severity are shown below:FigureTableAsacol 2.4 g/d was well-tolerated, with adverse events consistent with those described in the current prescribing information. In pivotal clinical studies of active UC, the most frequent adverse events reported for Asacol were headache, abdominal pain, and eructation. Conclusion: In active UC, rapid symptom relief is a key treatment goal. Asacol 2.4 g/d provided rapid symptom relief in patients with mild and moderate active UC.