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

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

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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 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® 3 mg capsules × 3) or mesalazine (Salofalk® 1000. mg 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 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.

Original languageEnglish
Pages (from-to)129-138
Number of pages10
JournalJournal of Crohn's and Colitis
Volume5
Issue number2
DOIs
Publication statusPublished - Apr 1 2011

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Keywords

  • Budesonide
  • Mesalazine
  • Randomised clinical trial
  • Remission
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Gross, V., Bunganic, I., Belousova, E. A., Mikhailova, T. L., Kupcinskas, L., Kiudelis, G., Tulassay, Z., Gabalec, L., Dorofeyev, A. E., Derova, J., Dilger, K., Greinwald, R., & Mueller, R. (2011). 3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: A double-blind, double-dummy, randomised trial. Journal of Crohn's and Colitis, 5(2), 129-138. https://doi.org/10.1016/j.crohns.2010.11.006