Low systemic exposure in infants with atopic dermatitis in a 1-year pharmacokinetic study with pimecrolimus cream 1%*

Area of Science:

• Dermatology
• Pharmacology
• Pediatrics

Background:

• Infants have a higher surface area to body mass ratio, increasing systemic drug absorption risk from topical agents.
• Atopic dermatitis (AD) management in infants requires careful safety considerations regarding topical treatments.
• Systemic drug exposure is a critical safety concern for infants using topical medications.

Purpose of the Study:

• To evaluate systemic drug exposure in infants with moderate-to-severe atopic dermatitis treated with pimecrolimus cream 1%.
• To assess the safety and tolerability of long-term pimecrolimus cream 1% application in infants.

Main Methods:

• An open-label, non-controlled study involving five infants (5.7-11.9 months) with extensive AD.
• Patients received pimecrolimus cream 1% twice daily for one year, as needed.
• Pimecrolimus blood concentrations were monitored throughout the study period.

Main Results:

• Pimecrolimus blood concentrations remained consistently low, below 1.94 ng/ml.
• No evidence of drug accumulation was observed during the 1-year treatment period.
• Treatment was well tolerated with no reported treatment-related adverse events.

Conclusions:

• Long-term management of atopic dermatitis in infants with pimecrolimus cream 1% demonstrates very low systemic absorption.
• Pimecrolimus cream 1% is safe and well-tolerated for extended use in infants, even those with extensive disease.
• The study supports the use of pimecrolimus cream 1% for managing infant atopic dermatitis with minimal systemic risk.