Long-term Compliance with Mesalamine Therapy in Patients with Quiescent Ulcerative Colitis: Results from a Long-term Phase IV Study of MMX® Mesalamine

Abstract

Purpose: Patients with quiescent ulcerative colitis (UC) are often required to remain on long-term maintenance therapy to prevent recurrence of active disease. However, patients frequently report forgetting to take their medication, particularly in the absence of symptoms. This may be made worse by the requirement for multiple tablets, with multiple times daily administration. MMX® mesalamine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Ltd., Ireland) features a low pill burden and once-daily (QD) dosing. In this analysis of a long-term phase IV maintenance study using MMX mesalamine, we examine compliance over time with a once-daily mesalamine formulation. 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 [2.4-4.8g/day; acute phase]) received MMX mesalamine 2.4g/day QD for 12 months (maintenance phase). We examined compliance at 6 months, and 12 months after entry to the maintenance phase. Compliance was assessed via prescription refill data using the formula: [sum of days' supply dispensed]/[sum of days in all refill intervals] x 100. Patients who took ≥80% of study medication were considered to be compliant. Results: In total, 208 patients were enrolled to the 12-month maintenance phase, and 207 were included in the maintenance phase efficacy population. During the maintenance phase, 79.2 and 77.3% of patients remained compliant with their prescribed treatment at 6 and 12 months, respectively. Considering all patients, average compliance with MMX mesalamine in was 86.7% by month 12. Compliance was similar in patients who entered the maintenance phase directly (87.3%) and those who first required acute treatment with MMX mesalamine to achieve disease quiescence (84.8%). Examination of patient outcomes according to some predefined patient and disease characteristics did not identify any significant differences. Conclusion: In this study, the majority of patients were compliant with MMX mesalamine after 6 months treatment, and a similar proportion were also complaint after 12 months. Additionally, compliance was maintained regardless of previous treatment and was equally high in patients who entered the maintenance phase directly, and those who required additional acute phase treatment with MMX mesalamine to achieve disease quiescence. This research was funded by Shire Pharmaceuticals Inc. Disclosure: Sunanda Kane - Research Funding 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.