Abstract
Background/Aims: The current immunosuppressive treatment of patients with autoimmune 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 therapy, we proposed to treat patients with oral cyclosporine to obtain
the remission of the inflammatory process.
Methods: This is a pilot, multinational, multicenter, clinical trial involving 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, followed by combined low doses of prednisone and azathioprine
for 1 month, after which cyclosporine was discontinued. Biochemical remission of the
disease 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Results: Two patients were withdrawn from the study: one for non-compliance and the other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. Of the 30 remaining patients,
25 normalized alanine aminotransferase activity 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 effects of cyclosporine weremild and disappeared during weaning
off the medication.
Conclusions: Cyclosporine induced the biochemical remission of the hepatic inflammatory/necrotic
process in children with autoimmune hepatitis, with few and well-tolerated adverse
effects.
Keywords
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Article info
Publication history
Accepted:
September 14,
1998
Received in revised form:
September 7,
1998
Received:
June 15,
1998
Identification
Copyright
© 1999 Published by Elsevier Inc.
