Response and Remission Are Associated with Improved Quality of Life in Patients with Ulcerative Colitis: 791

Purpose: Data from ACT 1 & 2 (randomized, controlled trials of infliximab) were used to examine the relationship between health-related quality of life (HRQL) and response and remission. Methods: Based on wk 30 actual Mayo scores, 728 pts were categorized as non-responders, responders (those in response but not in remission), or remission. Response was defined as a decrease from baseline in Mayo score by ≥30% and ≥ 3 points, with a decrease in rectal bleeding subscore of ≥1 or rectal bleeding subscore of 0 or 1. Remission was defined as a Mayo score ≤2 points, with no individual subscore >1. HRQL was assessed using the IBDQ and the SF-36. Analysis of variance was used to compare IBDQ and SF-36 changes from baseline to wk 30 among groups. Results: At baseline the physical and mental component summary scores (PCS = 38 and MCS = 40) of the SF-36 were ∼ 1 standard deviation below the general U.S. population means of 50, indicating impaired HRQL. The mean baseline total IBDQ score was 126.5. At wk 30, pts in remission had the greatest increases from baseline in total IBDQ, PCS, and MCS. Changes for responders were smaller than those for pts in remission, but were greater than non-responders. All comparisons of the responder and remission groups vs the non-responder group were significant (p < 0.001, Table 1). Mean PCS (50.4) and MCS (51.8) for pts in remission at wk 30 were similar to the general U.S. population means.Table 1: Wk 30 Mean Total IBDQ, PCS, and MCS Scores and Change from BaselineNote: A 16 point change in IBDQ score or 2.5 point change in SF-36 PCS or MCS is considered clinically meaningful. Conclusions: Pts who achieved remission/response had significantly greater improvements in HRQL than non-responders. Pts in remission had HRQL scores similar to the general U.S. population.