Journal Scan / Research · April 19, 2020

No Evidence of Increased Cancer Incidence in Children Using Topical Tacrolimus for Atopic Dermatitis

Journal of the American Academy of Dermatology

TAKE-HOME MESSAGE

• This international, longitudinal, observational cohort study followed nearly 8000 children with atopic dermatitis (AD) using topical calcineurin inhibitors (TCIs) for up to 10 years for the development of incident malignancies. There was no difference between the number of observed and expected malignancies, based on data from national registries matched to age, sex, race, and country of origin (standardized incidence ratio, 1.01). There were 6 incident malignancies, none of which were lymphomas or nonmelanoma skin cancers, and they did not follow any patterns regarding patient age at diagnosis or duration of TCI use.

• The key finding of this study is that the rate of observed incident malignancies among patients using TCIs for AD did not differ from the rate of expected incident malignancies based on national registries. There were no patterns in terms of age or duration of TCI use among the few incident malignancies which did occur.

– Margaret Hammond, MD

Abstract

BACKGROUND

Long-term safety of topical calcineurin inhibitors is not well understood. APPLES™ (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis (AD); NCT00475605) examined incidence of lymphoma and other cancers in a pediatric AD population.

OBJECTIVE

To quantify incident malignancies during 10 years in children with AD who used topical tacrolimus for ≥6 weeks.

METHODS

Standardized Incidence Ratios (SIRs) for cancer events were analysed relative to sex-, age-, and race-matched control data from national cancer registries.

RESULTS

7954 eligible patients enrolled at 314 sites in 9 countries. Over 44629 person-years, six confirmed incident cancers occurred (SIR 1.01 (95% CI 0.37 to 2.20)). No lymphomas occurred.

LIMITATIONS

Observational prospective cohort study.

CONCLUSIONS

Cancer incidence was as expected, given matched background data. This finding provides no support for the hypothesis that topical tacrolimus increases long-term cancer risk in children with AD.

Journal of the American Academy of Dermatology

No Evidence of Increased Cancer Incidence in Children Using Topical Tacrolimus for Atopic Dermatitis

J Am Acad Dermatol 2020 Apr 01;[EPub Ahead of Print], AS Paller, R Fölster-Holst, SC Chen, TL Diepgen, C Elmets, DJ Margolis, BH Pollock