Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group,Journal of Hepatology

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Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group
Journal of Hepatology ( IF 25.7 ) Pub Date : 2022-01-20 , DOI: 10.1016/j.jhep.2021.12.041
Simon Pape ₁ , Romée J A L M Snijders ₁ , Tom J G Gevers ₂ , Oliver Chazouilleres ₃ , George N Dalekos ₄ , Gideon M Hirschfield ₅ , Marco Lenzi ₆ , Michael Trauner ₇ , Michael P Manns ₈ , John M Vierling ₉ , Aldo J Montano-Loza ₁₀ , Ansgar W Lohse ₁₁ , Christoph Schramm ₁₂ , Joost P H Drenth ₁ , Michael A Heneghan ₁₃ ,

Affiliation

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; Division of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht 6229HX, The Netherlands; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Hepatology Department, Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, Saint-Antoine Hospital Assistance Publique-Hôpitaux de Paris, Paris, France; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Department of Medicine and Research Laboratory of Internal Medicine, University of Thessaly Medical School, Larissa, Greece.
Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Canada.
Department of Medical and Surgical Sciences, Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy.
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Departments of Medicine and Surgery, Baylor College of Medicine, Houston, TX, USA.
Division of Gastroenterology and Hepatology, University of Alberta Hospital, Edmonton, Canada.
1(st) Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
1(st) Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Martin Zeitz Centre for Rare Diseases, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).
Institute of Liver Studies, King's College Hospital, London, United Kingdom; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

Background & Aims

Autoimmune hepatitis (AIH) has been well characterised 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.

Methods

A systematic review was performed and a modified Delphi consensus process was used to identify and redefine the response criteria in autoimmune hepatitis.

Results

The consensus process initiated by the International Autoimmune Hepatitis Group proposes that the term ‘complete biochemical response’ defined as ‘normalization of serum transaminases and IgG below the upper limit of normal’ be adopted to include a time point at 6 months after initiation of treatment. An insufficient response by 6 months was a failure to meet the above definition. Non-response was defined as ‘<50% decrease of serum transaminases within 4 weeks after initiation of treatment’. 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 potential drug discontinuation’.

Conclusions

These definitions provide a simple and reproducible framework to define treatment response and non-response, irrespective of the therapeutic intervention. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable inter-study comparisons. 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. A consensus on endpoints is urgently required to set a global standard for the reporting of study results and to enable the comparison of results between clinical trials. Therefore, the International Autoimmune Hepatitis Group (IAIHG) herein presents a statement on 5 agreed response criteria and endpoints: complete biochemical response, insufficient response, non-response, remission, and intolerance to treatment, which can be used to guide future reporting.

中文翻译：

国际自身免疫性肝炎小组对自身免疫性肝炎反应标准和终点的系统评价

背景与目标

通过制定诊断标准，自身免疫性肝炎 (AIH) 已得到很好的表征和编纂。这些标准已经过改编和简化，并广泛用于临床实践。然而，需要更新和精确定义治疗反应和治疗的标准。

方法

进行了系统回顾，并使用修改后的德尔菲共识过程来确定和重新定义自身免疫性肝炎的反应标准。

结果

国际自身免疫性肝炎小组发起的共识进程建议采用术语“完全生化反应”定义为“血清转氨酶和 IgG 正常化低于正常上限”，以包括治疗开始后 6 个月的时间点。6 个月后反应不足是不符合上述定义。无反应定义为“治疗开始后 4 周内血清转氨酶降低 <50%”。缓解定义为肝脏组织学肝炎活动指数<4/18。对治疗的不耐受被认为代表“可能与导致潜在药物停药的治疗相关的任何不良事件”。