Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis

Simon Pape, Tom J.G. Gevers, Michail Belias, Ilyas F. Mustafajev, Jan Maarten Vrolijk, Bart van Hoek, Gerd Bouma, Carin M.J. van Nieuwkerk, Johannes Hartl, Christoph Schramm, Ansgar W. Lohse, Richard Taubert, Elmar Jaeckel, Michael P. Manns, M. Papp, Felix Stickel, Michael A. Heneghan, Joost P.H. Drenth

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background & Aims: Patients with autoimmune hepatitis (AIH) commonly receive induction therapy with predniso(lo)ne followed by maintenance therapy with azathioprine. European Association for Study of the Liver clinical practice guidelines advise a predniso(lo)ne dose range of 0.50–1 mg/kg/day, which leaves room for practice variation. We performed a multicenter study to determine the efficacy of different dose ranges of predniso(lo)ne induction therapy in a large European cohort of patients with AIH. Methods: We performed a retrospective cohort study using a comparative effectiveness design. We collected data from 451 adults with AIH who began treatment from 1978 through 2017 at 9 centers in 5 European countries. We assigned patients to a high-dose group (initial predniso(lo)ne dose ≥0.50 mg/kg/day; n = 281) or a low-dose group (<0.50 mg/kg/day; n = 170). Logistic regression was performed to determine difference in outcomes between the groups. The primary outcome was normal serum levels of transaminases at 6 months after initiation of therapy. Results: There was no significant difference in rates of normalization of transaminases between the high-dose predniso(lo)ne group and the low-dose group (70.5% vs 64.7%; P =.20). After multivariable logistic regression with correction for confounders, there was no difference in the likelihood of normalization of transaminases between the groups (odds ratio, 1.21; 95% CI, 0.78–1.87; P =.38). Patients given an initial high dose of predniso(lo)ne received more predniso(lo)ne over time than patients started on a lower dose (median doses over 6 months: 3780 mg vs 2573 mg) (P <.01). Conclusions: In a retrospective study of patients with AIH in Europe, we found that the dose of predniso(lo)ne to induce remission in patients with AIH is less relevant than assumed. An initial predniso(lo)ne dose below 0.50 mg/kg/day substantially decreases unnecessary exposure to predniso(lo)ne in patients with AIH.

Original languageEnglish
Pages (from-to)2068-2075.e2
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number10
DOIs
Publication statusPublished - Sep 1 2019

Fingerprint

Autoimmune Hepatitis
Transaminases
Retrospective Studies
Logistic Models
Therapeutics
Azathioprine
Practice Guidelines
Multicenter Studies
Cohort Studies
Odds Ratio
Liver

Keywords

  • ALT
  • AST
  • Cirrhosis
  • Corticosteroid
  • EASL Guidelines
  • IgG
  • Induction Therapy
  • Prednisolone
  • Prednisone

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Pape, S., Gevers, T. J. G., Belias, M., Mustafajev, I. F., Vrolijk, J. M., van Hoek, B., ... Drenth, J. P. H. (2019). Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis. Clinical Gastroenterology and Hepatology, 17(10), 2068-2075.e2. https://doi.org/10.1016/j.cgh.2018.12.035

Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis. / Pape, Simon; Gevers, Tom J.G.; Belias, Michail; Mustafajev, Ilyas F.; Vrolijk, Jan Maarten; van Hoek, Bart; Bouma, Gerd; van Nieuwkerk, Carin M.J.; Hartl, Johannes; Schramm, Christoph; Lohse, Ansgar W.; Taubert, Richard; Jaeckel, Elmar; Manns, Michael P.; Papp, M.; Stickel, Felix; Heneghan, Michael A.; Drenth, Joost P.H.

In: Clinical Gastroenterology and Hepatology, Vol. 17, No. 10, 01.09.2019, p. 2068-2075.e2.

Research output: Contribution to journalArticle

Pape, S, Gevers, TJG, Belias, M, Mustafajev, IF, Vrolijk, JM, van Hoek, B, Bouma, G, van Nieuwkerk, CMJ, Hartl, J, Schramm, C, Lohse, AW, Taubert, R, Jaeckel, E, Manns, MP, Papp, M, Stickel, F, Heneghan, MA & Drenth, JPH 2019, 'Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis', Clinical Gastroenterology and Hepatology, vol. 17, no. 10, pp. 2068-2075.e2. https://doi.org/10.1016/j.cgh.2018.12.035
Pape S, Gevers TJG, Belias M, Mustafajev IF, Vrolijk JM, van Hoek B et al. Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis. Clinical Gastroenterology and Hepatology. 2019 Sep 1;17(10):2068-2075.e2. https://doi.org/10.1016/j.cgh.2018.12.035
Pape, Simon ; Gevers, Tom J.G. ; Belias, Michail ; Mustafajev, Ilyas F. ; Vrolijk, Jan Maarten ; van Hoek, Bart ; Bouma, Gerd ; van Nieuwkerk, Carin M.J. ; Hartl, Johannes ; Schramm, Christoph ; Lohse, Ansgar W. ; Taubert, Richard ; Jaeckel, Elmar ; Manns, Michael P. ; Papp, M. ; Stickel, Felix ; Heneghan, Michael A. ; Drenth, Joost P.H. / Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis. In: Clinical Gastroenterology and Hepatology. 2019 ; Vol. 17, No. 10. pp. 2068-2075.e2.
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AU - Pape, Simon

AU - Gevers, Tom J.G.

AU - Belias, Michail

AU - Mustafajev, Ilyas F.

AU - Vrolijk, Jan Maarten

AU - van Hoek, Bart

AU - Bouma, Gerd

AU - van Nieuwkerk, Carin M.J.

AU - Hartl, Johannes

AU - Schramm, Christoph

AU - Lohse, Ansgar W.

AU - Taubert, Richard

AU - Jaeckel, Elmar

AU - Manns, Michael P.

AU - Papp, M.

AU - Stickel, Felix

AU - Heneghan, Michael A.

AU - Drenth, Joost P.H.

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N2 - Background & Aims: Patients with autoimmune hepatitis (AIH) commonly receive induction therapy with predniso(lo)ne followed by maintenance therapy with azathioprine. European Association for Study of the Liver clinical practice guidelines advise a predniso(lo)ne dose range of 0.50–1 mg/kg/day, which leaves room for practice variation. We performed a multicenter study to determine the efficacy of different dose ranges of predniso(lo)ne induction therapy in a large European cohort of patients with AIH. Methods: We performed a retrospective cohort study using a comparative effectiveness design. We collected data from 451 adults with AIH who began treatment from 1978 through 2017 at 9 centers in 5 European countries. We assigned patients to a high-dose group (initial predniso(lo)ne dose ≥0.50 mg/kg/day; n = 281) or a low-dose group (<0.50 mg/kg/day; n = 170). Logistic regression was performed to determine difference in outcomes between the groups. The primary outcome was normal serum levels of transaminases at 6 months after initiation of therapy. Results: There was no significant difference in rates of normalization of transaminases between the high-dose predniso(lo)ne group and the low-dose group (70.5% vs 64.7%; P =.20). After multivariable logistic regression with correction for confounders, there was no difference in the likelihood of normalization of transaminases between the groups (odds ratio, 1.21; 95% CI, 0.78–1.87; P =.38). Patients given an initial high dose of predniso(lo)ne received more predniso(lo)ne over time than patients started on a lower dose (median doses over 6 months: 3780 mg vs 2573 mg) (P <.01). Conclusions: In a retrospective study of patients with AIH in Europe, we found that the dose of predniso(lo)ne to induce remission in patients with AIH is less relevant than assumed. An initial predniso(lo)ne dose below 0.50 mg/kg/day substantially decreases unnecessary exposure to predniso(lo)ne in patients with AIH.

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KW - AST

KW - Cirrhosis

KW - Corticosteroid

KW - EASL Guidelines

KW - IgG

KW - Induction Therapy

KW - Prednisolone

KW - Prednisone

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