Gr. Greenberg et al., ORAL BUDESONIDE AS MAINTENANCE TREATMENT FOR CROHNS-DISEASE - A PLACEBO-CONTROLLED, DOSE-RANGING STUDY, Gastroenterology, 110(1), 1996, pp. 45-51
Background & Aims: Budesonide is a corticosteroid with high topical an
ti-inflammatory activity and low systemic activity due to rapid hepati
c metabolism, The efficacy and safety of an oral controlled-release pr
eparation 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 rece
ive 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 Activ
ity 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, B
asal plasma cortisol levels and incidence of corticosteroid-associated
effects were similar in the three groups, Conclusions: Oral controlle
d-release budesonide (6 mg/day) was well tolerated and prolonged remis
sion in Crohn's disease of the ileum and proximal colon, but this effe
ct was not sustained at 1-year follow-up.