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P171. MMX® mesalazine 2.4 g/day for the maintenance of disease quiescence: Efficacy in patients with ulcerative colitis, regardless of prior treatment

P171. MMX® mesalazine 2.4 g/day for the maintenance of disease quiescence: Efficacy in patients with ulcerative colitis, regardless of prior treatment

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: The recommended first-line treatment for patients with mild-to-moderate ulcerative colitis is 5-aminosalicylic acid (5-ASA). In this analysis of a phase IV study, we examine the results of long-term maintenance treatment with MMX® mesalazine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Inc., Ireland) in which patients with quiescent UC, who have either entered the maintenance phase of this study directly, or who have first received induction therapy in the acute phase of the study to achieve quiescence.

Methods: The Strategies in Maintenance for Patients Receiving Long-term Therapy (SIMPLE) study was a phase IV, multicentre, open-label trial conducted in 51 centres in the USA, with the primary objective of investigating the proportion of patients experiencing clinical recurrence when receiving long-term maintenance treatment for quiescent UC (UC-DAI scores of 0 for rectal bleeding and stool frequency). In the maintenance phase of the study, patients with quiescent UC (any previous treatment) received MMX mesalazine 2.4 g/day, given once daily (QD), for 12 months. Patients with active, mild-to-moderate UC were permitted to enter the acute phase, where they received MMX mesalazine 2.4–4.8 g/day, given QD for 8 weeks. Patients who achieved disease quiescence in the acute phase could subsequently enter the maintenance phase.

Results: In total, 208 patients were enrolled to the maintenance phase of the study. Of these, 56 entered via the acute induction phase. A similar proportion of patients remained quiescent over 12 months in both the group who achieved quiescence (any therapy) prior to the study (63%), and those who required acute phase induction therapy with MMX mesalazine (67%).

Conclusions: Approximately two-thirds of patients in both the acute entry and the direct to maintenance groups maintained disease quiescence during this study. These data suggest that MMX mesalazine treatment is equally effective at maintaining patients in disease quiescence, irrespective of whether they achieved quiescence using MMX mesalazine induction therapy, or if they achieved quiescence via another route prior to initiating MMX mesalazine maintenance therapy.

This research was funded by Shire Pharmaceuticals Inc.