Steroid Sparing Results in Further Improvement in Quality of Life in UC Patients in Remission

Abstract

Purpose: IFX has been shown to improve health related quality of life (HRQL) and achieve clinical remission while discontinuing steroids through 30 wks in pts with moderate-to-severe active UC. For pts in remission at wk 30, we compared the improvement in HRQL between those who discontinued steroid use, and those who had not. Methods: 728 pts were randomized (1:1:1) to PBO, IFX 5, or 10 mg/kg with tx at baseline, wks 2, 6, and q 8 wks (ACT 1 & ACT 2). HRQL was assessed using the IBDQ and SF-36. Pts on steroids at baseline and in remission at wk 30 were categorized into 2 grps: those who discontinued steroids at wk 30, and those who had not. Remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1. Analysis of variance on van der Waerden scores was used to compare change from baseline in HRQL scores. Results: Among 408 pts on steroids at baseline, 91 were in remission at wk 30. Of these 91 pts, 70 discontinued steroids at wk 30. Baseline scores of the IBDQ & physical and mental component summaries (PCS & MCS) of the SF-36 were similar between pts who discontinued steroids at wk 30 and those who had not. Pts who discontinued steroids at wk 30 had more improvement in the IBDQ and PCS vs those still on steroids. The difference was significant for PCS (Table).Table: Mean (median) baseline score & change from baseline in HRQL*Conclusions: Among pts in remission at wk 30, those who discontinued steroid use had more improvement in HRQL than those who had not. In the management of UC, steroid sparing, in addition to remission, should be an important goal in improving pts' HRQL.