Purpose of the Study.

To examine if pimecrolimus 1% cream in the treatment of atopic dermatitis would have any effect on vaccinations.

Study Population.

A total of 91 children with mild-to-severe atopic dermatitis (AD), aged 3 to 23 months at enrollment.

Methods.

Children were enrolled in a 1-year double-blind study (76 children received pimecrolimus, and 15 children received placebo). All 91 children were enrolled in a 1-year open-label extension study of pimecrolimus 1% cream. Patients were treated with either pimecrolimus 1% cream or placebo for initial symptoms, and more potent topical corticosteroids were used for flares not prevented by pimecrolimus 1% cream. Patients were vaccinated at normal scheduled times (4 doses of tetanus and diphtheria and 1 or 2 doses of measles and rubella). Response was evaluated at months 18 and 24 of the 2-year period.

Results.

The seropositivity rates of 93.6% for tetanus, 88.6% for diphtheria, 88.5% for measles, and 84.4% for rubella were comparable with those reported in the literature. Seropositivity was not significantly affected by the use of pimecrolimus at the time of vaccinations (±28 days). These seropositivity rates were within the ranges of 87% to 100% for tetanus, 83.3% to 99.3 for diphtheria, 60.5% to 97.1% for measles, and 55.6% to 88.1% for rubella, similar to those reported in age-matched pediatric populations.

Conclusion.

Topical pimecrolimus in the treatment of atopic dermatitis had no effect on the response to routine childhood vaccination.

Reviewer Comments.

Topical pimecrolimus, similar to topical tacrolimus (J Am Acad Dermatol. 2005;53[2 suppl 2]:S206–S213), had no effect on routine childhood vaccination. These topical calcineurin inhibitors did not affect basic B-cell function as measured by postvaccination titers.

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