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No evidence of increased cancer incidence in children using topical tacrolimus for atopic dermatitis - 23/07/20

Doi : 10.1016/j.jaad.2020.03.075 
Amy S. Paller, MD a, , Regina Fölster-Holst, MD b, Suephy C. Chen, MD, MS c, Thomas L. Diepgen, MD, PhD d, Craig Elmets, MD e, David J. Margolis, MD, PhD f, Brad H. Pollock, MPH, PhD g
a Departments of Dermatology and Pediatrics, Northwestern University School of Medicine, Chicago, Illinois 
b The Department of Dermatology, University Clinics, Schleswig-Holstein Campus, Kiel, Germany 
c The Department of Dermatology, Emory University School of Medicine and Regional TeleHealth Service VISN7, Atlanta, Georgia 
d The Department of Clinical Social Medicine, Occupational & Environmental Dermatology, University Hospital Heidelberg at Ruprecht-Karls University Heidelberg, Heidelberg, Germany 
e The Department of Dermatology and the O'Neal Comprehensive Cancer Center, University of Alabama School of Medicine, Birmingham, Alabama 
f The Departments of Dermatology and Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 
g The Department of Public Health Sciences, School of Medicine, University of California, Davis, California 

Correspondence and reprint requests to: Amy S. Paller, MD, Department of Dermatology, Northwestern University Feinberg School of Medicine, 676 N St Clair, Ste 1600, Chicago IL 60611.Department of DermatologyNorthwestern University Feinberg School of Medicine676 N St ClairSte 1600ChicagoIL60611

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; 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.

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Key words : atopic dermatitis, cancer risk, lymphoma, skin cancer, tacrolimus, topical calcineurin inhibitors

Abbreviations used : AD, APPLES, CI, JOELLE, SIR, TCI, TCS, US


Plan


 Funding sources: The APPLES study (A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis) was initiated by Fujisawa and later sponsored by Astellas Pharma and LEO Pharma. LEO Pharma Inc, provided medical writing assistance for this publication.
 Conflicts of interest: Dr Paller is an investigator for AbbVie, Anaptysbio, Celgene, Eli Lilly, Galderma, Incyte, LEO Pharma Inc, Janssen, Novartis, and Sanofi-Regeneron, and is a consultant with honorarium for AbbVie, Amgen, Asana, Celgene, Dermavant, Dermira, Galderma, Eli Lilly, Forte, LEO Pharma Inc, Menlo, Novartis, Pfizer, Regeneron, and Sanofi-Genzyme. Dr Fölster-Holst is a consultant, speaker, and clinical researcher for Almirall Hermal, Beiersdorf AG, Johnson & Johnson, LEO Pharma Inc, Neubourg GmbH, Novartis, Pierre Fabre, Pfizer, Procter & Gamble, Regeneron Pharmaceuticals, and Sanofi-Aventis. Dr Margolis is a consultant on atopic dermatitis for Pfizer, LEO Pharma Inc, and Sunovion, an advisor for the National Eczema Association, and receives research support from Valeant. Drs Chen, Diepgen, Elmets, and Pollock have no conflicts of interest to declare.
 Parts of this study were presented as an abstract at the 28th European Academy of Dermatology and Venereology (EADV) Congress, Madrid Spain, October 9-13, 2019.
 IRB approval status: An Institutional Review Board or Independent Ethics Committee for each participating site approved the study protocol.
 This work is dedicated to the memory of Thomas L. Diepgen.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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P. 375-381 - août 2020 Retour au numéro
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