Once-daily budesonide MMX^® in active, mild to moderate ulcerative colitis: results from the randomised CORE II study

Travis SPL, et al. Gut. 2014;63:433–441. doi:10.1136/gutjnl-2012-304258.

Objectives

To compare the efficacy of budesonide MMX^® (CORTIMENT^®) with placebo, in patients with active, mild to moderate ulcerative colitis.

Design

Phase III, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial carried out in 15 countries in Europe.

Primary endpoint

Combined clinical and endoscopic remission at week 8 (defined as a UC-DAI score ≤1, 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).

Methods

Patients were randomised to receive 9 mg or 6 mg of CORTIMENT^®, or 9 mg of Entocort EC or placebo, once-daily for 8 weeks

^{UC-DAI = UC disease activity index}

• Male or female, aged 18-75 years
• History of UC for > 6 months
• Experience mild or moderate flare of UC with UC-DAI score ≥ 4 and ≤ 10
• Histological evidence of active colitis
• At the screening visit, patients on oral 5-ASA and rectal 5-ASA medications were required to undergo a washout of medication for at least 2 days and 4 weeks, respectively, before randomisation

^{UC-DAI = UC disease activity index}

• Limited proctitis (limited to the rectum ≤ 15 cm above the dentate line)
• Use of:
  • Oral or rectal steroids in the last 4 weeks
  • Immunosuppressive agents in the last 8 weeks
  • Anti-TNF agents in the last 3 months

^{anti-TNF = anti-tumor necrosis factor,
UC-DAI = UC disease activity index}