Budesonide multimatrix is efficacious for mesalazine-refractory, mild to moderate ulcerative colitis: A randomised, placebo-controlled trial

Objectives

To compare the efficacy of Cortiment for induction of remission in patients with mild to moderate ulcerative colitis refractory to baseline mesalazine therapy.

Design

A randomised, double-blind, placebo-controlled, multicentre trial conducted in the USA, Canada and Europe

Primary endpoint

The percentage of patients achieving combined clinical and endoscopic remission at week 8

A UC-DAI score ≤1 with subscale scores of 0 for:

• Stool frequency
• Rectal bleeding
• Mucosal appearance

Methods

Patients (n=510) were randomised 1:1 to receive budesonide MMX 9 mg or placebo once daily after breakfast for 8 weeks in an outpatient setting. Patients continued baseline treatment with oral mesalazine ≥ 2.4 g/day.

Secondary Endpoint

The percentage of patients achieving clinical remission [UCDAI subscale scores of 0 for rectal bleeding and stool frequency] and the percentage of patients achieving endoscopic remission [UCDAI subscale score of 0 for mucosal appearance] at Week 8. An exploratory endpoint included the percentage of patients achieving histological healing [histological activity grade of 0] at Week 8

• Male or female, aged 18-75 years
• Active UC with a UC-DAI mucosal appearance subscale score ≥1
• Mild or moderate UC with a baseline UC-DAI score ≥4 and ≤10, mucosal appearance sub score ≥1, and physician’s rating of disease activity score of 1 or 2
• Receiving oral mesalazine ≥2.4 g/day (or equivalent) for ≥6 weeks before randomisation

• Limited distal proctitis
• Diagnosis of Crohn’s disease, indeterminate colitis or infectious colitis
• A history of pancolitis for ≥8 years or left-sided colitis for ≥15 years without surveillance or liver cirrhosis, hepatic or renal disease insufficiency
• Use of:
  • Budesonide MMX^® oral corticosteroids during the previous 4 weeks
  • Rectal mesalazine or corticosteroid formulation during the previous 2 weeks
  • Immunosuppressive agents during the previous 8 weeks
  • Biologic therapies during the previous 3 months
  • Systemic or rectal steroids, any mesalazine other than the existing oral mesalazine at the same dose a patient was receiving at study initiation
  • Anti-tumour necrosis factor-a agents and other biologics, and immunosuppressants

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