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200 ENDOSCOPICALLY MEASURED MUCOSAL HEALING OF DELAYED-RELEASE ORAL MESALAMINE 4.8 g/DAY VERSUS 2.4 g/DAY GR Lichtenstein, D Rubin, R Eusebio PURPOSE: To determine the effect of delayed-release oral mesalamine 4.8 g/day (investigational 800 mg tablet) vs 2.4 g/day (marketed 400 mg tablet) on endoscopically measured mucosal healing in patients with moderately active ulcerative colitis (UC).
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Chicago, Chicago, Illinois; Procter & Gamble Pharmaceuticals, Mason, Ohio, USA
METHODS: Data from two Phase III, multi-center, randomized, double-blind, 6-week, controlled studies of similar design (ASCEND I&II) were pooled and analyzed. Mucosal healing was defined as endoscopy subscore of 0 or 1. Patients with moderately active UC (defined as a baseline Physician's Global Assessment score of 2) and baseline endoscopy subscore => 2 were included in this analysis.
RESULTS: A total of 423 analyzable patients with moderate UC were randomized in the two studies, of which 391 patients met criteria for this analysis. The two treatment groups were balanced with regard to baseline and demographic characteristics, disease history, and baseline disease state characteristics. In the population of patients with moderately active UC and baseline endoscopy subscore => 2, the percentage of patients achieving mucosal healing is shown in the table below.
| Mucosal Healing in Moderate UC Patients | ||
| 2.4 g/day n=209 | 4.8 g/day n=182 | |
| Week 3 | 58% | 65% |
| Week 6 | 68% | 80%* |
| *p<0.05 | ||