Paller AS, Eichenfield LF, Kirsner RS, et al. Pediatrics. 2008;122(6). Available at: www.pediatrics.org/cgi/content/full/122/6/e1210
PURPOSE OF THE STUDY. To evaluate the safety and efficacy of intermittent topical tacrolimus as maintenance therapy in patients with moderate-to-severe atopic dermatitis.
STUDY POPULATION. Subjects 2 to 15 years of age with moderate-to-severe atopic dermatitis.
METHODS. Subjects underwent stabilization with either 0.05% aclometasone ointment or 0.03% tacrolimus in a double-blind fashion for 4 days, followed by twice-daily, open-label, 0.03% tacrolimus treatment for all subjects. Subjects who became “clear” or “almost clear” entered phase II (maintenance phase) and underwent double-blind, random assignment to either 0.03% tacrolimus or vehicle applied once daily, 3 times per week, for up to 40 weeks. Emollients were permitted, but corticosteroid use was prohibited; open-label tacrolimus use was permitted to treat relapses.
RESULTS. A total of 206 patients were randomly assigned, and 50 subjects completed the study. There were no significant differences between groups at baseline. Aclometasone-treated patients showed more improvement in the acute phase than did tacrolimus-treated patients, and there were no differences in application-site adverse events between groups. During maintenance, tacrolimus-treated patients had a significantly greater number of disease-free treatment days, compared with vehicle-treated patients (mean: 174 vs 107 days; P = .0008), and a longer time to first relapse (median: 116 vs 31 days; P < .04).
CONCLUSIONS. Long-term intermittent application of 0.03% tacrolimus to clinically normal-appearing but previously affected skin was significantly more effective than vehicle at maintaining disease stabilization in patients with moderate-to-severe atopic dermatitis. The safety profile of intermittently applied tacrolimus was similar to that of vehicle.
REVIEWERS COMMENTS. Atopic dermatitis is a chronic relapsing disease. Prevention of relapse is aimed at skin hydration and avoidance of triggers. Adverse effects of topical steroids limit their long-term use and, although there are concerns that calcineurin inhibitors may carry an increased risk of malignancy, long-term data on the safety of topical calcineurin inhibitors contradict this notion. This study shows promise that intermittent application of 0.03% tacrolimus offers a novel, steroid-sparing approach to maintaining stabilization of atopic dermatitis that seems both safe and efficacious.
- Copyright © 2009 by the American Academy of Pediatrics