Impact of MMX® mesalamine on improvement and maintenance of health-related quality of life in patients with ulcerative colitis
Article first published online: 30 MAY 2012
Copyright © 2012 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
How to Cite
Hodgkins, P., Yen, L., Yarlas, A., Karlstadt, R., Solomon, D. and Kane, S. (2012), Impact of MMX® mesalamine on improvement and maintenance of health-related quality of life in patients with ulcerative colitis. Inflamm Bowel Dis. doi: 10.1002/ibd.23022
- Article first published online: 30 MAY 2012
- Manuscript Accepted: 25 APR 2012
- Manuscript Received: 22 MAR 2012
- The study, data analysis, and article preparation was funded in full by Shire Development LLC
- MMX mesalamine;
- ulcerative colitis;
- health-related quality of life;
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.
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.
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.
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. (Inflamm Bowel Dis 2012;)