ORAL BUDESONIDE IN ACTIVE CROHNS-DISEASE

We studied the efficacy and safety of the topically acting steroid bud esonide in an oral preparation for controlled ileal release in an open , uncontrolled trial. Twenty-one patients with active Crohn's disease localized to the distal ileum, ileocaecal region or ascending colon, e ntered the trial. The median age was 36 years and the median duration of Crohn's disease was 8 years. The patients received budesonide, in a controlled ileal release preparation, in a dose of 3 mg t.d.s. for 12 weeks, followed by a reduction to 2 mg t.d.s. for 6 weeks and finally to 1 mg t.d.s. for an additional 6 weeks. Primary variables were the modified Crohn's disease activity index (mCDAI), laboratory parameters and plasma cortisol levels. The mean mCDAI at entry was 268 (+/- 71 s .d.), dropping to 146 (+/- 91 s.d.) after 4 weeks of treatment and to 122 (+/- 87 s.d.) after a total of 12 weeks on 3 mg t.d.s. (P < 0.001) . Following dose reduction, the mean mCDAI increased after 18 and 24 w eeks of treatment. The erythrocyte sedimentation rate also fell signif icantly during the study period. Eighteen patients responded favourabl y during the first 12-week treatment period, and 13 completed the tria l. Seven patients were withdrawn due to failure of treatment after red uction of dose, and four of those were treated surgically. No serious side-effects or significant corticosteroid-related side-effects occurr ed. The mean plasma cortisol levels decreased, but remained within nor mal range. Four patients were markedly suppressed on the highest dose of budesonide. The controlled ileal release of budesonide seems to be beneficial in active ileal and ileocolonic Crohn's disease without cau sing important side-effects.