Simon Pape1, Tom J G Gevers1, Michail Belias2, Ilyas F Mustafajev1, Jan Maarten Vrolijk3, Bart van Hoek4, Gerd Bouma5, Carin M J van Nieuwkerk5, Johannes Hartl5, Christoph Schramm6, Ansgar W Lohse7, Richard Taubert8, Elmar Jaeckel8, Michael P Manns8, Maria Papp9, Felix Stickel10, Michael A Heneghan11, Joost P H Drenth12. 1. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands. 2. Department for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands. 3. Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, The Netherlands. 4. Department of Gastroenterology and Hepatology, Leiden University Medical Center, Leiden, The Netherlands. 5. Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands. 6. 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. 7. 1(st) Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 8. Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany. 9. Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary. 10. Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich, Switzerland. 11. Institute of Liver Studies, King's College Hospital, London, United Kingdom. 12. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: joostphdrenth@cs.com.
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.
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.
Authors: Victoria Mary Gordon; Ratul Adhikary; Guruprasad P Aithal; Victoria Appleby; Debasish Das; James Day; Toby Delahooke; Selena Dixon; David Elphick; Claire Hardie; Michael Heneghan; Barbara Hoeroldt; Patricia Hooper; John Hutchinson; Rebecca L Jones; Faisal Khan; Jane Metcalf; Alick Nkhoma; Stavroula Pelitari; Martin Prince; Annell Prosser; Sushma Saksena; Vinay Sathyanarayana; Deven Vani; Andrew Yeoman; Dermot Gleeson Journal: Frontline Gastroenterol Date: 2021-05-18
Authors: Maaike Biewenga; Akin Inderson; Maarten E Tushuizen; A Stijn L P Crobach; Bart van Hoek Journal: Liver Transpl Date: 2020-10-27 Impact factor: 5.799