Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants.

Author(s): Kaufmann R, Folster-Holst R, Hoger P, Thaci D, Loffler H, Staab D, Brautigam M, CASM981CDE04-Study Group

Affiliation(s): Department of Dermatology and Venereology, Johann Wolfgang Goethe-Universitat, Hautklinik, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. kaufmann@em.uni-frankfurt.de

Publication date & source: 2004-11, J Allergy Clin Immunol., 114(5):1183-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Data on the efficacy of pimecrolimus cream 1% within the first days of treatment are scarce, as in previous studies, the first postbaseline assessment was performed only after 1 week. OBJECTIVE: We sought to investigate the onset of action of pimecrolimus cream 1% in infants with mild to very severe atopic eczema. METHODS: We used pimecrolimus cream 1% (n = 129) or vehicle cream (n = 66) administered in a double-blind manner for 4 weeks and then open-label pimecrolimus cream 1% for 12 weeks, with a 4-week follow-up period. RESULTS: Pimecrolimus cream 1% reduced the mean Eczema Area and Severity Index at 4 weeks by 71.5% compared with an increase of 19.4% with vehicle ( P < .001). The reduction in the Eczema Area and Severity Index with pimecrolimus cream 1% was significant at day 4 (38.5% vs 17.6% increase with vehicle). Significant improvements in caregivers' assessments of pruritus and sleep loss were observed with pimecrolimus cream 1% by day 2 ( P < .03) and day 3 ( P = .002), respectively, compared with vehicle. Responses to pimecrolimus cream 1% were sustained during the open-label phase, and pimecrolimus cream 1% was well tolerated. Symptoms of atopic eczema returned gradually after discontinuation. CONCLUSION: Pimecrolimus cream 1% was well tolerated and effective in patients with mild to very severe atopic eczema, with rapid onset of action and no disease rebound after discontinuation.