BUDESONIDE VERSUS PREDNISONE IN THE TREATMENT OF ACTIVE CROHNS-DISEASE

Background & Aims: Budesonide (BUD) is a potent steroid that undergoes extensive first-pass metabolism. BUD incorporated in a pH-dependent f ormulation has been proposed as an alternative treatment for Crohn's d isease (CD). The aim of this study was to compare the efficacy and saf ety of BUD and prednisone (PRED) in the treatment of active CD involvi ng the terminal ileum and/or the colon. Methods: Patients with mild to moderately active CD were included in a randomized, double-blind, dou ble-dummy controlled trial. Patients received either 9 mg BUD once dai ly for 8 weeks or 40 mg PRED once daily for the first 2 weeks tapered gradually to 5 mg/day by the end of the study. Disease activity, quali ty of life, and laboratory parameters were recorded. Results: One hund red patients received BUD, and 101 patients received PRED. By intentio n-to-treat analysis, treatment efficacy defined as Crohn's Disease Act ivity Index of <150 at completion was 51% and 52.5% for the BUD and PR ED groups, respectively. Twice as many responded to treatment with no side effects in the BUD compared with the PRED group (30% vs. 14%) (P = 0.006). Most of the decrease in CDAI scores occurred during the firs t 2 weeks. Conclusions: BUD is as effective as PRED in the treatment o f CD involving the terminal ileum and right colon. BUD has significant ly fewer steroid-related adverse reactions.