Short-term cyclosporine induces a remission of autoimmune hepatitis in children

Background/Aims: The current immunosuppressive treatment of patients with a utoimmune hepatitis consists of prednisone and azathioprine, High doses of prednisone used to obtain the remission of the disease are associated with serious adverse effects, To avoid harmful consequences of prednisone therap y, we proposed to treat patients with oral cyclosporine to obtain the remis sion of the inflammatory process. Methods: This is a pilot, multinational, multicenter, clinical trial involv ing children with autoimmune hepatitis. Thirty-two children were recruited, who according to international criteria were considered as having definite autoimmune hepatitis. Cyclosporine alone was administered for 6 months, fo llowed by combined low doses of prednisone and azathioprine for 1 month, af ter which cyclosporine was discontinued. Biochemical remission of the disea se was established by the follow-up of serum transaminase activity levels. Growth parameters and adverse effects of the treatment were recorded. Results: Two patients were withdrawn from the study: one for non-compliance and the other for liver failure which did not improve with cyclosporine. O f the 30 remaining patients, 25 normalized alanine aminotransferase activit y levels by 6 months and all the patients by 1 year of treatment. Z-scores for height showed a trend towards improvement during treatment. Adverse eff ects of cyclosporine tr ere mild and disappeared during weaning off the med ication. Conclusions: Cyclosporine induced the biochemical remission of the hepatic inflammatory/necrotic process in children with autoimmune hepatitis, with f ew and well-tolerated adverse effects.