期刊
INFLAMMATORY BOWEL DISEASES
卷 18, 期 6, 页码 1026-1033出版社
WILEY-BLACKWELL
DOI: 10.1002/ibd.21841
关键词
MMX mesalamine; ulcerative colitis; 5-aminosalicylic acid
资金
- Shire Pharmaceuticals Inc.
- Shire Pharmaceuticals, Wayne, PA
- Shire
- Warner Chilcott
- Elan
- Abbott
- BMS
- Centocor
- Forest
- GSK
- Hutchinson
- Millennium
- Pfizer
- Prometheus
- Quest
- UCB
- Salix
- Evoke
- Axcan
- Tranzyme
- Proctor and Gamble
- AstraZeneca
- Takeda
Background: This was a phase IV, multicenter, open-label, 1214-month study to assess clinical recurrence in patients with ulcerative colitis (UC) who received maintenance treatment with MMX Multi Matrix System (MMX) mesalamine. A secondary outcome was the relationship between long-term efficacy and adherence. Methods: Patients with quiescent UC (no rectal bleeding; 01 bowel movements more than normal per day) were enrolled directly into a 12-month maintenance phase of the study during which they received MMX mesalamine 2.4 g/day given once daily (QD). Patients with active, mild-to-moderate UC at screening were enrolled into a 2-month acute phase; those who achieved quiescence could continue into the maintenance phase. The primary endpoint was clinical recurrence at Month 6. Results: Of the 290 patients enrolled, 208 entered the maintenance phase; 152 directly and 56 via the acute phase. Following 6 and 12 months of treatment, 76.5% and 64.4% of evaluable patients, respectively, were recurrence-free. The majority of evaluable patients at Month 6 (81.6%) and Month 12 (79.4%) in the maintenance phase were =80% adherent to MMX mesalamine. At Month 6, clinical recurrence was observed in 20.6% of patients who were =80% adherent and 36.1% of patients with <80% adherence (P = 0.05 [post-hoc chi-square analysis]); 31.2% and 52.5% at Month 12 (P = 0.01 [post-hoc chi-square analysis]). Conclusions: MMX mesalamine 2.4 g/day QD is effective for maintaining quiescence in patients with UC. Furthermore, adherence to prescribed treatment yielded lower rates of clinical recurrence. Continued education regarding the importance of long-term 5-aminosalicylic acid therapy is warranted. (Inflamm Bowel Dis 2012;)
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