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

Background-Steroid dependent patients with Crohn's disease are at high risk of developing glucocorticosteroid induced side effects. Aims-We switching budesonide ((Entocort) in prednisolone/prednisone depende nt patients with inactive Crohn's disease affecting the ileum and/or ascend ing colon. Patients-Steroid dependent patients with a Crohn's disease activity index l ess than or equal to 200 were included. Methods-In a double blind multicentre trial, 120 patients were randomly ass igned to receive budesonide 6 mg once daily or placebo. Prednisolone was ta pered to zero during the first 4-10 weeks and budesonide or placebo was giv en concomitantly and for a further 12 weeks. Relapse was defined as an inde x >200 and an increase of 60 points from baseline or withdrawal due to dise ase deterioration. Results-After one and 13 weeks without prednisolone, relapse rates were 17% and 32%, respectively, in the budesonide group, and 41% and 65% in the pla cebo group (95% confidence intervals for the difference in percentages -41% , -8% and -51%, -16%; p=0.004 and p<0.001, respectively). The number of glu cocorticosteroid side effects was reduced by 50% by switching from predniso lone and was similar in the budesonide and placebo groups. Basal plasma cor tisol increased in both groups. Conclusions-The majority of patients with steroid dependent ileocaecal Croh n's disease may be switched to budesonide controlled ileal release capsules 6 rug without relapse, resulting in a sharp decrease in glucocorticosteroi d side effects similar to placebo, and with an increase in plasma cortisol levels.