Budesonide for the treatment of inflammatory bowel disease

Abstract

While corticosteroids are the effective treatment for the symptomatic management of patients with inflammatory bowel disease (IBD), they cause serious side effects. Budesonide is a nonhalogenated glucocorticosteroid structurally related to 16 alpha-hydroxy-prednisolone that possesses high topical anti-inflammatory activity and low systemic activity compared with the conventional steroids prednisone and prednisolone. This favourable activity ratio is achieved because a high affinity to the steroid receptor is coupled with rapid hepatic conversion to metabolites with minimal or no biological activity. Controlled trials in patients with distal ulcerative colitis indicate that budesonide enemas have equivalent or superior efficacy compared with 5-aminosalicylic acid (5-ASA) enemas, prednisolone disodium phosphate enemas or methylprednisolone enemas, without causing significant depression of endogenous cortisol levels. Two controlled trials investigating the efficacy of an oral controlled-ileal release form of budesonide for active Crohn's disease have recently been completed. In the first trial, after eight weeks' treatment budesonide 9 mg daily caused clinical remission in 51% of patients, compared with 20% of patients receiving placebo. Budesonide caused a dose-related reduction of plasma cortisol responses to adrenocorticotropic hormone stimulation, but was not associated with clinically important corticosteroid-related symptoms or other toxicity. In a second trial, budesonide 9 mg daily was as effective as prednisolone for induction of remission in active ileocecal Crohn's disease. Budesonide is a potentially promising new therapeutic agent for the management of patients with IBD.