No evidence of increased cancer incidence in children using topical tacrolimus for atopic dermatitis.

Journal Article (Journal Article;Multicenter Study)

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; NCT00475605) examined incidence of lymphoma and other cancers in a pediatric population with atopic dermatitis. OBJECTIVE: To quantify incident malignancies during 10 years in children with atopic dermatitis who used topical tacrolimus for ≥6 weeks. METHODS: Standardized incidence ratios for cancer events were analyzed relative to sex-, age-, and race-matched control data from national cancer registries. RESULTS: There were 7954 eligible patients enrolled at 314 sites in 9 countries. During 44,629 person-years, 6 confirmed incident cancers occurred (standardized incidence ratio, 1.01; 95% confidence interval, 0.37-2.20). No lymphomas occurred. LIMITATIONS: Observational prospective cohort study. CONCLUSION: The 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 atopic dermatitis.

Full Text

Duke Authors

Cited Authors

  • Paller, AS; Fölster-Holst, R; Chen, SC; Diepgen, TL; Elmets, C; Margolis, DJ; Pollock, BH

Published Date

  • August 2020

Published In

Volume / Issue

  • 83 / 2

Start / End Page

  • 375 - 381

PubMed ID

  • 32246968

Electronic International Standard Serial Number (EISSN)

  • 1097-6787

Digital Object Identifier (DOI)

  • 10.1016/j.jaad.2020.03.075


  • eng

Conference Location

  • United States