BACKGROUND: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately
active ileocolonic Crohn's disease. However, there is no precise recommendation for
budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may
improve adherence and thereby efficacy. METHODS: An eight-week, double-blind, double-dummy
randomised trial compared budesonide 9 mg OD versus 3mg three-times daily (TID) in
patients with mild-to-moderately active ileocolonic Crohn's disease. Primary endpoint
was clinical remission defined as CDAI <150 at week 8 (last observation carried forward).
RESULTS: The final intent-to-treat population comprised 471 patients (238 [9 mg OD],
233 [3 mg TID]). The confirmatory population for the primary endpoint analysis was
the interim per protocol population (n=377; 188 [9 mg OD], 189 [3mg TID]), in which
the primary endpoint was statistically non-inferior with budesonide 9 mg OD versus
3 mg TID. Clinical remission was achieved in 71.3% versus 75.1%, a difference of -3.9%
(95% CI [-14.6%; 6.4%]; p=0.020 for non-inferiority). The mean (SD) time to remission
was 21.9 (13.8) days versus 21.4 (14.6) days with budesonide 9 mg OD versus 3 mg TID,
respectively. In a subpopulation of 122 patients with baseline SES-CD ulcer score
>/=1, complete mucosal healing occurred in 32.8% (21/64) on 9 mg OD and 41.4% (24/58)
on 3mg TID; deep remission (mucosal healing and clinical remission) was observed in
26.6% (17/64) and 32.8% (19/58) of patients, respectively. Treatment-emergent suspected
adverse drug reactions were reported in 4.6% of 9 mg OD and 4.7% of 3 mg TID patients.
CONCLUSIONS: Budesonide at the recommended dose of 9 mg/day can be administered OD
without impaired efficacy and safety compared to 3mg TID dosing in mild-to-moderately
active Crohn's disease.
