Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients

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Abstract

Alms: To measure pimecrolimus blood concentrations and to evaluate tolerabllity and efficacy in children and infants treated topically for atopic dermatitis with pimecrolimus cream 1% for three weeks. Methods: Three open label, non-controlled, multiple topical dose studies were conducted in children aged 8-14 years (study A, ten patients), and in infants aged 8-30 months (study B, eight patients) and 4-11 months (study C, eight patients). Pimecrolimus blood concentrations were determined on days 4 and 22 of treatment, and at end of study. Efficacy was assessed using the Eczema Area and Severity Index (EASI). Results: Pimecrolimus blood concentrations were consistently low, typicolly (81%) below 1 ng/ml, with more than half of the measurements below the assay limit of quantitation (0.5 ng/ml) in studies A and B. The highest blood concentration measured throughout the three studies was 2.6 ng/ml. The cream was well tolerated, locally and systemically. The most common adverse event suspected to be related to study medication was a transient mild to moderate stinging sensation at the application site in 5/26 patients. There was no indication of any systemic adverse effect. The patients responded well to therapy with a rapid onset of action, usually within four days. Median reductions of EASI from baseline at day 22 were 55% (study A), 63% (study B), and 83% (study C). Conclusion: Three weeks treatment of children and infants with extensive atopic dermatitis, using pimecrolimus cream 1% twice daily, is well tolerated and results in minimal systemic exposure, at which no systemic effect is expected.

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Allen, B. R., Lakhanpaul, M., Morris, A., Lateo, S., Davies, T., Scott, G., … Stephenson, T. J. (2003). Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Archives of Disease in Childhood, 88(11), 969–973. https://doi.org/10.1136/adc.88.11.969

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