Budesonide in previously untreated autoimmune hepatitis

Johannes Wiegand; Andreas Schüler; Stephan Kanzler; Ansgar Lohse; Ulrich Beuers; Wolfgang Kreisel; Ulrich Spengler; Sibylle Koletzko; Peter L. M. Jansen; Günther Hochhaus; Helmut W. Möllmann; Markus Pröls; Michael P. Manns

doi:https://doi.org/10.1111/j.1478-3231.2005.01122.x

Budesonide in previously untreated autoimmune hepatitis

Johannes Wiegand, Andreas Schüler, Stephan Kanzler, Ansgar Lohse, Ulrich Beuers, Wolfgang Kreisel, Ulrich Spengler, Sibylle Koletzko, Peter L. M. Jansen, Günther Hochhaus, Helmut W. Möllmann, Markus Pröls, Michael P. Manns

Research output: Contribution to journal › Article › Academic › peer-review

94 Citations (Scopus)

Abstract

BACKGROUND: Autoimmune hepatitis (AIH) is a chronic liver disease that is effectively treated with immunosuppressive therapy. Predniso(lo)ne, often in combination with azathioprine, is the basic therapeutic option to induce remission. However, this regimen can cause numerous side effects. The aim of the present study was to evaluate budesonide as a treatment option in the induction of remission in patients with previously untreated AIH. METHODS: Between October 1998 and August 1999, 12 patients were treated with 3 mg budesonide thrice daily for 3 months in this open one-arm multicenter phase IIa study. Primary end point was induction of remission indicated by a drop of aspartate aminotransferase and alanine aminotransferase levels below two times the upper limit of normal. RESULTS: Seven of the 12 patients (58%) reached complete remission, three patients (25%) had a partial response. Thus, 10/12 individuals (83.3%) responded to therapy. Therapy was tolerated well in 10/12 cases (83.3%). CONCLUSIONS: Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment naïve patients with AIH. It should be further evaluated in prospective controlled trials and should be compared to predniso(lo)ne both in monotherapy and in combination with azathioprine

Original language	English
Pages (from-to)	927-934
Journal	Liver international
Volume	25
Issue number	5
DOIs	https://doi.org/10.1111/j.1478-3231.2005.01122.x
Publication status	Published - 2005

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https://doi.org/10.1111/j.1478-3231.2005.01122.x

Cite this

@article{c7f69266b71043388838fdb5891d8251,

title = "Budesonide in previously untreated autoimmune hepatitis",

abstract = "BACKGROUND: Autoimmune hepatitis (AIH) is a chronic liver disease that is effectively treated with immunosuppressive therapy. Predniso(lo)ne, often in combination with azathioprine, is the basic therapeutic option to induce remission. However, this regimen can cause numerous side effects. The aim of the present study was to evaluate budesonide as a treatment option in the induction of remission in patients with previously untreated AIH. METHODS: Between October 1998 and August 1999, 12 patients were treated with 3 mg budesonide thrice daily for 3 months in this open one-arm multicenter phase IIa study. Primary end point was induction of remission indicated by a drop of aspartate aminotransferase and alanine aminotransferase levels below two times the upper limit of normal. RESULTS: Seven of the 12 patients (58%) reached complete remission, three patients (25%) had a partial response. Thus, 10/12 individuals (83.3%) responded to therapy. Therapy was tolerated well in 10/12 cases (83.3%). CONCLUSIONS: Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment na{\"i}ve patients with AIH. It should be further evaluated in prospective controlled trials and should be compared to predniso(lo)ne both in monotherapy and in combination with azathioprine",

author = "Johannes Wiegand and Andreas Sch{\"u}ler and Stephan Kanzler and Ansgar Lohse and Ulrich Beuers and Wolfgang Kreisel and Ulrich Spengler and Sibylle Koletzko and Jansen, {Peter L. M.} and G{\"u}nther Hochhaus and M{\"o}llmann, {Helmut W.} and Markus Pr{\"o}ls and Manns, {Michael P.}",

year = "2005",

doi = "https://doi.org/10.1111/j.1478-3231.2005.01122.x",

language = "English",

volume = "25",

pages = "927--934",

journal = "Liver international",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

number = "5",

}

TY - JOUR

T1 - Budesonide in previously untreated autoimmune hepatitis

AU - Wiegand, Johannes

AU - Schüler, Andreas

AU - Kanzler, Stephan

AU - Lohse, Ansgar

AU - Beuers, Ulrich

AU - Kreisel, Wolfgang

AU - Spengler, Ulrich

AU - Koletzko, Sibylle

AU - Jansen, Peter L. M.

AU - Hochhaus, Günther

AU - Möllmann, Helmut W.

AU - Pröls, Markus

AU - Manns, Michael P.

PY - 2005

Y1 - 2005

N2 - BACKGROUND: Autoimmune hepatitis (AIH) is a chronic liver disease that is effectively treated with immunosuppressive therapy. Predniso(lo)ne, often in combination with azathioprine, is the basic therapeutic option to induce remission. However, this regimen can cause numerous side effects. The aim of the present study was to evaluate budesonide as a treatment option in the induction of remission in patients with previously untreated AIH. METHODS: Between October 1998 and August 1999, 12 patients were treated with 3 mg budesonide thrice daily for 3 months in this open one-arm multicenter phase IIa study. Primary end point was induction of remission indicated by a drop of aspartate aminotransferase and alanine aminotransferase levels below two times the upper limit of normal. RESULTS: Seven of the 12 patients (58%) reached complete remission, three patients (25%) had a partial response. Thus, 10/12 individuals (83.3%) responded to therapy. Therapy was tolerated well in 10/12 cases (83.3%). CONCLUSIONS: Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment naïve patients with AIH. It should be further evaluated in prospective controlled trials and should be compared to predniso(lo)ne both in monotherapy and in combination with azathioprine

AB - BACKGROUND: Autoimmune hepatitis (AIH) is a chronic liver disease that is effectively treated with immunosuppressive therapy. Predniso(lo)ne, often in combination with azathioprine, is the basic therapeutic option to induce remission. However, this regimen can cause numerous side effects. The aim of the present study was to evaluate budesonide as a treatment option in the induction of remission in patients with previously untreated AIH. METHODS: Between October 1998 and August 1999, 12 patients were treated with 3 mg budesonide thrice daily for 3 months in this open one-arm multicenter phase IIa study. Primary end point was induction of remission indicated by a drop of aspartate aminotransferase and alanine aminotransferase levels below two times the upper limit of normal. RESULTS: Seven of the 12 patients (58%) reached complete remission, three patients (25%) had a partial response. Thus, 10/12 individuals (83.3%) responded to therapy. Therapy was tolerated well in 10/12 cases (83.3%). CONCLUSIONS: Budesonide monotherapy was effective in the induction of remission and well tolerated in treatment naïve patients with AIH. It should be further evaluated in prospective controlled trials and should be compared to predniso(lo)ne both in monotherapy and in combination with azathioprine

U2 - https://doi.org/10.1111/j.1478-3231.2005.01122.x

DO - https://doi.org/10.1111/j.1478-3231.2005.01122.x

M3 - Article

C2 - 16162148

SN - 1478-3223

VL - 25

SP - 927

EP - 934

JO - Liver international

JF - Liver international

IS - 5

ER -