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Topical pimecrolimus use in pediatric AD not associated with increased malignancy risk

Topical pimecolimus treatment in children with atopic dermatitis appeared to have no association with increased risk of malignancy when compared with other data, according to recently published study results.

Researchers conducted a longitudinal study of 7,457 children with a history of atopic dermatitis (AD) and pimecrolimus use enrolled in the ongoing Pediatric Eczema Elective Registry (PEER). Data were available through May 2014 for a total of 26,792 person-years. Mean age of AD onset was 2.3 years.

The study’s primary outcome was reported malignancy among children in the PEER compared with expected rates from the Surveillance, Epidemiology, and End Results (SEER) program.

The children were treated with a mean of 793 g of pimecrolimus during study enrollment. There were five malignancies, including two leukemias, one osteosarcoma and two lymphomas, reported during that time. No skin cancers were reported. The PEER population had an overall rate of observed malignancies of 18.7 (95% CI, 6.1-43.6) per 100,000 person-years, according to the researchers.

Based on the age-standardized SEER population, the standardized incidence ratio (SIR) for all malignancies was 1.2 (95% CI, 0.5-2.8), less than the prespecified ratio of 2.8. The two leukemia cases had an SIR of 2.9 (95% CI, 0.7-11.7), whereas the leukemia cases had an SIR of 2.0 (95% CI, 0.5-8.2). – by Bruce Thiel

Disclosures: Margolis reported serving on a data safety monitoring board for the Astellas Pharma APPLES study (A Pediatric Longitudinal Evaluation to Assess the Long-term Safety of Protopic for the Treatment of Atopic Dermatitis). The other researchers reported no relevant financial disclosures.