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Twice-weekly treatment with tacrolimus in pediatric atopic dermatitis: Efficacy and economic impact over 1 year

A 12-month Pan-European, phase III, multicenter, vehicle-controlled, randomized trial evaluated twice-weekly tacrolimus ointment 0.003% or vehicle in 153 children (2-15 years) with moderate-severe atopic dermatitis (AD). Treatment outcomes, resource use and costs were evaluated. The primary endpoint was the number of major flares (those needing b.i.d. tacrolimus for > 7 days and with an Investigator Global Assessment score of > 1 on day 1 of exacerbation). The tacrolimus group had a decreased number of flares (mean 2.5 vs. 4.5 on vehicle; P < 0.05) and prolonged time to first flare (146 vs. 17 days; P < 0.0001). The mean annual cost was 2002 euros (vehicle) versus 1571 euros on tacrolimus for ...