HOME
Return to Table of Contents
DELAYED-RELEASE MESALAMINE SIGNIFICANTLY IMPROVED QUALITY OF LIFE IN PATIENTS WITH MILDLY AND MODERATELY ACTIVE ULCERATIVE COLITIS
EJ Irvine1, PDR Higgins, C-H Yeh
1St Michael’s Hospital/University of Toronto, Toronto, ON
BACKGROUND: Health-related quality of life (QoL) is vital to patients with chronic illnesses but has been rarely examined as an outcome in ulcerative colitis (UC) clinical trials. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a validated, reliable tool for measuring health-related QoL in patients with UC.
Purpose: To evaluate improvement in QoL by Asacol (mesalamine) delayed-release tablets in patients with mildly and moderately active UC.
METHODS: Data from 2 multi-center, randomized, double-blind, active-controlled trials of similar design (ASCEND I&II) were combined and analyzed. QoL was assessed using the IBDQ in 687 patients with mildly or moderately active UC treated for 6 weeks with delayed-release mesalamine 2.4g daily (400mg tablet) or 4.8g daily (800mg tablet). Treatment arms were pooled for the QoL analyses. The primary endpoint was overall improvement defined as improvement from baseline at week 6 in physician global assessment accompanied by improvement in at least one other clinical parameter (rectal bleeding, stool frequency, patient functional assessment, or sigmoidoscopy) and no worsening in any of the remaining clinical features.
RESULTS: The mean baseline IBDQ score was 143. Mean IBDQ total score and subscores improved significantly from baseline (ANOVA; p < 0.0001) at 3 weeks and 6 weeks (Table 1). Patients who met the primary endpoint of overall improvement at 6 weeks experienced a significantly greater mean QoL increase compared to patients with no improvement (p<0.0001, Figure 1).
Figure 1
CONCLUSION: Delayed-release mesalamine significantly improved QoL in patients with mildly and moderately active UC as early as 3 weeks. Patients who met the primary endpoint of overall improvement showed a greater improvement in QoL.
This research was funded by Procter & Gamble Pharmaceuticals
