BACKGROUND: Ulcerative colitis (UC) substantially reduces patients' health-related quality of life (HRQoL). The current study examined the burden of disease and the impact of daily multimatrix (MMX®) mesalamine treatment on HRQoL for patients with active or quiescent mild-to-moderate UC. METHODS: Data were from a two-phase, multicenter, open-label study with mild-to-moderate UC patients. In the acute phase, 132 patients with active disease received MMX mesalamine 2.4-4.8 g/day QD for 8 weeks. In the maintenance phase, 207 patients with quiescent disease received MMX mesalamine 2.4 g/day QD for 12 months. The Short Form-12 (version 2) (SF-12v2) measured HRQoL during each phase. Disease burden was examined by comparing acute-phase baseline scores with a U.S. general population sample. Repeated-measures analyses assessed change in SF-12v2 scores for each phase. Correspondence between HRQoL and disease activity was examined through correlations between SF-12v2 scores with patient-reported symptom measures. RESULTS: Baseline SF-12v2 scores for patients with UC were generally much lower than for the general population sample, indicating a broad disease burden. In the acute phase, significant improvement was observed for most SF-12v2 scores at week 8; a comparison with the matched norms showed a complete elimination of burden. No changes in SF-12v2 scores were observed during the maintenance phase. Changes in symptom measures and SF-12v2 scores were moderately correlated. CONCLUSIONS: The sizeable burden of active mild-to-moderate UC on HRQoL was eliminated following 8 weeks' treatment with MMX mesalamine 2.4-4.8 g/day. HRQoL remained stable over 12 months of maintenance treatment in patients with quiescent UC.
BACKGROUND:Ulcerative colitis (UC) substantially reduces patients' health-related quality of life (HRQoL). The current study examined the burden of disease and the impact of daily multimatrix (MMX®) mesalamine treatment on HRQoL for patients with active or quiescent mild-to-moderate UC. METHODS: Data were from a two-phase, multicenter, open-label study with mild-to-moderate UC patients. In the acute phase, 132 patients with active disease received MMX mesalamine 2.4-4.8 g/day QD for 8 weeks. In the maintenance phase, 207 patients with quiescent disease received MMX mesalamine 2.4 g/day QD for 12 months. The Short Form-12 (version 2) (SF-12v2) measured HRQoL during each phase. Disease burden was examined by comparing acute-phase baseline scores with a U.S. general population sample. Repeated-measures analyses assessed change in SF-12v2 scores for each phase. Correspondence between HRQoL and disease activity was examined through correlations between SF-12v2 scores with patient-reported symptom measures. RESULTS: Baseline SF-12v2 scores for patients with UC were generally much lower than for the general population sample, indicating a broad disease burden. In the acute phase, significant improvement was observed for most SF-12v2 scores at week 8; a comparison with the matched norms showed a complete elimination of burden. No changes in SF-12v2 scores were observed during the maintenance phase. Changes in symptom measures and SF-12v2 scores were moderately correlated. CONCLUSIONS: The sizeable burden of active mild-to-moderate UC on HRQoL was eliminated following 8 weeks' treatment with MMX mesalamine 2.4-4.8 g/day. HRQoL remained stable over 12 months of maintenance treatment in patients with quiescent UC.