Budesonide could replace Prednisone for autoimmune hepatitisDr. Michael P. Manns and his colleagues said in an article appearing in the October issue of Gastroenterology that a combination of budesonide plus azathioprine achieves and maintains remission of autoimmune hepatitis as well as standard prednisone therapy does, while sparing patients many of the adverse effects of steroids.

Dr. Manns of Hannover (Germany) Medical School and his associates compared the safety and efficacy of the budesonide combination with the standard therapy of prednisone with azathioprine.

From Internalmedicinenews.com:

In the first phase of the study, 208 patients aged 10-70 years were randomly assigned to receive budesonide (103 subjects) or prednisone (105 subjects) with azathioprine for 6 months. Budesonide was given in 3-mg oral doses three times daily, a regimen that was decreased to twice daily if remission occurred. Prednisone was started at 40 mg/day and tapered to 10 mg/day.

Azathioprine was administered at a dose of 1-2 mg/kg per day, according to the clinician’s judgment. None of the study subjects had any evidence of cirrhosis.

A total of 176 subjects completed this phase. Reasons for withdrawal included lack of efficacy (3 patients taking budesonide and 12 taking prednisone), adverse events (3 patients taking budesonide, 3 taking prednisone), and lack of compliance with the study protocol (4 patients taking budesonide, 2 taking prednisone).

The study was described by researchers as the largest prospective, randomized, multicenter trial published to date for the treatment of autoimmune hepatitis.