Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients.
Arch Dis Child
; 88(11): 969-73, 2003 Nov.
Article
in En
| MEDLINE
| ID: mdl-14612358
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tacrolimus
/
Dermatitis, Atopic
/
Dermatologic Agents
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Immunosuppressive Agents
Limits:
Adolescent
/
Child
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Child, preschool
/
Female
/
Humans
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Infant
/
Male
Language:
En
Journal:
Arch Dis Child
Year:
2003
Document type:
Article