Rapid Clinical Remission Is Significant for the Well-Being of Ulcerative Colitis Patients Treated with Delayed-Release Mesalamine

Abstract

Purpose: 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. The purpose of this analysis is 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: Combined data from two large multi-center, randomized, double-blind, active-controlled trials of similar design (ASCEND I & II) were analyzed for mildly and moderately active UC patients treated with Asacol (mesalamine) delayed-release tablets 2.4 g daily and who completed the IBDQ at 3 weeks after initiation of therapy (N = 274). Clinical remission was defined as patients achieving both 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 to therapy (those patients who achieved clinical remission at 3 weeks) were compared to the scores of Non-responders to therapy (those patients who did not achieve clinical remission at 3 weeks). Results: All domain scores (social, emotional, systemic, and bowel) for Responders were statistically significantly better relative to Non-responders at 3 weeks (Fig. 1). Additional improvement in the IBDQ scores for each domain is observed for the Responders at 6 weeks (P < 0.005).[figure1]FigureConclusion: 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.