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

DATA SOURCES: 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.

STUDY SELECTION AND DATA EXTRACTION: All articles in English identified from the data sources were evaluated.

DATA SYNTHESIS: 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.

CONCLUSIONS: 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.