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Crohn's disease (CD) is an inflammatory bowel disorder often initiated by an acute attack and may become chronic in some patients. Systemic glucocorticosteroids (GCS), such as prednisolone and prednisone, are commonly used in the treatment of acute attacks of the disease. 1 2 Approximately one third of patients initially treated with GCS become GCS dependent: they remain in remission while receiving GCS but relapse when they are stopped. 3 However, this treatment is often associated with serious side effects: metabolic (diabetes, hypertension, osteopenia) or cosmetic (moon face, hirsutism, acne).
Budesonide is a GCS with a marked topical anti-inflammatory effect and low systemic activity compared with conventional GCS 4 because of its marked potency combined with a high first pass metabolism (about 90%) to metabolites with minimal or no steroid activity. 4 Budesonide (Entocort) controlled ileal release (CIR) capsules deliver the drug mainly to the ileum and ascending colon. This offers a new topical steroid treatment for patients with ileocolic CD, with a reduced risk of GCS induced side effects. In a placebo controlled dose finding study, budesonide CIR capsules were significantly more effective than placebo in inducing remission of active CD affecting the ileum and/or ascending colon, with an optimal dose of 9 mg daily. 5 Budesonide 9 mg daily has also been found to be as effective as oral prednisolone 6 7 but with fewer GCS induced side effects. In addition, budesonide CIR capsules have been shown to significantly prolong the time to relapse in patients with quiescent disease. 8-10
We evaluated the effect of replacing prednisolone/prednisone with budesonide in steroid dependent patients with the possibility of improved tolerability.
Materials and methods
PATIENT SELECTION
The study was performed between April 1996 and October 1998. Eligible patients were at least 18 years of age and had inactive CD, as defined by a Crohn's disease activity index (CDAI) [= or <, slanted]200. The index assesses eight variables: number of liquid stools, extent of abdominal pain, general well being, occurrence of extraintestinal symptoms, need for antidiarrhoeal drugs, presence of abdominal masses, haematocrit, and body weight. 11 Relapse was defined as a score >200 and an increase of at least 60 points from baseline. Disease extent had to be confined mainly to the distal ileum, ileocaecal region,...