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P187. Examining the time to clinical recurrence with long-term MMX® mesalazine maintenance therapy in patients with quiescent ulcerative colitis

P187. Examining the time to clinical recurrence with long-term MMX® mesalazine maintenance therapy in patients with quiescent ulcerative colitis

S. Kane1, D. Solomon2, M. Palmen3, K. Barrett3

1Mayo Clinic, Rochester, MN, United States; 2Shire Pharmaceuticals Inc., Wayne, PA, United States; 3Shire Pharmaceuticals Inc., Basingstoke, United Kingdom

Aims: Active ulcerative colitis (UC) can result in unpleasant and frequently distressing symptoms and patients often require long-term treatment to maintain disease quiescence. Therefore, when beginning a new treatment regimen, the duration that patients' disease is likely to remain quiescent is an important consideration for both patients and physicians. In this analysis, we examine results from a long-term phase IV study, of patients with quiescent UC who received maintenance treatment with MMX® mesalazine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Ltd., Ireland), and determined the time to clinical recurrence.

Methods: The SIMPLE (Strategies in Maintenance for Patients Receiving Long-term Therapy) study was a phase IV, multicentre, open-label trial conducted in 51 centres in the USA. In the study's maintenance phase, patients with quiescent UC received MMX mesalazine 2.4 g/day once daily (QD) for 12 months. Quiescent UC was defined as no rectal bleeding and 0–1 more bowel movements than normal per day, (either at enrolment or following 8 weeks' acute treatment with MMX mesalazine [2.4–4.8 g/day; acute phase]). We examined clinical recurrence (defined as four or more bowel movements per day above the patient's normal frequency and associated with urgency, abdominal pain or rectal bleeding) at 6 and 12 months.

Results: In total, 208 patients entered into the 12-month maintenance phase and 207 were included in the maintenance phase efficacy population. At 12 months, 64% of patients remained recurrence free. Examination of patient outcomes according to predefined patient and disease characteristics did not identify any significant differences.

Figure. Time to clinical recurrence: maintenance phase efficacy population.

Conclusions: Over 60% of patients did not experience disease recurrence during this study. The time from beginning treatment until disease recurrence was unaffected by whether patients achieved disease quiescence prior to receiving MMX mesalazine therapy, or if they first required acute induction therapy with MMX mesalazine.

This study was funded by Shire Pharmaceuticals Inc.