Wiegand J et al. (2005) Budesonide in previously untreated autoimmune hepatitis. Liver Int 25: 927–934

Standard treatment for autoimmune hepatitis is >2 years' combination therapy with azathioprine and prednisolone. This is effective in inducing remission, but long-term prednisolone use is associated with side effects. Small studies of treatment with budesonide have indicated that it might have similar efficacy to, but fewer side effects than, conventional steroids. In this open, uncontrolled, multicenter phase IIa trial, Wiegand et al. showed that oral budesonide can effectively and safely induce remission in treatment naive patients with autoimmune hepatitis.

In all, 12 patients received a 3 mg capsule of budesonide three times daily for 3 months. Seven patients (58%) achieved complete remission, defined as a drop in levels of aspartate aminotransferase and alanine aminotransferase to ≤2× the upper limit of normal. Three patients (25%) had a partial response to treatment. Therapy was well tolerated in 10 cases. Three serious adverse events were observed, including one case of steroid-induced type 2 diabetes mellitus.

The goal of therapy for autoimmune hepatitis is cure or long-term control of symptoms via immunosuppression. Further studies are, therefore, needed to assess the long-term efficacy and tolerability of budesonide, and to compare budesonide therapy for autoimmune hepatitis directly with standard treatment. A larger, controlled, randomized, international study is ongoing, and is expected to address these issues.