Published online Mar 7, 2006. doi: 10.3748/wjg.v12.i9.1362
Revised: July 1, 2005
Accepted: August 26, 2005
Published online: March 7, 2006
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 alternative. 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®) 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.