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Health-related utility among adults with atopic dermatitis treated with 0.1% tacrolimus ointment as maintenance therapy over the long term: findings from the Protopic CONTROL study.

Author(s): Poole CD, Chambers C, Sidhu MK, Currie CJ

Affiliation(s): Pharmatelligence Ltd, Cardiff, U.K.

Publication date & source: 2009-12, Br J Dermatol., 161(6):1335-40. Epub 2009 Jul 1.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Long-term maintenance treatment with 0.1% tacrolimus ointment for the prevention of flares has been demonstrated to be well tolerated and effective in adults for the treatment of atopic dermatitis (AD) but its impact on health-related utility has not been reported. OBJECTIVES: The purpose of this study was to estimate utility changes associated with the use of tacrolimus ointment in the maintenance treatment of adults with AD. METHODS: Data were collected from a clinical trial investigating long-term maintenance treatment with 0.1% tacrolimus ointment in adults with AD. All patients were treated with twice-daily tacrolimus ointment during an open-label period (OLP) of up to 6 weeks, with subsequent randomization to a double-blind disease-control period (DCP) of 12 months comparing tacrolimus ointment, used twice weekly as maintenance treatment, vs. the emollient vehicle as standard treatment. Health-related utility (EQ-5D(index)) was estimated by Monte Carlo simulation from SF-12 responses by application of a published response mapping algorithm and the U.K. tariff for EQ-5D responses and SF-6D responses, respectively. RESULTS: Evaluable data were available for 257 patients stratified into mild, moderate or severe AD with a median age at screening of 28 years [interquartile range (IQR) 22-38] and 40% male. At screening the median EQ-5D(index) across the strata was 0.848 units (IQR 0.704-0.882) for mild cases, 0.796 (0.737-0.876) for moderate cases, and 0.760 (0.661-0.823, P < 0.001) for those with severe disease. At the end of the OLP, mean utility improvement across all strata was 0.027 [95% confidence interval (CI) -0.011 to 0.065, P = 0.165] for mild cases, 0.046 (95% CI 0.015-0.064, P = 0.002) for moderate cases and 0.076 (95% CI 0.035-0.118, P < 0.001) for those with severe disease. At the end of the blinded DCP, repeated measures analysis showed an age- and sex-adjusted mean change of 0.045 units (P < 0.001) for subjects treated with tacrolimus ointment over those treated with emollient vehicle. CONCLUSIONS: Patients with AD of all severities showed considerable decrements in health-related utility. However, treatment with 0.1% tacrolimus ointment was associated with clinically significant improvement in health-related utility for patients with moderate and severe AD, which was sustained over a 12-month maintenance period compared with those using standard treatment with an emollient vehicle.

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