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 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.
authors.affiliation: Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625 Hannover, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Wiegand
authors.forename: Andreas
authors.initials: A
authors.lastname: Schüler
authors.forename: Stephan
authors.initials: S
authors.lastname: Kanzler
authors.forename: Ansgar
authors.initials: A
authors.lastname: Lohse
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beuers
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kreisel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Spengler
authors.forename: Sibylle
authors.initials: S
authors.lastname: Koletzko
authors.forename: Peter L M
authors.initials: PL
authors.lastname: Jansen
authors.forename: Günther
authors.initials: G
authors.lastname: Hochhaus
authors.forename: Helmut W
authors.initials: HW
authors.lastname: Möllmann
authors.forename: Markus
authors.initials: M
authors.lastname: Pröls
authors.forename: Michael P
authors.initials: MP
authors.lastname: Manns
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D019819:Budesonide / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D005260:Female; D019693:Hepatitis, Autoimmune / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D019819:Budesonide; D000410:Alanine Transaminase