AIM: Prednisone and azathioprine represent the standard treatment for autoimmune hepatitis (AIH). However, only 65% of the patients enter complete histological remission. Recently, budesonide (BUD) was reported to be a promising altative. In this study we assessed the efficacy and safety of BUD in AIH.METHODS: Eighteen patients (12 women, 6 men; mean age 45.4±21 years) with AIH were treated with BUD (Budenofalk(R)) 3 mg thrice daily and followed up for at least 24 wk. Seven patients also had features of primary biliary cirrhosis (n = 5) or primary sclerosing cholangitis (n = 2). Advanced liver fibrosis or cirrhosis was present in 6 patients.RESULTS: Fifteen (83%) patients had a complete clinical and biochemical remission. Ten patients, including five with acute hepatitis, were given BUD as first-line therapy, of which seven enter remission. Three patients,two with liver cirrhosis, did not improve. All patients with second-line therapy experienced long-term remission.A histological remission was also seen in three patients.Clinically relevant BUD-induced side effects were recorded only in patients with liver cirrhosis (n = 4).CONCLUSION: BUD is effective in remission induction in the majority of our patients with AIH. Side effects and treatment failure was mainly observed in patients with liver cirrhosis.