Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: A multicentre, double-blind, randomized, parallel-group Phase II study

• Published in: Journal of Crohn's and colitis 2013-04, Vol.7 (3), p.239-247
• Main Authors: Suzuki, Yasuo, Motoya, Satoshi, Takazoe, Masakazu, Kosaka, Tadashi, Date, Masataka, Nii, Masahiro, Hibi, Toshifumi
• Format: Article
• Language: English
• Subjects: Administration, Oral; Adolescent; Adult; Aged; Anti-Inflammatory Agents - therapeutic use; Budesonide; Budesonide - therapeutic use; Crohn Disease - drug therapy; Crohn's disease; Double-Blind Method; Drug Administration Schedule; Female; Humans; Induction Chemotherapy; Japan; Japanese patients; Kaplan-Meier Estimate; Male; Middle Aged; Quality of Life; Severity of Illness Index; Treatment Outcome; Young Adult
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1016/j.crohns.2012.06.006

Current treatments for Japanese patients with active Crohn's disease have not proved optimal, and new treatment options are required. The present study therefore evaluated the efficacy and tolerability of oral budesonide in Japanese patients with mild-to-moderate active Crohn's disease. In this multicentre, double-blind, randomized, parallel-group, Phase II study, patients (18–65years) with baseline Crohn's Disease Activity Index (CDAI) score≥200 were randomized to once-daily (od) oral budesonide 9mg or 15mg, or matching placebo, for 8weeks. Concomitant therapy with sulfasalazine or 5-aminosalicylic acid, and nutritional therapy, was allowed. The rate of remission (defined as CDAI score≤150) after 8weeks' treatment (primary variable), health-related quality of life (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ]), and tolerability were assessed. 77 patients were randomized and 63 completed the study. The proportion of budesonide-treated patients with remission after 8weeks' treatment was higher compared with placebo (23.1%, 28.0%, and 11.5% for budesonide 9mg, 15mg, and placebo, respectively; no significant difference). The mean change from baseline to week 8 in CDAI total score (−48.0, −58.2, and −27.2, respectively) and IBDQ total score (10.8, 23.2, and 6.5, respectively) was greater for budesonide-treated patients than placebo recipients. While budesonide 9mg and 15mg demonstrated similar efficacy, budesonide 9mg caused fewer drug- and glucocorticosteroid-related adverse events and less adrenal suppression. Oral budesonide 9mg od (for up to 8weeks) may offer a new treatment option for Japanese patients with mild-to-moderate active Crohn's disease.