Autoimmune hepatitis is a chronic liver disease that is effectively treated with immunosuppressive therapy.
Prednisolone, often in combination with azathioprine, is the basic therapeutic option to induce remission.
However, this regimen can cause numerous side effects.
Dr Michael Manns and colleagues evaluated budesonide in the induction of remission in patients with previously untreated autoimmune hepatitis.
|10 out of 12 individuals responded to therapy|
Between 1998 and 1999, the team treated 12 patients with 3 mg budesonide 3 times daily for 3 months in this open one-arm multicenter phase IIa study.
The primary end point included induction of remission indicated by a drop of aspartate aminotransferase.
A further primary endpoint evaluated by the investigators was alanine aminotransferase levels below 2 times the upper limit of normal.
The investigative team found that 7 of the 12 patients reached complete remission, and 3 patients had a partial response.
Therefore, the team noted that 10 out of 12 individuals responded to therapy.
The investigators observed that therapy was tolerated well in 10 out of 12 cases.
Dr Manns' team concluded, “Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment naïve patients with autoimmune hepatitis.”
“It should be further evaluated in prospective controlled trials and should be compared to prednisolone both in monotherapy and in combination with azathioprine.”