Switch from systemic steroids to budesonide in steroid-dependent patients with inactive Crohn's disease

This trial evaluated the possibility of switching from systemic steroids to budesonide (Entocort(R)) in prednisolone/prednisone-dependent patients wit h inactive Crohn's disease affecting the ileum and/or the ascending colon. In a double-blind, multicenter trial, 120 patients were randomly assigned t o receive budesonide 6 mg once daily or placebo. Prednisolone was tapered t o zero during the first 4-10 weeks and budesonide or placebo was given conc omitantly and after cessation of prednisolone for a further 12 weeks. Relap se 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 wer e 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 gluco corticosteroid side effects was reduced by 50% by switching from prednisolo ne and was similar in the budesonide and the placebo groups. The majority o f patients with steroid-dependent ileocecal Crohn's disease may be switched to 6 mg budesonide controlled ileal release capsules without relapse, resu lting in a sharp decrease in glucocorticosteroid side effects.