Clinical Symposium on the Inflammatory Bowel Disease on the Doctor in Focus location:Montreux, Switzerland date:4-5 Feb 2000
This trial evaluated the possibility of switching from systemic steroids to budesonide (Entocort(R)) in prednisolone/prednisone-dependent patients with inactive Crohn's disease affecting the ileum and/or the ascending colon. In a double-blind, multicenter trial, 120 patients were randomly assigned to receive budesonide 6 mg once daily or placebo. Prednisolone was tapered to zero during the first 4-10 weeks and budesonide or placebo was given concomitantly and after cessation of prednisolone for a further 12 weeks. Relapse was defined as a Crohn's disease activity index >200 and an increase of 60 points from baseline or withdrawal due to disease deterioration. It was found that after 1 and 13 weeks without prednisolone, the relapse rates were 17% and 32%, respectively, in the budesonide group and 41% and 65% in the placebo group (p = 0.004 and p < 0.001, respectively). The number or glucocorticosteroid side effects was reduced by 50% by switching from prednisolone and was similar in the budesonide and the placebo groups. The majority of patients with steroid-dependent ileocecal Crohn's disease may be switched to 6 mg budesonide controlled ileal release capsules without relapse, resulting in a sharp decrease in glucocorticosteroid side effects.