Budesonide is a
glucocorticoid with high topical activity, but low systemic bio-availability which results in reduced systemic effects in comparison with other
glucocorticoids. To date, it has been evaluated for use in patients with
inflammatory bowel disease when administered either orally as a controlled ileal release formulation or rectally as an
enema. In comparative trials, daily treatment with
budesonide enema 2 mg/100ml for 4 weeks produced endoscopic remission or improvement in 46 to 84% of patients with active distal
ulcerative colitis and/or
proctitis and histological remission or improvement in 45 to 68%. In general, this regimen was effective as regimens of
hydrocortisone,
methylprednisolone,
prednisolone or
mesalazine (5-amino-salicylic acid, mesalamine)
enemas, but caused less suppression of plasma
cortisol levels than the other
glucocorticoids. Oral treatment with controlled release
budesonide 9 mg/day for 8 weeks produces clinical remission in 42 to 67% of patients with active
Crohn's disease of the ileum, ileocaecal region and/or ascending colon and significantly reduces
Crohn's disease activity index scores compared with baseline and placebo. Results of a quality-of-life questionnaire reflected these clinical improvements.
Budesonide has similar efficacy to
prednisolone. Response to
budesonide is maintained after dosage tapering at 8 weeks. Compared with placebo, maintenance treatment with oral
budesonide 3 or 6 mg/day increases the duration of remission in patients with
Crohn's disease, but does not appear to affect the 1-year relapse rate. Thus,
budesonide, administered rectally to patients with distal
ulcerative colitis or
proctitis or orally to patients with
Crohn's disease of the ileum, ileocaecal region and/or ascending colon, is a favourable option for the treatment of acute exacerbations of
inflammatory bowel disease. Because of the low incidence of adverse
glucocorticoid-related effects associated with oral
budesonide, it may also be a useful agent for longer term maintenance
therapy if further clinical trials confirm its efficacy in this indication.