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199 ENDOSCOPICALLY MEASURED MUCOSAL HEALING CORRELATED WITH RESPONSE TO THERAPY IN MODERATELY ACTIVE UC DT Rubin, B Yacyshyn, D Ramsey, GR Lichtenstein PURPOSE: To examine the correlation between endoscopically measured mucosal healing and response to therapy with delayed-release oral mesalamine 4.8 g/day (800 mg tab) and 2.4 g/day (400 mg tab) in patients with moderately active ulcerative UC.
University of Chicago Hospitals, Chicago, Illinios; Procter & Gamble Pharmaceuticals, Mason, Ohio; Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
METHODS: Data from 2 Phase III, multi-center, randomized, double-blind, 6-week, controlled studies of similar design (ASCEND I&II) were pooled and analyzed. The primary endpoint was treatment success, pre-defined as improvement from baseline in the Physician's Global Assessment (PGA) accompanied by improvement in at least one other clinical assessment (stool frequency, rectal bleeding, patient functional assessment (PFA), or endoscopy findings) and no worsening in any of the remaining clinical assessments. Mucosal healing was defined as an endoscopy score of 0 or 1. PFA was based on a 4-point scale from 0-3.
Patients with moderately active UC (baseline PGA=2) and baseline endoscopy subscore =>2 were included in this analysis. The correlation between mucosal healing and treatment response and PFA was determined.
RESULTS: 391 patients met the criteria for these analyses. The 2 treatment groups were balanced at baseline. Overall at 6 weeks, 67% of moderate UC patients who achieved treatment success also had mucosal healing (Kappa=0.6938). This finding was consistent regardless of daily dose. An endoscopic score of 0 alone was poorly correlated with treatment success but did improve from 3 weeks to 6 weeks (Kappa = 0.1176 and 0.2252, respectively). Regardless of dose or time, PFA correlated poorly with mucosal healing. Mesalamine was well tolerated with comparable adverse events reported in each of the two treatment groups.
CONCLUSION: Successful treatment of moderately active UC with mesalamine is associated with improved mucosal integrity as early as 3 and 6 weeks. However, there is a lack of association between endoscopic improvement and PFA.
This research was funded by Procter & Gamble Pharmaceuticals