ORAL BUDESONIDE THERAPY FOR STEROID-DEPENDENT ULCERATIVE-COLITIS - A PILOT TRIAL

Background: Budesonide, a corticosteroid with high topical anti-inflam matory activity and low systemic activity, has been shown to prolong t ime to relapse in Crohn's disease. In the present study, the efficacy of budesonide in an oral pa-modified-release formulation was evaluated for maintenance treatment in patients with steroid-dependent ulcerati ve colitis. Methods: Fourteen patients with steroid-dependent ulcerati ve colitis in the reduction phase of conventional glucocorticosteroids (c-GCS) following a severe attack, were treated with budesonide 3 mg t.d.s. for 6 months. The primary investigation parameters were changes in the clinical activity index (CAT) and in the daily dose of c-GCS. Results: In 11 cases the CAI improved significantly and treatment with c-GCS could be terminated. Three patients experienced relapse and nee ded further c-GCS treatment. The average daily dose of c-GCS and the a verage value of the CAT before treatment with budesonide were signific antly higher in the relapse group than in the remission group. Conclus ions: In patients with c-GCS-dependent ulcerative colitis, a dose of 9 mg budesonide daily in an oral pH-modified-release formulation was we ll tolerated, significantly decreased the CAI, and rendered c-GCS unne cessary in the majority of cases.