Amy S Paller1, Regina Fölster-Holst2, Suephy C Chen3, Thomas L Diepgen4, Craig Elmets5, David J Margolis6, Brad H Pollock7. 1. Departments of Dermatology and Pediatrics, Northwestern University School of Medicine, Chicago, Illinois. Electronic address: apaller@northwestern.edu. 2. The Department of Dermatology, University Clinics, Schleswig-Holstein Campus, Kiel, Germany. 3. The Department of Dermatology, Emory University School of Medicine and Regional TeleHealth Service VISN7, Atlanta, Georgia. 4. The Department of Clinical Social Medicine, Occupational & Environmental Dermatology, University Hospital Heidelberg at Ruprecht-Karls University Heidelberg, Heidelberg, Germany. 5. The Department of Dermatology and the O'Neal Comprehensive Cancer Center, University of Alabama School of Medicine, Birmingham, Alabama. 6. The Departments of Dermatology and Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. 7. The Department of Public Health Sciences, School of Medicine, University of California, Davis, California.
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.
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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