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Long-term intermittent maintenance use of topical tacrolimus in pediatric patients with atopic dermatitis

Two studies, one US and one European (EU), evaluated the safety and efficacy of long-term intermittent maintenance treatment with tacrolimus 0.03% ointment versus standard treatment (vehicle plus tacrolimus rescue treatment) in preventing atopic dermatitis (AD) flares in children aged 2-15 years. The US study randomized patients with moderate-severe AD to 4 days of b.i.d. double-blind therapy with either alclometasone 0.05% or tacrolimus 0.03% ointment followed by a stabilization phase of up to 16 weeks with open label tacrolimus b.i.d. Patients who stabilized (clear or almost clear assessments) were randomized to tacrolimus or vehicle once a day 3 times a week for up to 40 weeks (the maintenance phase). The primary endpoint was ...