title: Efficacy and Limitations of Budesonide as a Second-Line Treatment for Patients With Autoimmune Hepatitis.
abstract: Many patients with autoimmune hepatitis (AIH) develop steroid-specific side effects or require doses of steroids that are unacceptable for long-term treatment. We investigated the efficacy of budesonide as an alternative steroid for patients previously treated with prednisolone who developed side effects or were unable to reduce their dose of prednisolone below acceptable levels. We also report the effects of more than 12 months of budesonide treatment in a large cohort of patients with AIH.
  
  
  
  We performed a retrospective analysis of data from 60 patients (51 female) with AIH who were treated initially with prednisolone (mean time, 47 mo) but then switched to budesonide, managed at a single center in Germany from 2001 through June 2016. Patients were evaluated after 6 months, 12 months, 24 months, 36 months, and at the last follow-up evaluation; response to treatment with budesonide was assessed based on normal serum levels of aminotransferases and IgG (biochemical response).
  
  
  
  Thirty patients were switched to budesonide therapy because of prednisolone-induced side effects and 30 patients switched because of prednisolone dependency. Overall, a biochemical response was detected in 55% of patients after 6 months of budesonide treatment, in 70% after 12 months, and in 67% after 24 months. At the last follow-up evaluation (mean time, 63 mo) 23 patients (38%) still were receiving budesonide treatment. Fifteen patients (25%) had switched back to prednisolone therapy because of insufficient response to budesonide or its side effects. Fifteen patients with osteopenia at the beginning of budesonide treatment were followed up and evaluated by dual-energy X-ray absorptiometry. After a median of 24 months of budesonide treatment, bone mineral density had improved in 6 patients, remained stable in 8 patients, and worsened in 1 patient.
  
  
  
  We performed a retrospective analysis of patients with AIH that confirmed the therapeutic value of budesonide beyond 12 months of treatment in patients who are intolerant to or dependent on prednisolone. Although budesonide-induced side effects appear to be mild in real life, effectiveness was limited in a considerable proportion of patients; close monitoring is advised.
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Moritz
authors.initials: M
authors.lastname: Peiseler
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Tina
authors.initials: T
authors.lastname: Liebscher
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Marcial
authors.initials: M
authors.lastname: Sebode
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Roman
authors.initials: R
authors.lastname: Zenouzi
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Hartl
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Hanno
authors.initials: H
authors.lastname: Ehlken
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Nadine
authors.initials: N
authors.lastname: Pannicke
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Weiler-Normann
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Ansgar W
authors.initials: AW
authors.lastname: Lohse
authors.affiliation: First Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address: cschramm@uke.de.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schramm
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001323:Autoantibodies / Q000097:blood; D015519:Bone Density; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005858:Germany; D019693:Hepatitis, Autoimmune / Q000188:drug therapy*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000637:Transaminases / Q000097:blood; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D001323:Autoantibodies; D007074:Immunoglobulin G; D019819:Budesonide; D000637:Transaminases
keywords: Autoimmune Liver Diseases; Bone Density; Second-Line Treatment; Steroid-Induced Side Effects