BUDESONIDE PROLONGS TIME TO RELAPSE IN ILEAL AND ILEOCECAL CROHNS-DISEASE - A PLACEBO-CONTROLLED ONE-YEAR STUDY

Background and Aims-To evaluate the efficacy and safety of the topical corticosteroid budesonide, given in an oral controlled release formul ation for maintenance of remission in patients with ileal and ileocaec al Crohn's disease (CD).Patients and Methods-Out of 176 patients with active CD who had achieved remission (CD activity index score less tha n or equal to 150) after 10 weeks' treatment with either budesonide or prednisolone, 90 were randomised to continue with once daily treatmen t of 6 mg budesonide, or 3 mg budesonide or placebo for up to 12 month s in a double blind, multicentre trial. Time to symptomatic relapse wa s calculated using Kaplan-Meier estimates. Morning plasma cortisol was measured at clinic visits and a corticotropin stimulation test was pe rformed after three months of treatment. Results-Thirty two patients w ere allocated to the 6 mg budesonide group, 31 to the 3 mg group, and 27 to the placebo group. After three months, 19 per cent of the patien ts in the 6 mg group had relapsed, compared with 45 per cent in the 3 mg group and 44 per cent in the placebo group (p=0.047). The correspon ding results after 12 months was 59 per cent in the 6 mg budesonide gr oup, 74 per cent in the 3 mg group, and 63 per cent in the placebo gro up (p=0.44), The median time to relapse or discontinuation was 258 day s In the 6 mg group, 139 days in the 3 mg group, and 92 days in, the p lacebo group (p=0.021). Mean morning plasma cortisol values increased from entry in all three groups with no statistically significant diffe rences at 12 months. All 13 patients remaining in the placebo group af ter three months had a normal corticotropin stimulation response, comp ared with 18 of 23 patients in the 6 mg, and 19 of 21 in the 3 mg bude sonide groups (p=0.14). Acne and moon face were slightly more common i n the budesonide groups. Conclusion-6 mg budesonide once daily is sign ificantly more efficacious than placebo in prolonging time to relapse in CD, and causes only minor systemic side effects.