A COMPARISON OF BUDESONIDE WITH PREDNISOLONE FOR ACTIVE CROHNS-DISEASE

Background. Patients with active Crohn's disease are often treated wit h corticosteroids, but the treatment has many side effects. Budesonide is a potent, well-absorbed corticosteroid, but because of a high rate of first-pass metabolism in the liver, its systemic bioavailability i s low. Methods. We conducted a randomized, double-blind, 10-week trial comparing the efficacy and safety of an oral controlled-release form of budesonide with the efficacy and safety of prednisolone in 176 pati ents with active ileal or ileocecal Crohn's disease (88 patients in ea ch treatment group). The dose of budesonide was 9 mg per day for eight weeks and then 6 mg per day for two weeks. The dose of prednisolone w as 40 mg per day for two weeks, after which it was gradually reduced t o 5 mg per day during the last week. Results. At 10 weeks, 53 percent of the patients treated with budesonide were in remission (defined as a score less than or equal to 150 on the Crohn's disease activity inde x), as compared with 66 percent of those treated with prednisolone (P = 0.12). The mean score on the Crohn's disease activity index decrease d from 275 to 175 in the budesonide group and from 279 to 136 in the p rednisolone group (P = 0.001). Corticosteroid-associated side effects were significantly less common in the budesonide group (29 vs. 48 pati ents, P = 0.003). Two patients in the prednisolone group had serious c omplications (one had intestinal perforation and one an abdominal-wall fistula). The mean morning plasma cortisol concentration was signific antly lower in the prednisolone group than in the budesonide group aft er 4 weeks (P < 0.001) and 8 weeks (P = 0.02) of therapy, but not afte r 10 weeks. Conclusions. Among patients with active Crohn's disease, b oth controlled-release budesonide and prednisolone are effective in in ducing remission. In this trial, prednisolone reduced scores on the Cr ohn's disease activity index more, whereas with budesonide there were fewer glucocorticoid-associated side effects and less suppression of p ituitary-adrenal function.