Budesonide for the treatment of autoimmune hepatitis

To evaluate the use of budesonide for the treatment of autoimmune hepatitis (AIH).

Literature was accessed through PubMed/MEDLINE (1966-June 2011) and Web of Science (1965-June 2011) using the terms autoimmune hepatitis and budesonide. Literature was limited to English-language publications. In addition, references from publications identified were reviewed.

All articles in English identified from the data sources were evaluated.

The initial treatment of choice for AIH is prednisone alone or with azathioprine. However, a significant number of patients do not respond adequately or have adverse reactions to this regimen; therefore, alternative treatments are required. Budesonide is an orally administered synthetic corticosteroid with high affinity for the glucocorticoid receptor that undergoes extensive first-pass metabolism. It has Food and Drug Administration-approved labeling for the treatment and maintenance of remission of mild-to-moderate Crohn disease involving the ileum and/or ascending colon. One prospective, active-controlled study of budesonide in the treatment of AIH was identified, as well as 5 small open-label studies and 1 retrospective chart review. Budesonide appears to have efficacy in the treatment of AIH, including in patients intolerant to standard therapy with prednisone alone or with azathioprine, with a reduced incidence of corticosteroid-related adverse reactions. However, in patients with AIH and cirrhosis, the efficacy of budesonide may be reduced and the incidence of corticosteroid-related adverse reactions may be increased.

Budesonide may be an additional treatment option for patients with AIH but without cirrhosis who are intolerant to standard therapy with prednisone or prednisone with azathioprine.