Well-controlled autoimmune hepatitis treatment withdrawal may be safely accomplished without liver-biopsy guidance

BACKGROUND: Autoimmune hepatitis may flare up after treatment withdrawal, especially in those who had not achieved histological remission but had normal liver enzymes. The European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Disease (AASLD) Guidelines recommend performing liver biopsy before treatment withdrawal. The aim of the study is to define the outcome of treatment withdrawal in adults with well-controlled disease for 2 years with and without liver-biopsy guidance. METHODS: A retrospective observational study was conducted on biopsy-proven autoimmune hepatitis patients who were treated for 2 years and with persistently normal aspartate aminotransferase (AST) and alanine aminotransferase (ALT) or nearly so for 6 months prior to treatment withdrawal. Exclusions were: juvenile onset autoimmune hepatitis and prior treatment or use of agents other than corticosteroids and azathioprine. The primary endpoint was to define freedom from flare-ups for 1 year after treatment withdrawal. RESULTS: Thirty-four consecutive subjects meeting study criteria were identified. Treatment withdrawal was accomplished in 24 subjects without liver-biopsy guidance and 10 had pre-treatment withdrawal liver biopsy. Demographics, immunosuppressive usage, pre-treatment cirrhosis and pre-treatment liver enzymes were similar between the two groups, and 25% had an enzyme flare-up within 12 months after treatment withdrawal, which was similar in the two groups (20.8 vs 30.0%, P = 0.57). CONCLUSIONS: Adults with autoimmune hepatitis and excellent response to therapy for 2 years are candidates for treatment withdrawal without the need for liver biopsy.