title: Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study.
abstract: OBJECTIVE
  Budesonide MMX is a novel oral formulation of budesonide that uses Multi-Matrix System (MMX) technology to extend release to the colon. This study compared the efficacy of budesonide MMX with placebo in patients with active, mild-to-moderate ulcerative colitis (UC).
  
  
  METHODS
  Patients were randomised 1:1:1:1 to receive budesonide MMX 9 mg or 6 mg, or Entocort EC 9 mg (budesonide controlled ileal-release capsules; reference arm) or placebo once daily for 8 weeks. The primary endpoint was combined clinical and endoscopic remission, defined as UC Disease Activity Index score ≤1 with a score of 0 for rectal bleeding and stool frequency, no mucosal friability on colonoscopy, and a ≥1-point reduction in endoscopic index score from baseline.
  
  
  RESULTS
  410 patients were evaluated for efficacy. Combined clinical and endoscopic remission rates with budesonide MMX 9 mg or 6 mg, Entocort EC and placebo were 17.4%, 8.3%, 12.6% and 4.5%, respectively. The difference between budesonide MMX 9 mg and placebo was significant (OR 4.49; 95% CI 1.47 to 13.72; p=0.0047). Budesonide MMX 9 mg was associated with numerically higher rates of clinical (42.2% vs 33.7%) and endoscopic improvement (42.2% vs 31.5%) versus placebo. The rate of histological healing (16.5% vs 6.7%; p=0.0361) and proportion of patients with symptom resolution (23.9% vs 11.2%; p=0.0220) were significantly higher for budesonide MMX 9 mg than placebo. Adverse event profiles were similar across groups.
  
  
  CONCLUSIONS
  Budesonide MMX 9 mg was safe and more effective than placebo at inducing combined clinical and endoscopic remission in patients with active, mild-to-moderate UC.
authors: Translational Gastroenterology Unit, John Radcliffe Hospital, , Oxford, UK.
authors: Simon P L
authors: SP
authors: Travis
authors: Silvio
authors: S
authors: Danese
authors: Limas
authors: L
authors: Kupcinskas
authors: Olga
authors: O
authors: Alexeeva
authors: Geert
authors: G
authors: D'Haens
authors: Peter R
authors: PR
authors: Gibson
authors: Luigi
authors: L
authors: Moro
authors: Richard
authors: R
authors: Jones
authors: E David
authors: ED
authors: Ballard
authors: Johan
authors: J
authors: Masure
authors: Matteo
authors: M
authors: Rossini
authors: William J
authors: WJ
authors: Sandborn
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods*; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations; D019819:Budesonide
keywords: IBD; Inflammatory Bowel Disease; Ulcerative Colitis