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IMPROVEMENT OF QUALITY OF LIFE IN PATIENTS WITH MODERATE ULCERATIVE COLITIS TREATED WITH DELAYED-RELEASE ORAL MESALAMINE 4.8G/DAY (800 MG TABLET)
E Irvine1, D Ramsey2, P Higgins31St. Michael's Hospital, Division of Gastroenterology, Toronto, Ontario; 2Procter and Gamble Pharmaceuticals, Inc., Mason, Ohio; 3University of Michigan, Department of Internal Medicine, Ann Arbor, Michigan, USA
Aims: Improvement in quality of life (QoL) in patients with ulcerative colitis (UC) experiencing a flare has important implications for overall patient satisfaction with treatment. The purpose of this analysis was to evaluate improvement in QoL in patients with moderately active UC recieving delayed-release mesalamine 4.8 g/day (Asacol® 800, 800 mg tablet).
Methods: Data were combined and analyzed from two randomized, double-blind, 6-week, active-control studies (ASCEND I and II) that compared the safety and efficacy of mesalamine 4.8 g/day (Asacol 800) to mesalamine 2.4 g/day (Asacol®, 400 mg tablet) in patients with mildly to moderately active UC. QoL was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ) at baseline, 3 and 6 weeks. The IBDQ is a validated, reliable tool for measuring health-related QoL in patients with UC. IBDQ scores range from 32 to 224 with a higher score corresponding to better QoL. Total IBDQ scores for patients in remission typically are >= 170. A study of UC patients suggested that an increase of >20 points in the IBDQ score was associated with patient defined significant improvement.
Results: A total of 687 patients were randomized in the two trials. 448 had moderately active UC (Physician's Global Assessment=2) and 213 recieved 4.8 g/day (Asacol 800). The mean baseline IBDQ score in patients recieving 4.8 g/day was 136. Treatment with 4.8 g/day produced a significant improvement in QoL at 3 and 6 weeks (Table). The mean change from baseline in the IBDQ score was 34 points at 3 weeks and 45 points at 6 weeks (p<0.0001 vs. baseline for both time points). In addition, all IBDQ subscores (bowel symptoms, systemic symptoms, emotional health, and social function) improved significantly from baseline at both 3 and 6 weeks, p<0.0001. The improvement from week 3 to week 6 also reached statistical significance in total and in all individual IBDQ domains (p<0.0001).
Conclusions: Treatment with delayed-release mesalamine 4.8 g/day (Asacol 800) significantly improved QoL in patients with moderately active UC as early as 3 weeks, with further improvement at 6 weeks.
Improvement in QoL in Moderately Active UC Patients Recieving 4.8 g/day (Asacol 800)
|% of patients with IBDQ Score = 170
|% of patients with >20 point increase in IBDQ score