High discontinuation rate of azathioprine in autoimmune hepatitis, independent of time of treatment initiation.


Journal

Liver international : official journal of the International Association for the Study of the Liver
ISSN: 1478-3231
Titre abrégé: Liver Int
Pays: United States
ID NLM: 101160857

Informations de publication

Date de publication:
09 2020
Historique:
received: 06 03 2020
revised: 20 04 2020
accepted: 07 05 2020
pubmed: 16 5 2020
medline: 22 6 2021
entrez: 16 5 2020
Statut: ppublish

Résumé

Guidelines regarding treatment for autoimmune hepatitis (AIH) favour two strategies for azathioprine (AZA) introduction: concurrent with steroids at induction or delayed by 2-4 weeks. The safety and efficacy of both strategies have been unexplored. We established a cohort of 900 AIH patients from 12 centres in 7 European countries. There were 631 patients who used AZA as part of the therapeutic regimen. We distinguished two groups: patients with early AZA (<2 weeks) or delayed AZA initiation (≥2 weeks). Primary outcome was discontinuation of AZA in the first year of treatment. Cox regression and propensity score matching was performed to determine difference in outcomes between groups. Patients with early AZA initiation had significantly lower transaminases and bilirubin at baseline. Discontinuation rates of AZA did not differ between early and delayed starters (16.6% vs 14.2%), which did not reach statistical significance (hazard ratio 0.97, 95% confidence interval 0.61-1.55, P = .90). Stratification according to baseline disease activity or propensity score matching did not alter the results. Main reason for AZA discontinuation was intolerance to treatment (14.0% vs 13.2%, P = .78) with nausea and vomiting as main side effects. AIH remission rates were comparable among groups. The discontinuation rate of AZA in AIH treatment is ~15% in the first year of treatment. Early or delayed AZA initiation does not differ in remission and discontinuation rates in AIH induction therapy. Our data suggest that either strategy may be used as part of AIH treatment.

Sections du résumé

BACKGROUND
Guidelines regarding treatment for autoimmune hepatitis (AIH) favour two strategies for azathioprine (AZA) introduction: concurrent with steroids at induction or delayed by 2-4 weeks. The safety and efficacy of both strategies have been unexplored.
METHODS
We established a cohort of 900 AIH patients from 12 centres in 7 European countries. There were 631 patients who used AZA as part of the therapeutic regimen. We distinguished two groups: patients with early AZA (<2 weeks) or delayed AZA initiation (≥2 weeks). Primary outcome was discontinuation of AZA in the first year of treatment. Cox regression and propensity score matching was performed to determine difference in outcomes between groups.
RESULTS
Patients with early AZA initiation had significantly lower transaminases and bilirubin at baseline. Discontinuation rates of AZA did not differ between early and delayed starters (16.6% vs 14.2%), which did not reach statistical significance (hazard ratio 0.97, 95% confidence interval 0.61-1.55, P = .90). Stratification according to baseline disease activity or propensity score matching did not alter the results. Main reason for AZA discontinuation was intolerance to treatment (14.0% vs 13.2%, P = .78) with nausea and vomiting as main side effects. AIH remission rates were comparable among groups.
CONCLUSION
The discontinuation rate of AZA in AIH treatment is ~15% in the first year of treatment. Early or delayed AZA initiation does not differ in remission and discontinuation rates in AIH induction therapy. Our data suggest that either strategy may be used as part of AIH treatment.

Identifiants

pubmed: 32410363
doi: 10.1111/liv.14513
pmc: PMC7496382
doi:

Substances chimiques

Immunosuppressive Agents 0
Azathioprine MRK240IY2L

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

2164-2171

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

© 2020 The Authors. Liver International published by John Wiley & Sons Ltd.

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Auteurs

Simon Pape (S)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
European Reference Network RARE-LIVER, Hamburg, Germany.

Tom J G Gevers (TJG)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
European Reference Network RARE-LIVER, Hamburg, Germany.

Jan Maarten Vrolijk (JM)

Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands.

Bart van Hoek (B)

Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands.

Gerd Bouma (G)

Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands.

Carin M J van Nieuwkerk (CMJ)

Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands.

Richard Taubert (R)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
European Reference Network RARE-LIVER, Hamburg, Germany.

Elmar Jaeckel (E)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
European Reference Network RARE-LIVER, Hamburg, Germany.

Michael P Manns (MP)

Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.
European Reference Network RARE-LIVER, Hamburg, Germany.

Maria Papp (M)

Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.

Nora Sipeki (N)

Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary.

Felix Stickel (F)

Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich, Switzerland.

Cumali Efe (C)

Department of Gastroenterology, Harran University Hospital, Urfa, Turkey.

Ersan Ozaslan (E)

Department of Gastroenterology, Numune Research and Education Hospital, Ankara, Turkey.

Tugrul Purnak (T)

Department of Gastroenterology, Hacettepe University, Ankara, Turkey.

Frederik Nevens (F)

Department of Gastroenterology and Hepatology, University Hospital KU Leuven, Leuven, Belgium.
European Reference Network RARE-LIVER, Hamburg, Germany.

Dominik J N Kessener (DJN)

Department of Gastroenterology and Hepatology, University Clinic of Essen Duisburg, Essen, Germany.

Alisan Kahraman (A)

Department of Gastroenterology and Hepatology, University Clinic of Essen Duisburg, Essen, Germany.

Heiner Wedemeyer (H)

Department of Gastroenterology and Hepatology, University Clinic of Essen Duisburg, Essen, Germany.

Johannes Hartl (J)

1st Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
European Reference Network RARE-LIVER, Hamburg, Germany.

Christoph Schramm (C)

1st 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 RARE-LIVER, Hamburg, Germany.

Ansgar W Lohse (AW)

1st Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
European Reference Network RARE-LIVER, Hamburg, Germany.

Michael A Heneghan (MA)

Institute of Liver Studies, King's College Hospital, London, UK.
European Reference Network RARE-LIVER, Hamburg, Germany.

Joost P H Drenth (JPH)

Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
European Reference Network RARE-LIVER, Hamburg, Germany.

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