Infliximab Therapy Improves Health Related Quality of Life in Ulcerative Colitis Patients

Abstract

Purpose: To examine the impact of infliximab (IFX) on health related quality of life (HRQL) in ulcerative colitis (UC) patients. Methods: 728 pts were enrolled in two trials: ACT 1 and 2. Pts were randomized (1:1:1) to placebo (PBO), IFX 5 mg/kg, or IFX 10 mg/kg. Treatment was administered at baseline, wks 2, 6, and then q8 wks. HRQL was assessed using the inflammatory bowel disease questionnaire (IBDQ) and the Short Form 36 questionnaire (SF-36). Analysis of variance on van der Waerden scores was used to compare the groups, on the pooled data from the trials. Results: Baseline IBDQ and SF-36 scores were similar among groups. The baseline mean total IBDQ score was 126. The baseline mean physical and mental component summary scores (PCS = 39 and MCS = 41) of the SF-36 were ∼1 standard deviation below the general U.S. population means (50), indicating impaired HRQL. At wk 8 and wk 30, the combined IFX group had greater improvements (p < 0.001, Table 1) from baseline in total IBDQ, PCS, and MCS scores vs PBO. All 4 IBDQ dimensions had improvements in the combined IFX group vs PBO (p < 0.001), at both time points. All 8 scales of the SF-36 showed improvement in the combined IFX group vs PBO at both timepoints, with significance (p < 0.05) in all but one scale at wk 30 (role-emotional, p = 0.081). There were no notable differences between the trials or the IFX groups.Table 1: Mean (Median) Improvements from Baseline in Total IBDQ, PCS, and MCS ScoresConclusions: IFX 5mg/kg or 10mg/kg results in substantially improved HRQL vs PBO, as measured by both disease specific and generic instruments.