Pennsylvania University. US: 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.