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Quality of life and health-related utility analysis of adults with moderate and severe atopic dermatitis treated with tacrolimus ointment vs. topical corticosteroids.

Author(s): Poole CD, Chambers C, Allsopp R, Currie CJ

Affiliation(s): Department of Epidemiology, Pharmatelligence Ltd, Cardiff, UK.

Publication date & source: 2010-06, J Eur Acad Dermatol Venereol., 24(6):674-8.

Publication type: Research Support, Non-U.S. Gov't

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). CONCLUSION: 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.

Page last updated: 2010-10-05

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