Mesalazine in left-sided ulcerative colitis: Efficacy analyses from the PODIUM trial on maintenance of remission and mucosal healing

Background and aim: Left-sided colitis is the most prevalent subtype of ulcerative colitis, a chronic inflammatory disease of the colon. The standard of care for mild-to-moderate ulcerative colitis is mesalazine. The PODIUM study compared a once daily to a twice daily dosing regimen of a slow-release mesalazine (Pentasa(R) ); here we assess the efficacy, in terms of maintenance of remission and mucosal healing, of both regimens in patients with left-sided disease. Patients and methods: Eligible patients were randomised to once daily (1 x 2 g) or twice daily (2 x 1 g) oral treatment with mesalazine, for 12 months. Disease activity was assessed clinically and endoscopically at baseline and at 12 months using the Ulcerative Colitis Disease Activity Index, without endoscopic assessment at months 4 and 8. Results: The study met the primary endpoint of non-inferiority in terms of remission, for once daily versus twice daily dosing, in patients with left-sided ulcerative colitis; an 8% difference was reported in the 12-month clinical and endoscopic remission rates (69% [95% CI: 59.5-76.5] and 61% [95% Cl: 51.4-69.6] with once daily and twice daily dosing, respectively; p=0.310). Mucosal healing scores after 12 months were 0 or 1 for 84.4% of the once daily and 78.8% of the twice daily population. Slow-release mesalazine was well tolerated in both dosing regimens, with no difference in reported adverse events. Conclusions: Once daily slow-release mesalazine is similarly effective to the standard twice daily schedule in patients with left-sided ulcerative colitis for the maintenance of remission in mild-to-moderate disease. (C) 2011 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.