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Abstract
Pimecrolimus (SDZ ASM 981, Elidel®) is an ascomycin macrolactam derivative and a cell-selective inhibitor of inflammatory cytokines specifically developed to treat inflammatory skin diseases. Pimecrolimus combines high anti-inflammatory activity in the skin with a low potential to impair systemic immune reactions. Multi-centre studies have proved the efficacy and safety of pimecrolimus cream in patients with atopic dermatitis (AD) and confirmed that it is suitable for short-term treatment and long-term management of AD in adults, children and infants as young as 3 months. Topical application in humans is not associated with the atrophogenic side effects observed with corticosteroids. Pimecrolimus blood levels remained consistently low after repeated topical application and no clinically relevant drug-related systemic adverse events have been reported among the 8000 patients treated in clinical trials so far. Short-term, Phase I/II and Phase II trials of pimecrolimus administered orally in psoriasis and AD have shown that this drug is highly effective in a dose-dependent manner in patients with these diseases and has high safety profile. This finding is confirmed by pharmacogenomic blood analysis. Available data thus indicates that pimecrolimus, in both the cream and oral formulations, may represent a new option for the treatment of inflammatory skin diseases.