Supplementary Material for: Efficacy and Safety of Oral Budesonide in Patients with Active Crohn's Disease in Japan: A Multicenter, Double-Blind, Randomized, Parallel-Group Phase 3 Study
<p><b><i>Background:</i></b> US and European guidelines recommend
budesonide for the treatment of mild-to-moderate active ileocolic
Crohn's disease (CD). However, budesonide has not been approved, and
mesalazine is widely used as first-line treatment in Japan. The
objective of this study was to evaluate the efficacy and safety of
budesonide in patients with mild-to-moderate active CD in Japan. <b><i>Methods:</i></b>
In this phase 3 noninferiority study (NCT01514240), 112 patients with a
baseline Crohn's Disease Activity Index (CDAI) score of 180-400 were
randomized to budesonide or mesalazine for 8 weeks. Assessments included
remission rate (CDAI score ≤150) at weeks 2, 4, and 8, change in CDAI
score, health-related quality of life (measured using the Inflammatory
Bowel Disease Questionnaire [IBDQ]), and tolerability. <b><i>Results:</i></b>
The remission rate at week 8 was numerically higher in the budesonide
group (30.4%) than in the mesalazine group (25.0%), and the
noninferiority of budesonide to mesalazine was shown. The mean total
CDAI score decreased to a greater extent with budesonide than with
mesalazine. Mean IBDQ scores improved from baseline to weeks 2, 4, 8,
and 10 in both groups; improvements were numerically higher with
budesonide than with mesalazine. No safety concerns were found. <b><i>Conclusion:</i></b> Budesonide is comparably effective to mesalazine in the treatment of Japanese patients with mild-to-moderate active CD.</p
