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P198. Assessing relationships between compliance and clinical recurrence in patients with quiescent ulcerative colitis receiving MMX® mesalazine 2.4 g/day as maintenance therapy: The phase IV SIMPLE trial

P198. Assessing relationships between compliance and clinical recurrence in patients with quiescent ulcerative colitis receiving MMX® mesalazine 2.4 g/day as maintenance therapy: The phase IV SIMPLE trial

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: Many standard mesalazine formulations require a large pill burden and multiple-times daily administration which can lead to poor patient compliance. Patients with ulcerative colitis (UC) who do not remain compliant with their prescribed medication risk relapse. MMX® mesalazine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Ltd., Ireland) employs once-daily (QD) dosing with a low pill burden. The Strategies in Maintenance for Patients Receiving Long-term Therapy (SIMPLE) trial was therefore designed to investigate the relationship between compliance with medication and disease recurrence in patients with UC.

Methods: SIMPLE was a phase IV, multicentre, open-label trial conducted in 51 centres in the USA. Patients with quiescent UC (scores of zero for rectal bleeding and bowel movements) at enrolment or after 8 weeks' acute phase treatment with MMX mesalazine 2.4–4.8 g/day, received MMX mesalazine 2.4 g/day QD for 12 months (maintenance phase). The primary outcome measure of the SIMPLE study was disease quiescence (UC-DAI scores of 0 for rectal bleeding and stool frequency) at 6 months. Compliance was evaluated using prescription refill data using the formula: [sum of days' supply dispensed]/[sum of days in all refill intervals] × 100; patients filling <80% of prescriptions were considered to be noncompliant.

Results: Overall, 208 patients entered the 12-month maintenance period; 207 were included in the efficacy population. Many patients did not experience clinical recurrence at either 6 or 12 months (77 and 64%, respectively). A substantial proportion of patients (77%) took ≥80% of the study medication and were considered to be compliant up to Month 12. A similar proportion (79%) were compliant at Month 6. Disease recurrence was more frequent among noncompliant patients, compared with compliant patients at both 6 (nominal p = 0.0476) and 12 months (nominal p = 0.0120) (Table).

Table.
 Compliant patients (compliance: ≥80%), Noncompliant patients (compliance: <80%)
 Recurrence (%)No recurrence (%)Recurrence (%)No recurrence (%)
6 monthsn = 160n = 36
 20.679.436.163.9
12 monthsn = 154n = 40
 31.268.852.547.5

Conclusions: Over three-quarters of patients were compliant with once-daily MMX mesalazine therapy at both 6 and 12 months. During this study, recurrence rates were higher in noncompliant patients, compared with compliant patients. Therefore, clinical outcomes may be associated with compliance and so choosing medication that enhances compliance could benefit patient remission.

This research was funded by Shire Pharmaceuticals Inc.