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

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...

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Main Authors: Paller, Amy S. (Author) , Fölster-Holst, Regina (Author) , Chen, Suephy C. (Author) , Diepgen, Thomas L. (Author) , Elmets, Craig (Author) , Margolis, David J. (Author) , Pollock, Brad H. (Author)
Format: Article (Journal)
Language:English
Published: 1 April 2020
In: Journal of the American Academy of Dermatology
Year: 2020, Volume: 83, Issue: 2, Pages: 375-381
ISSN:1097-6787
DOI:10.1016/j.jaad.2020.03.075
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.jaad.2020.03.075
Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S0190962220304989
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Author Notes:Amy S. Paller, MD, Regina Fölster-Holst, MD, Suephy C. Chen, MD, MS, Thomas L. Diepgen, MD, PhD, Craig Elmets, MD, David J. Margolis, MD, PhD, and Brad H. Pollock, MPH, PhD
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Summary: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.
Item Description:Gesehen am 30.10.2020
Physical Description:Online Resource
ISSN:1097-6787
DOI:10.1016/j.jaad.2020.03.075

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