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

Michael A Kamm ^1*, Gary R Lichtenstein ², William J Sandborn ³, Stefan Schreiber ⁴, Kirstin H Lees ⁵, Karen Barrett ⁶ and Raymond E Joseph ⁵

¹ St Vincent's Hospital, Australia
² University of Pennsylvania, United States
³ Mayo Clinic, United States
⁴ Christian-Albrechts-Universität, Germany
⁵ Shire Pharmaceuticals Inc., United States
⁶ Shire Pharmaceuticals Inc., United Kingdom

^* To whom correspondence should be addressed. E-mail: kamm{at}ic.ac.uk.

Accepted 28 January 2008

Abstract

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 (2 x 1.2 g tablet) or divided dose (1 x 1.2 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%), 9 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.

Keywords: Inflammatory bowel disease, MMX mesalazine, Ulcerative colitis

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