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

• Published in: Journal of Crohn's and colitis Vol. 5; no. 2; pp. 129 - 138
• Main Authors: Gross, Volker, Bunganic, Ivan, Belousova, Elena A., Mikhailova, Tatyana L., Kupcinskas, Limas, Kiudelis, Gediminas, Tulassay, Zsolt, Gabalec, Libor, Dorofeyev, Andrey E., Derova, Jelena, Dilger, Karin, Greinwald, Roland, Mueller, Ralph
• Format: Journal Article
• Language: English
• Published: England Elsevier B.V 01.04.2011
• Subjects: Adult; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - therapeutic use; Anti-Inflammatory Agents, Non-Steroidal - administration & dosage; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Budesonide; Budesonide - adverse effects; Budesonide - therapeutic use; Chi-Square Distribution; Colitis, Ulcerative - blood; Colitis, Ulcerative - drug therapy; Double-Blind Method; Female; Humans; Hydrocortisone - blood; Kaplan-Meier Estimate; Male; Mesalamine - adverse effects; Mesalamine - therapeutic use; Mesalazine; Middle Aged; Randomised clinical trial; Remission; Remission Induction; Ulcerative colitis; PP; HI; Budesonide; AE; EI; LOCF; Randomised clinical trial; CI; ITT; CAI; TID; UC; SD; Mesalazine; OD; Remission; Ulcerative colitis
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1016/j.crohns.2010.11.006

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. 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”). 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 11.0days (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. 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.