3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: A double-blind, double-dummy, randomised trial

Background and aims: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9 mg budesonide once daily (OD) versus 3 g mesalazine granules OD. Methods: This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) 6 and Endoscopic Index (EI) 4, received budesonide (Budenofalk (R) 3 mg capsules x 3) or mesalazine (Salofalk 1000 mg granules x 3). The primary endpoint was clinical remission at week 8 (CAI 4 with stool frequency and rectal bleeding subscores of 0). Results: 343 patients were randomised (177 budesonide, 166 mesalazine). Fewer patients achieved the primary endpoint with budesonide versus mesalazine (70/177 [39.5%] versus 91/166 [54.8%]) with a difference in proportions of -15.3% (95% CI [-25.7%, -4.8%]; p=0.520 for non-inferiority). The median time to first resolution of symptoms was 14.0 days (budesonide) and 11.0 days (mesalazine) (hazard ratio 1.19; 95% CI [0.94, 1.51]). Mucosal healing was observed in 54/177 (30.5%) budesonide patients versus 65/166 (39.2%) mesalazine patients, a difference of -8.6% (95% CI [-18.7%, 1.4%]; p=0.093). The incidences of adverse events (budesonide 26.6%, mesalazine 25.3%) and serious adverse events (budesonide 1.7%, mesalazine 1.2%) were similar. Conclusions: Once-daily 3 g mesalazine administered as granules is superior to 9 mg budesonide OD administered as capsules for achieving remission in mild-to-moderately active UC. However, it is noteworthy that remission of UC was attained in about 40% of budesonide-treated patients with a rapid onset of resolution. (C) 2010 Published by Elsevier B.V. on behalf of European Crohn's and Colitis Organisation.