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

Pape, Simon and Gevers, Tom J. G. and Belias, Michail and Mustafajev, Ilyas F. and Vrolijk, Jan Maarten and van Hoek, Bart and Bouma, Gerd and van Nieuwkerk, Carin M. J. and Hartl, Johannes and Schramm, Christoph and Lohse, Ansgar W. and Taubert, Richard and Jaeckel, Elmar and Manns, Michael P. and Papp, Mária and Stickel, Felix and Heneghan, Michael A. and Drenth, Joost P. H. (2018) Predniso(lo)ne Dosage and Chance of Remission in Patients With Autoimmune Hepatitis. CLINICAL GASTROENTEROLOGY AND HEPATOLOGY. pp. 1-37. ISSN 1542-3565 (In Press)

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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.

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