Oral budesonide as maintenance treatment for Crohn's disease: A placebo-controlled, dose-ranging study

Background & Aims: Budesonide is a corticosteroid with high topical anti-inflammatory activity and low systemic activity due to rapid hepatic metabolism, The efficacy and safety of an oral controlled-release preparation of budesonide for maintenance of remission was evaluated in patients with ileal or ileocecal Crohn's disease, Methods: In a double-blind, multicenter trial, 105 patients were randomly assigned to receive placebo or budesonide at doses of 3 or 6 mg daily for 1 year, The primary outcome measure was relapse defined by a Crohn's Disease Activity Index score of >150 and a minimum increase of 60 points, Results: Patients receiving 6 mg of budesonide had a median time to relapse or discontinuation of therapy of 178 days compared with 124 days in those receiving 3 mg of budesonide and 39 days in those receiving placebo. However, at 1 year, the rate of relapse in the group receiving 6 mg of budesonide was similar to the rates in the 3 mg and placebo groups, Basal plasma cortisol levels and incidence of corticosteroid-associated effects were similar in the three groups, Conclusions: Oral controlled-release budesonide (6 mg/day) was well tolerated and prolonged remission in Crohn's disease of the ileum and proximal colon, but this effect was not sustained at 1-year follow-up.