Induction of clinical and colonoscopic remission of mild-to-moderate ulcerative colitis with budesonide MMX 9 mg: pooled analysis of two phase 3 studies

Aliment Pharmacol Ther. 2015 Mar;41(5):409-18. doi: 10.1111/apt.13076. Epub 2015 Jan 15.

Abstract

Background: Conventional oral corticosteroids are effective at reducing inflammation associated with ulcerative colitis (UC); however, systemic adverse effects limit their use. Budesonide MMX is an extended-release, second-generation corticosteroid that targets delivery of budesonide to the entire colon.

Aim: To analyse efficacy and safety outcomes from two phase 3 studies of budesonide MMX in patients with mild-to-moderate active UC.

Methods: Patients were assigned to budesonide MMX 9 mg, budesonide MMX 6 mg, or placebo once daily in two randomised, double-blind, placebo-controlled, 8-week studies (CORE I and II). Pooled data were analysed for pre-defined primary (combined clinical and colonoscopic remission), secondary and exploratory endpoints. Primary endpoint data were analysed to evaluate the potential influence of demographical and baseline disease characteristics on remission.

Results: Modified intent-to-treat population (histological evidence of baseline inflammation) had 232, 230 and 210 patients in budesonide MMX 9 mg, budesonide MMX 6 mg and placebo groups respectively. Combined clinical and colonoscopic remission rates were significantly greater than placebo (6.2%) for the budesonide MMX 9 mg group (17.7%; P = 0.0002), but not the budesonide MMX 6 mg group (10.9%). The primary endpoint of remission with budesonide MMX 9 mg was significantly greater than placebo in most subgroups analysed. Symptom resolution and colonoscopic improvement rates were significantly greater with budesonide MMX 9 mg vs. placebo. Budesonide MMX was safe and well tolerated.

Conclusion: This pooled analysis showed that budesonide MMX 9 mg is efficacious, safe and well tolerated for inducing remission of mild-to-moderate UC.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Budesonide / administration & dosage
  • Budesonide / adverse effects
  • Budesonide / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Colitis, Ulcerative / drug therapy*
  • Colonoscopy
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gastrointestinal Agents / administration & dosage
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Male
  • Mesalamine / therapeutic use
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Remission Induction
  • Socioeconomic Factors
  • Young Adult

Substances

  • Delayed-Action Preparations
  • Gastrointestinal Agents
  • Mesalamine
  • Budesonide