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Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients
B R Allen1, M Lakhanpaul, A Morris
1Department of Dermatology, University Hospital, Nottingham, UK.
Insights
Topical pimecrolimus cream 1% showed good tolerability and efficacy in children and infants with atopic dermatitis. Minimal systemic exposure was observed, with no expected systemic effects from this three-week treatment.
Area of Science:
- Dermatology
- Pediatrics
- Pharmacology
Background:
- Atopic dermatitis is a common inflammatory skin condition in children.
- Topical treatments are essential for managing atopic dermatitis.
- Pimecrolimus cream is a non-steroidal option for treating atopic dermatitis.
Purpose of the Study:
- To measure pimecrolimus blood concentrations in children and infants.
- To evaluate the tolerability of topical pimecrolimus cream 1%.
- To assess the efficacy of pimecrolimus cream 1% in atopic dermatitis.
Main Methods:
- Three open-label, non-controlled studies were conducted in children and infants.
- Pimecrolimus blood concentrations were measured at various time points.
- Efficacy was assessed using the Eczema Area and Severity Index (EASI).
Main Results:
- Pimecrolimus blood concentrations remained consistently low, with most below 1 ng/ml.
- The cream was well-tolerated, with transient stinging as the most common side effect.
- Significant reductions in EASI scores were observed, indicating rapid and effective treatment.
Conclusions:
- Three-week topical pimecrolimus cream 1% treatment is safe and effective for pediatric atopic dermatitis.
- Minimal systemic absorption suggests a favorable safety profile.
- The treatment demonstrates rapid onset of action and good tolerability in young patients.
Aims:
To measure pimecrolimus blood concentrations and to evaluate tolerability 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, typically (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.
