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

Abstract

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 9mg budesonide once daily (OD) versus 3g 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® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×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 3g mesalazine administered as granules is superior to 9mg 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.

• Authors: Volker Gross, Ivan Bunganic, Elena A Belousova, Tatyana L Mikhailova, Limas Kupcinskas, Gediminas Kiudelis, Zsolt Tulassay, Libor Gabalec, Andrey E Dorofeyev, Jelena Derova, Karin Dilger, Roland Greinwald, Ralph Mueller, International BUC-57 Study Group
• Journal: Journal of Crohn's & colitis (J Crohns Colitis) Vol. 5 Issue 2 Pg. 129-38 (Apr 2011) ISSN: 1876-4479 [Electronic] England
• PMID: 21453882 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010. Published by Elsevier B.V.

Chemical References

• Anti-Inflammatory Agents
• Anti-Inflammatory Agents, Non-Steroidal
• Mesalamine
• Budesonide
• Hydrocortisone

Topics

• Adult
• Anti-Inflammatory Agents (administration & dosage, therapeutic use)
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, therapeutic use)
• Budesonide (adverse effects, therapeutic use)
• Chi-Square Distribution
• Colitis, Ulcerative (blood, drug therapy)
• Double-Blind Method
• Female
• Humans
• Hydrocortisone (blood)
• Kaplan-Meier Estimate
• Male
• Mesalamine (adverse effects, therapeutic use)
• Middle Aged
• Remission Induction