LAUSR

Autoimmune hepatitis (AIH) has been well characterized and codified through the development of diagnostic criteria. These criteria have been adapted and simplified and are widely used in clinical practice. However, there is a need to update and precisely define the criteria for both treatment response and treatment. We performed a systematic review and used the Delphi method to identify and redefine the response criteria in AIH. The consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term 'complete biochemical response' be adopted to include a time point at six months after initiation of treatment. An insufficient response by six months was a failure to meet the above definition. Non-response was defined as a 50% reduction, or less, in transaminase activity within four weeks of treatment initiation. Remission is defined as liver histology with a Hepatitis Activity Index <4/18. Intolerance to treatment was agreed to stand for 'any adverse event possibly related to treatment leading to drug discontinuation'. These definitions provide a simple and reproducible framework for treatment response and non-response, irrespective of the therapeutic intervention. The need for consensus about endpoints is pertinent and urgently required to set a general standard for the reporting of study results and for allowing comparisons of the results in future clinical trials. Future prospective database studies are needed to validate these endpoints. LAY SUMMARY: Consensus among international experts on response criteria and endpoints in autoimmune hepatitis is lacking. The need for agreed endpoints is urgently required to set a general standard for reporting study results and make results comparable in future clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) here presents a statement on five agreed response criteria and endpoints: complete biochemical response, insufficient response, non-response, remission, and intolerance to treatment.