Atopic dermatitis (AD) is characterized by disease-free periods interrupted by exacerbations (C. A. Akdis, 2006). Maintenance therapy with tacrolimus ointment may prevent disease recurrence.
Pediatric and adult patients with clear or almost clear disease after <=16 weeks of treatment with tacrolimus ointment were randomized to receive either vehicle or tacrolimus ointment (pediatric = 0.03%; adult = 0.1%) in the maintenance phase of this study. The safety and efficacy of tacrolimus therapy for recurrence prevention were evaluated (D. Breneman, 2008).
A total of 197 of 288 patients with clear or almost clear disease were eligible and entered the maintenance phase of this study. Patients treated with tacrolimus ointment had more flare-free treatment days than those treated with vehicle (M = 177.4 vs. 134.1; p = .003), a longer time to first relapse (median = 169 vs. 43; p = .037), fewer relapse days (45.5 vs. 64.5; p = .027) and fewer relapses per patient (p = .027). The severity of relapses was similar for both groups (p = .140) as was the incidence of cutaneous adverse events (tacrolimus ointment = 8.0%; vehicle = 8.5%). The most common adverse events were application-site burning and pruritus (D. Breneman, 2008).
Long-term treatment with tacrolimus ointment in patients with clear or almost clear AD results in significantly more disease-free days and safely and effectively reduces the risk for disease relapse.
When used as directed, treatment with tacrolimus ointment is a safe and effective method to control disease in patients with stabilized AD.