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

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-5Dindex) 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-5Dindex 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.