title: Quality of life and health-related utility analysis of adults with moderate and severe atopic dermatitis treated with tacrolimus ointment vs. topical corticosteroids.
abstract: BACKGROUND
  The purpose of this study was to measure change in quality of life (QoL) and estimate health-related utility in adults with moderate and severe atopic dermatitis (AD) following the use of either tacrolimus ointment or topical corticosteroids.
  
  
  METHODS
  Data were analysed from a double-blind, randomized controlled trial comparing the treatment of adults with moderate and severe AD with either tacrolimus ointment or a standard corticosteroid regimen. Following randomisation, patients applied their medication twice-daily for 6 months. Monthly assessments determined response and QoL. Health-related utility (EQ5Dindex) was estimated by Monte Carlo simulation from SF-12 responses via a published mapping algorithm.
  
  
  RESULTS
  At baseline, estimated utility data were available for 926 (95%) of the intention-to-treat patients, 57% of whom had AD of moderate severity (43% severe). The mean age at baseline was 32.5 years (SD +/- 11.8), 46.2% were male, with a mean EQ5Dindex for moderate cases of 0.770 (SD +/- 0.157), and 0.665 (SD +/- 0.225) for those with severe disease (P < 0.001). Patients treated with tacrolimus ointment showed significantly greater improvement in all but one domain of the SF-36. At baseline, there was no difference in estimated utility between the two groups; however, a difference in utility in favour of tacrolimus ointment emerged after 1 month's treatment (0.849 vs. 0.820; P = 0.004). Over the 6-month study period, the mean, marginal utility difference between the study arms was 0.032 U (utility) in favour of tacrolimus (P < 0.001).
  
  
  CONCLUSIONS
  Treatment with 0.1% tacrolimus ointment rather than a standard topical corticosteroid ointment regimen was associated with clinically significant, incremental improvement in QoL, sustained over a 6-month period. A within-trial cost-utility estimate based on study medication cost alone suggests that tacrolimus ointment is highly cost-effective given existing willingness-to-pay thresholds.
authors.affiliation: Department of Epidemiology, Pharmatelligence Ltd, Cardiff, UK.
authors.forename: C D
authors.initials: CD
authors.lastname: Poole
authors.forename: C
authors.initials: C
authors.lastname: Chambers
authors.forename: R
authors.initials: R
authors.lastname: Allsopp
authors.forename: C J
authors.initials: CJ
authors.lastname: Currie
mesh_terms: D000287:Administration, Topical; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D000328:Adult; D003362:Cost-Benefit Analysis; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D017723:Drug Utilization Review / Q000379:methods*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D008297:Male; D009824:Ointments; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012720:Severity of Illness Index; D016559:Tacrolimus / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D009824:Ointments; D016559:Tacrolimus