Study Following Large Cohort of Children for Ten Years Part of Post-Marketing Requirement
PHILADELPHIA — The topical eczema medicine pimecrolimus appears unlikely to be associated with an increased risk of cancer in children, based on a group of children who were followed for 10 years, according to study published online this week in JAMA Dermatology.
The Pediatric Eczema Elective Registry (PEER) study has enrolled 7,457 children (26,792 person-years) since 2004. The children used an average of 793 grams of pimecrolimus when enrolled in the study. As of May 2014, five malignancies were reported: two leukemias, one osteosarcoma and two lymphomas. No skin cancers were reported, and these findings on incidence (a measure of risk) of cancer overall were not statistically significant, according to first author David J. Margolis, MD, PhD, a professor of Dermatology at the Perelman School of Medicine at the University of Pennsylvania, and coauthors.
“Based on more than 25,000 person-years of follow-up, it seems unlikely that topical pimecrolimus as it was generally used in the PEER cohort to treat eczema is associated with an increased risk of malignancy,” the authors conclude.
The U.S. Food and Drug Administration (FDA) and the European Union Medicines Agency have approved few topical agents to treat eczema in children, but in 2001 the FDA and the European Medicines Agency in 2002 approved pimecrolimus to treat eczema in children at least 2 years old. A “black box warning” describes the potential risk of malignancy associated with the topical use of pimecrolimus, a topical calcineurin inhibitor. Oral calcineurin inhibitors were originally approved as immunosuppressive treatments for patients after solid organ transplant to prevent rejection although these treatments are associated with an increased risk of cancer, especially skin cancer and lymphoma.
The PEER study was started in 2004 as part of the post-marketing commitments for the approval of pimecrolimus as an eczema medication for children. Eczema is a common and chronic inflammatory skin condition that most frequently occurs in the first decade of life.
Editor’s Note: This study and the PEER study were funded by Valeant Pharmaceuticals International through a grant to the Trustees of the University of Pennsylvania.
For more information, please see the JAMA release.