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RAPID CLINICAL REMISSION IS SIGNIFICANT FOR THE WELL-BEING OF ULCERATIVE COLITIS PATIENTS TREATED WITH DELAYED-RELEASE MESALAMINE
EJ Irvine1, S Magowan, M Pasquale, S Katz
1St Michael’s Hospital/University of Toronto, Toronto, Ontario
BACKGROUND: Rapid improvement in bowel symptoms is a key treatment goal for ulcerative colitis patients experiencing a flare, and has important implications for overall patient satisfaction with treatment. However, there is a paucity of data reporting quality of life benefits for the patient achieving rapid clinical remission.
Objective: To quantify the improvement in social, emotional, systemic, and bowel domains associated with clinical remission at 3 weeks using the Inflammatory Bowel Disease Questionnaire (IBDQ).
METHODS: Pooled data from two large multi-center, randomized, double-blind, active-controlled trials of similar design (ASCEND I & II) were analyzed for mild and moderately active UC patients treated with Asacol 2.4g daily (400mg tablet) and who completed the IBDQ at 3 weeks after initiation of therapy (n=274). Clinical remission was defined as patients achieving a rectal bleeding score = 0 and a stool frequency score = 0 at 3 weeks. The change in IBDQ scores from baseline to 3 weeks for Responders (those patients who achieved clinical remission at 3 weeks) were compared to the scores of Non-responders (those patients who did not achieve clinical remission at 3 weeks).
RESULTS: At 3 weeks, the IBDQ total score improved by 24% for Responders receiving Asacol 2.4g/day compared with 18% for Non-responders (p=0.0024). The change from baseline for Responders was significantly greater than that for Non-responders within the emotional and bowel domains (p<0.05). Improvement was also noted in social and systemic domains (p values = 0.068 and 0.059, respectively) (Figure 1). For Responders, additional improvement in the IBDQ scores for each domain is observed at 6 weeks.
CONCLUSION: These results indicate that an early time to clinical remission is significantly associated with improvement in patient well-being, as measured by changes in IBDQ scores.
This research was funded by Procter & Gamble Pharmaceuticals.
