Long-term Maintenance Treatment with MMX® Mesalamine in Patients with Quiescent Ulcerative Colitis: Time to Clinical Recurrence

Abstract

Purpose: Patients with ulcerative colitis (UC) often require life-long treatment to maintain disease quiescence. When starting a new course of maintenance treatment for quiescent UC, the length of time that patients are likely to remain recurrence free is an important consideration for both patients and physicians. In this analysis of a phase IV study, we evaluated the time to clinical recurrence in patients receiving maintenance treatment with MMX® mesalamine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Ltd., Ireland). Methods: The Strategies in Maintenance for Patients Receiving Long-term Therapy (SIMPLE) study was a phase IV, multicenter, open-label trial conducted in 51 centers across the USA. Patients with quiescent UC (defined as no rectal bleeding and 0-1 more bowel movements than normal per day, either at enrollment or following 8 weeks' treatment with MMX mesalamine [2.4-4.8 g/day; acute phase]) received MMX mesalamine 2.4 g/day once daily (QD) for 12 months (maintenance phase). We examined clinical recurrence at 6 and 12 months. Clinical recurrence was defined as four or more bowel movements per day above the patient's normal frequency and associated with urgency, abdominal pain or rectal bleeding. Results: In total, 208 patients were enrolled to the 12-month maintenance phase, and 207 were included in the maintenance phase efficacy population. Overall, 64% of patients remained recurrence free by 12 months. Examination of patient outcomes according to some predefined patient and disease characteristics did not identify any significant differences. Conclusion: A low proportion of patients experienced disease recurrence during the study and the time to recurrence was similar regardless of whether patients had achieved disease quiescence prior to receiving MMX mesalamine therapy, or if they first required acute induction therapy with MMX mesalamine. Disclosure: Sunanda Kane - Research funding received from Shire Pharmaceuticals Inc. Dory Solomon - Employee, Shire Pharmaceuticals Inc. Mary Palmen - Employee, Shire Pharmaceuticals Inc. Karen Barrett - Employee, Shire Pharmaceuticals Inc. This study was funded by Shire Pharmaceuticals Inc.Figure