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Impact of MMX mesalamine on improvement and maintenance of health-related quality of life in patients with ulcerative colitis
Inflammatory Bowel Disease, 06/22/2012
Clinical Article
Hodgkins P et al. – The sizeable burden of active mild–to–moderate Ulcerative colitis (UC) on health–related quality of life (HRQoL) was eliminated following 8 weeks' treatment with multimatrix (MMX) mesalamine 2.4–4.8 g/day. HRQoL remained stable over 12 months of maintenance treatment in patients with quiescent 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.
- 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.