title: Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis.
abstract: BACKGROUND
  Rational health care decision-making based on outcomes and economic evidence is essential to provide the best possible care for individual patients with atopic dermatitis (AD).
  
  
  OBJECTIVE
  To describe treatment outcomes and to evaluate resource utilization and associated cost of maintenance use of tacrolimus ointment (MU) vs. standard use of tacrolimus ointment (SU) in adults with AD.
  
  
  METHODS
  A pan-European, phase III multicentre randomized clinical trial was conducted. Patients with mild to severe AD were randomized to tacrolimus 0.1% ointment (MU) or vehicle (SU) twice per week for 12 months. Disease exacerbations were treated by using open-label tacrolimus 0.1% ointment twice daily. Resource utilization data were collected prospectively alongside the clinical trial. Costs of pooled resource data were determined using German unit cost data. Direct and indirect costs were considered from third party payer, patient and societal perspectives.
  
  
  RESULTS
  All patients with moderate and severe AD were included in a subanalysis, 75 patients in the MU arm (57% moderately affected) and 59 patients in the SU arm (59% moderately affected). In patients with moderate AD, the number of disease exacerbations in the MU arm was 2.4 vs. 5.5 in the SU arm (P<0.001); in patients with severe AD corresponding figures were 2.3 vs. 7.4 (P<0.001), respectively. Mean+/-SD total annual cost per patient was euro1525+/-1081 (MU) vs. euro1729+/-1209 (SU) in patients with moderate AD and euro2045+/-2013 (MU) vs. euro2904+/-1510 (SU) in patients with severe AD.
  
  
  CONCLUSIONS
  Maintenance treatment with 0.1% tacrolimus ointment is more effective and leads to cost savings and improved health-related quality of life in comparison with standard use of 0.1% tacrolimus ointment, especially in patients with severe AD.
authors.affiliation: Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität, Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Wollenberg
authors.forename: M K
authors.initials: MK
authors.lastname: Sidhu
authors.forename: I
authors.initials: I
authors.lastname: Odeyemi
authors.forename: B
authors.initials: B
authors.lastname: Dorsch
authors.forename: R
authors.initials: R
authors.lastname: Koehne-Volland
authors.forename: M
authors.initials: M
authors.lastname: Schaff
authors.forename: B
authors.initials: B
authors.lastname: Ehlken
authors.forename: K
authors.initials: K
authors.lastname: Berger
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D003876:Dermatitis, Atopic / Q000188:drug therapy* / Q000191:economics; D004334:Drug Administration Schedule; D005260:Female; D017048:Health Care Costs; D006304:Health Status; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics* / Q000627:therapeutic use; D008297:Male; D011788:Quality of Life; D016559:Tacrolimus / Q000191:economics* / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus