NEW YORK (Reuters Health) – Once-daily mesalamine, at a dose of 2.4 g, offers maintenance of remission of ulcerative colitis similar to that provided by twice-daily mesalamine at a total daily dose of 1.6 g, according to a report in the May 8th American Journal of Gastroenterology.
Mesalamine is the treatment of choice for ulcerative colitis, and its efficacy to maintain clinical remission and/or mucosal healing has been established in several randomized controlled trials.
Dr. Geert D’Haens from Academic Medical Center, Amsterdam, The Netherlands and colleagues compared the efficacy of a once-daily formulation of mesalamine (2.4 g/day) with that of twice-daily delayed-release mesalamine (1.6 g/day) for maintenance of endoscopic remission in 826 patients with ulcerative colitis who had been treated for acute relapse in the past 12 months.
In the per-protocol analysis, there was no significant difference in the percentage of patients that maintained endoscopic remission at 6 months in the once-daily mesalamine group (287/343, 83.7%) and in the twice-daily mesalamine group (274/336, 81.5%).
Results were similar for the comparison of the intent-to-treat population (323/415, 77.8% versus 316/411, 76.9%, respectively).
Maintenance of endoscopic remission with no or mild symptoms, time to relapse, and modified ulcerative colitis disease activity index scores did not differ significantly between the treatments.
Treatment-emergent adverse events occurred with similar frequency with once-daily mesalamine (154/415, 37.1%) and twice-daily mesalamine (148/411, 36.0%), and the incidence of the most common adverse events was similar in both treatment groups.
“Once-daily dosing of MMX mesalamine 2.4 g/day was shown to be well tolerated and non-inferior to twice-daily dosing with delayed-release mesalamine 1.6 g/day for maintenance of remission in patients with ulcerative colitis,” the researchers conclude.
The investigators did not explain why they chose to compare different total daily doses of mesalamine, and an email query to Dr. D’Haens went unanswered.
The study was funded by Shire Development LLC, which also provided research funding and honoraria to 2 of the authors. The remaining 3 authors are employed by Shire Development LLC or Shire Pharmaceutical Development Ltd.
SOURCE:
Once-Daily MMX® Mesalamine for Endoscopic Maintenance of Remission of Ulcerative Colitis
