Endpoints for Autoimmune Hepatitis Treatment as Proposed after a Consensus Process by the International Autoimmune Hepatitis Working Group
Endpoint | Definition |
---|---|
Complete biochemical response | Normalization of serum transaminases and IgG below the ULN within 6 months of treatment |
Insufficient response | Lack of complete biochemical response. Should be determined no later than 6 months after initiation of treatment |
Non-response | <50% decrease of serum transaminases within 4 weeks after initiation of treatment |
Remission | Hepatitis activity index <4 |
Intolerance to treatment | Any adverse event possibly related to treatment as assessed by the treating physician leading to potential discontinuation of the drug |
IgG, immunoglobulin G; ULN, upper limit of normal range.