Table 2.
Response | Definition | ||
Complete | Either or both of the following: marked improvement of symptoms and return of serum AST or ALT, bilirubin and immunoglobulin values completely to normal within 1 year and sustained for at least a further 6 months on maintenance therapy, or liver biopsy specimen at some time during this period showing at most minimal activity. | or | Either or both of the following: marked improvement of symptoms together with at least 50% improvement of all liver tests during the first month of treatment, with AST or ALT levels continuing to fall to less than twice the upper normal limit within 6 months during any reductions toward maintenance therapy, or a liver biopsy within 1 year showing only minimal activity. |
Relapse | Either or both of the following: an increased in serum AST or ALT levels of greater than twice the upper normal limit or a liver biopsy showing active disease, with or without reappearance of symptoms, after a "complete" response as defined above. | or | Reappearance of symptoms of sufficient severity to require increased (or reintroduction of) immunosuppression, accompanied by any increase in serum AST or ALT levels, after a "complete" response as defined above. |
AST: aspartate aminotransferase, ALT: alanine aminotransferase.