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

Hepatitis, Autoimmune / diagnosis Humans Prospective Studies Transaminases
autoimmune hepatitis complete biochemical response endpoints insufficient response intolerance non-response remission

Journal

Journal of hepatology
ISSN: 1600-0641
Titre abrégé: J Hepatol
Pays: Netherlands
ID NLM: 8503886

Informations de publication

Date de publication:
Apr 2022
Historique:
received: 09 04 2021
revised: 18 11 2021
accepted: 11 12 2021
pubmed: 24 1 2022
medline: 26 4 2022
entrez: 23 1 2022
Statut: ppublish

Résumé

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

Sections du résumé

BACKGROUND & AIMS OBJECTIVE
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 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 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 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 BACKGROUND
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.

Identifiants

DOI: 10.1016/j.jhep.2021.12.041 PMID: 35066089
pubmed: 35066089
pii: S0168-8278(22)00012-5
doi: 10.1016/j.jhep.2021.12.041
pii:
doi:

Substances chimiques

Transaminases EC 2.6.1.-

Types de publication

Journal Article Research Support, Non-U.S. Gov't Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

841-849

Investigateurs

P Almasio (P)
F Alvarez (F)
R Andrade (R)
C Arikan (C)
D Assis (D)
E Bardou-Jacquet (E)
M Biewenga (M)
E Cancado (E)
N Cazzagon (N)
O Chazouillères (O)
G Colloredo (G)
M Cuarterolo (M)
G Dalekos (G)
D Debray (D)
M Robles-Díaz (M)
J Drenth (J)
J Dyson (J)
C Efe (C)
B Engel (B)
S Ferri (S)
R Fontana (R)
N Gatselis (N)
A Gerussi (A)
E Halilbasic (E)
N Halliday (N)
M Heneghan (M)
G Hirschfield (G)
B van Hoek (B)
M Hørby Jørgensen (M)
G Indolfini (G)
R Iorio (R)
S Jeong (S)
D Jones (D)
D Kelly (D)
N Kerkar (N)
F Lacaille (F)
C Lammert (C)
B Leggett (B)
M Lenzi (M)
C Levy (C)
R Liberal (R)
A Lleo (A)
A Lohse (A)
S Ines Lopez (S)
E de Martin (E)
V McLin (V)
G Mieli-Vergani (G)
P Milkiewicz (P)
N Mohan (N)
L Muratori (L)
G Nebbia (G)
C van Nieuwkerk (C)
Y Oo (Y)
A Ortega (A)
A Páres (A)
T Pop (T)
D Pratt (D)
T Purnak (T)
G Ranucci (G)
S Rushbrook (S)
C Schramm (C)
A Stättermayer (A)
M Swain (M)
A Tanaka (A)
R Taubert (R)
D Terrabuio (D)
B Terziroli (B)
M Trauner (M)
P Valentino (P)
F van den Brand (F)
A Villamil (A)
S Wahlin (S)
H Ytting (H)
K Zachou (K)
M Zeniya (M)

Commentaires et corrections

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Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest All authors report no potential conflicts that are relevant to the manuscript. Please refer to the accompanying ICMJE disclosure forms for further details.

Auteurs

Simon Pape (S)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

Romée J A L M Snijders (RJALM)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

Tom J G Gevers (TJG)

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).

Oliver Chazouilleres (O)

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).

George N Dalekos (GN)

Department of Medicine and Research Laboratory of Internal Medicine, University of Thessaly Medical School, Larissa, Greece.

Gideon M Hirschfield (GM)

Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Canada.

Marco Lenzi (M)

Department of Medical and Surgical Sciences, Sant'Orsola-Malpighi, University of Bologna, Bologna, Italy.

Michael Trauner (M)

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).

Michael P Manns (MP)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

John M Vierling (JM)

Departments of Medicine and Surgery, Baylor College of Medicine, Houston, TX, USA.

Aldo J Montano-Loza (AJ)

Division of Gastroenterology and Hepatology, University of Alberta Hospital, Edmonton, Canada.

Ansgar W Lohse (AW)

1(st) Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

Christoph Schramm (C)

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).

Joost P H Drenth (JPH)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; European Reference Network on Hepatological Diseases (ERN RARE-LIVER).

Michael A Heneghan (MA)

Institute of Liver Studies, King's College Hospital, London, United Kingdom; European Reference Network on Hepatological Diseases (ERN RARE-LIVER). Electronic address: michael.heneghan@nhs.net.

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Classifications MeSH

questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Hépatite auto-immune › Systematic review of response criteria and...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Systematic review of response criteria and...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › Systematic review of response criteria and...
questionsmedicales.fr › Enzymes et coenzymes › Enzymes › Transferases › Nitrogenous group transferases › Transaminases › Systematic review of response criteria and...