Liver fibrosis may reduce the efficacy of budesonide in the treatment of autoimmune hepatitis and overlap syndrome

Autoimmun Rev. 2012 Mar;11(5):330-4. doi: 10.1016/j.autrev.2011.09.006. Epub 2011 Oct 6.


Background and aim: The aim of the present study was to assess the efficacy and tolerability of budesonide as an alternative first line treatment option for autoimmune hepatitis (AIH) and the overlap syndrome.

Methods: A total of 18 AIH or overlap syndrome patients were evaluated. Outcomes of treatment by the end of the study were defined as treatment failure, partial response, complete response and remission.

Results: Complete response and remission were achieved in 61.1% (11/18) of patients, while 38.9% (7/18) of patients were considered treatment failures. Liver fibrosis was observed in 55.5% of patients' biopsies. More patients with liver fibrosis failed to respond to treatment compared to patients without fibrosis, a difference bordering on statistical significance (60% vs. 12.5%; p=0.066). Although statistically insignificant, the presence of at least one side effect was observed more frequently in patients with fibrosis compared to those without fibrosis (80% vs. 37.5%; p=0.145). Overall, side effects occurred significantly more commonly in non-responders than responders (100% vs. 36%; p=0.013).

Conclusions: Budesonide is an effective treatment option for the management of AIH, with a low incidence of side effects in patients without findings of advanced liver disease. The presence of liver fibrosis may increase the likelihood of treatment failure as well as the risk of developing side effects. Our study findings suggest that budesonide may be effective in a select group of AIH patients. Further studies are needed to determine its exact place for the treatment of AIH and overlap syndrome.

Publication types

  • Review

MeSH terms

  • Adult
  • Aged
  • Budesonide / adverse effects
  • Budesonide / therapeutic use*
  • Female
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use*
  • Hepatitis, Autoimmune / complications
  • Hepatitis, Autoimmune / drug therapy*
  • Hepatitis, Autoimmune / pathology*
  • Humans
  • Liver Cirrhosis / pathology*
  • Male
  • Middle Aged
  • Treatment Outcome
  • Young Adult


  • Glucocorticoids
  • Budesonide