Cyclosporine Therapy for Autoimmune Hepatitis in Children

Abstract

Background: The current immunosuppressive treatment of patients with autoimmune hepatitis (AIH) consists of prednisolone and azathioprine. High doses of prednisolone used for disease remission are not universally effective and have serious adverse effects. Some authors have provided evidence of AIH therapy in children and adults with cyclosporine (Neoral) should corticosteroid therapy become ineffective. Preliminary results using cyclosporine in a small group of patients have shown that this drug appears to be a good substitute for corticosteroids. We performed this study to assess the efficacy and safety of cyclosporine in induction of remission in children with AIH.

 Materials and Methods: This was a case series, interventional clinical trial that involved children with AIH. twelve children with a median age of 9 years, 3 months who were diagnosed according to international criteria as having definite AIH were recruited. Cyclosporine alone was administered at a dosage of 3.5-5 mg/kg in 3 daily doses for 5 months, followed by low dose prednisolone (0.3 mg/kg/d) for one month, then followed by combined low doses of prednisolone and azathioprine (1.5 mg/kg/d in two doses). Patients discontinued cyclosporine after seven months. Biochemical remission of the disease was established by assessment of serum transaminase activity levels. Growth parameters that included Z-scores for height and weight, and adverse effects of the treatment were recorded.

 Results: Of the 10 remaining patients, 7 had normalized alanine aminotransferase (ALT) activity levels by 4 months and all patients had normalized ALT levels by 9 months of treatment. Adverse effects of cyclosporine were mild and disappeared during weaning off the medication.

 Conclusion: Cyclosporine induced biochemical remission of the hepati inflammatory/necrotic process in children with AIH. There were few, well-tolerated adverse effects. Longer follow-up of patients is necessary to establish possible long-term toxicity of cyclosporine .