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P199. Symptom improvement in mild-to-moderate ulcerative colitis after 1 week's acute treatment with MMX® mesalazine 2.4 g/day

P199. Symptom improvement in mild-to-moderate ulcerative colitis after 1 week's acute treatment with MMX® mesalazine 2.4 g/day

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: Ulcerative colitis frequently causes a number of distressing and unpleasant symptoms for sufferers, but this can be successfully treated. The compound 5-aminosalicylic acid (5-ASA) is the recommended first-line treatment for UC. In this phase IV study, patients received long-term maintenance therapy with MMX® mesalazine (Shire Pharmaceuticals Inc., USA; MMX, Cosmo Technologies Ltd., Ireland). Patients who did not have quiescent disease at the start of the study were eligible to receive acute treatment. Here, we examine improvement in patients' major clinical symptoms (stool frequency and rectal bleeding) after 1 week of treatment among patients in the acute phase.

Methods: The SIMPLE (Strategies in Maintenance for Patients Receiving Long-term Therapy) study was a phase IV, multicentre, open-label study conducted in 51 centres in the USA. Patients with quiescent UC were enrolled to receive MMX mesalazine maintenance phase treatment of 2.4 g/day, once daily (QD) for 12 months. However, patients with active disease could enter an 8-week acute phase of the trial, where they received MMX mesalazine 2.4–4.8 g/day, QD. Patients who achieved disease quiescence could subsequently enter the maintenance phase of the trial. Disease quiescence was defined as scores of zero for both rectal bleeding and bowel movements.

Patients recorded their symptoms once daily during the acute phase, scoring frequency of bowel movements above normal per day (0–2), urgency (0–2), abdominal pain (0 or 1) and rectal bleeding (0–3). Here, we examine these symptoms scores after 1 week of acute phase treatment.

Figure. Time to symptom resolution (combined analysis for both rectal bleeding and bowel movements).

Results: In total, 138 patients were enrolled to the acute treatment phase of the SIMPLE study. After 7 days of treatment, 22% of patients reported complete resolution (symptom scores of 0) of both rectal bleeding and frequency of bowel movements (Figure). Separate Kaplan–Meier curves for rectal bleeding or stool frequency symptoms suggest that approximately 25% of patients achieved resolution of rectal bleeding and approximately 35% achieved bowel movement normalisation within one week of initialising treatment.

Conclusions: Patients who received acute induction therapy with MMX mesalazine reported improvements in UC symptoms as soon as 1 week after starting their therapy. Cessation of both rectal bleeding and normalisation of stool frequency was reported by over a fifth of patients, while over a third of patients reported resolution of bowel movements and approximately a quarter reported resolution of rectal bleeding during the first week of treatment.

This research was funded by Shire Pharmaceuticals Inc.