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

Amy S. Paller*, Regina Fölster-Holst, Suephy C. Chen, Thomas L. Diepgen, Craig Elmets, David J. Margolis, Brad H. Pollock

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

51 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)375-381
Number of pages7
JournalJournal of the American Academy of Dermatology
Issue number2
StatePublished - Aug 2020


  • atopic dermatitis
  • cancer risk
  • lymphoma
  • skin cancer
  • tacrolimus
  • topical calcineurin inhibitors

ASJC Scopus subject areas

  • Dermatology


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