Topical tacrolimus does not increases long-term cancer risk in children with atopic dermatitis (AD), according to study findings published in the Journal of the American Academy of Dermatology.

The APPLES™ (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis (AD); NCT00475605) study evaluated whether topical treatment with tacrolimus 0.03% or 0.1% ointment increased incidence of lymphoma and other cancers in a pediatric AD population. Children with AD were included if their first exposure to tacrolimus occurred before the age of 16 and if they used topical tacrolimus for ≥6 weeks. In total, 7954 eligible patients (mean age, 7.1; first dose of topical tacrolimus at 5.4±4.2 years) were enrolled at 314 sites in 9 countries across North America and Western Europe from May 2005 to August 2012. The primary endpoint was the standardized incidence ratio (SIRs) for cancer events which were evaluated relative to age, sex, and race-matched control data from national cancer registries.

The observed rate of all incident cancers, 6 confirmed events per 44,629 person-years, was consistent with expectations for an age-, sex, race-, and country-of-origin-matched population. There was no significant divergence between the number of observed and expected incident ratios, with the overall SIR at 1.01 (95% CI, 0.37-2.20). The calculated incidence of malignancies in APPLES excludes the hypothesized tripling of cancer risk that the study was statistically powered to detect. Furthermore, there was a complete absence of incident lymphomas during the APPLES study.

Limitations of the study include the risk for biased enrollment and or/biased drop-out, recall bias, and being underpowered to detect certain cancer types.


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The investigators concluded that the APPLES study provides no evidence for the hypothesis that topical tacrolimus increases long-term cancer risk in children with AD.

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Disclosures: Some of the authors declared affiliations with pharmaceutical and/or medical companies. For a full list of disclosures, please refer to the study abstract.

Please see the original reference for a full list of authors’ disclosures.

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Reference

Paller AS, Folster-Holst R, Chen SC, et al. No evidence of increased cancer incidence in children using topical tacrolimus for Atopic dermatitis (published online April 1, 2020). J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.03.075