Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine Versus Cyclosporine: A Randomized Trial.

Abstract

The aim of this study was to find the outcome and adverse effects of 2 initial treatments in children with autoimmune hepatitis, prednisone (PRED) plus azathioprine (AZA) versus cyclosporine (CsA). Between December 2008 and February 2012, 50 consecutive patients were centrally randomized to 1 of 2 treatment arms. Group 1: PRED was indicated at a dose of 1 to 2 mg · kg · day (up to 60 mg/day) and AZA at a dose of 1 to 2 mg · kg · day. Group 2: CsA was administered at a dose of 4 mg · kg · day orally divided into 2 doses. After remission, all patients were given a combination of PRED at 0.3 to 0.5 mg · kg · day and AZA at 1 to 2 mg · kg · day. Children presenting liver failure were placed on a triple immunosuppressive regimen if this condition persisted after 1 week of treatment, after liver function normalization they were switched back to their initial scheme. A total of 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 versus CsA: 13.6 weeks (P < 0.0081). All children recovered liver function in a mean time of 32 ± 26 days. Cushingoid syndrome was more frequently observed with PRED-AZA (P < 0.001) and gingival hypertrophy with CsA (P < 0.001). A significant increase in body mass index was observed in all patients from initial treatment to remission, being greater with PRED-AZA. Similar outcomes were obtained with PRED plus AZA or CsA treatments. Either therapeutic strategy could be used according to the particular characteristics of each patient. Triple immunosuppression was beneficial in patients with liver failure at onset.