Inflammatory bowel disease

Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis

M A Kamm¹, G R Lichtenstein², W J Sandborn³, S Schreiber⁴, K Lees⁵, K Barrett⁶, R Joseph⁵

¹ Department of Medicine, St Vincent’s Hospital, Melbourne, Australia
² Division of Gastroenterology, University of Pennsylvania, Philadelphia, USA
³ Inflammatory Bowel Disease Clinic, Mayo Clinic, Rochester, Minnesota, USA
⁴ First Department of Medicine, Christian-Albrechts-Universität, Kiel, Germany
⁵ Shire Pharmaceuticals Inc., Wayne, Philadelphia, USA
⁶ Shire Pharmaceuticals Inc., Basingstoke, Hampshire, UK

Professor M A Kamm, St Vincent’s Hospital, University Department of Medicine, Victoria Parade, Fitzroy 3065, Melbourne, Australia; Kamm{at}ic.ac.uk

Aim: Maintenance treatment in ulcerative colitis should be as convenient as possible, to increase the chance of compliance. MMX mesalazine is a once-daily, high-strength (1.2 g/tablet) formulation of 5-aminosalicylic acid. This study evaluated the safety and efficacy of MMX mesalazine dosed once or twice daily as maintenance therapy in patients with ulcerative colitis.

Methods: This multicentre, randomised, open-label trial enrolled patients with strictly defined clinical and endoscopic remission, immediately following an episode of mild to moderate ulcerative colitis. Patients were randomised to MMX mesalazine 2.4 g/day as a single (2x1.2 g tablet) or divided dose (1x1.2 g tablet twice daily) for 12 months.

Results: 174 patients (37.9%; safety population n = 459) experienced 384 adverse events, the majority of which were mild or moderate in intensity. Eighteen patients (3.9%), nine in each group, experienced a total of 22 serious adverse events (10 in the once-daily and 12 in the twice-daily group). Most serious adverse events were gastrointestinal, experienced by 5 patients in the once-daily and 4 in the twice-daily group. At month 12, 64.4% (efficacy population, n = 451) of patients in the once-daily and 68.5% of patients in the twice-daily group were in clinical and endoscopic remission (p = 0.351). At month 12, 88.9% and 93.2% in each group, respectively, had maintained clinical remission (were relapse free).

Conclusions: MMX mesalazine 2.4 g/day administered as a single or divided dose demonstrated a good safety profile, was well tolerated and was effective as maintenance treatment. High clinical and endoscopic remission rates can be achieved with once-daily dosing.

Trial registration number: NCT00151944.

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