Pimecrolimus, a topical cream used to treat eczema in children, does not appear to confer an increased risk of hematologic and other cancers, according to researchers.
In 2001 and 2002, respectively, the US Food and Drug Administration and the European Medicines Agency approved pimecrolimus to treat eczema in children 2 years of age and older.
The product was approved with a black box warning describing a potential risk of malignancy.
To investigate this risk, and as part of the post-marketing commitments for the approval of pimecrolimus, researchers initiated the Pediatric Eczema Elective Registry (PEER) study in 2004.
David J. Margolis, MD, PhD, of the University of Pennsylvania in Philadelphia, and his colleagues analyzed data from this study, comparing the incidence of malignancy among PEER subjects to expected cancer rates from the Surveillance, Epidemiology and End Results program.
The team reported their findings in JAMA Dermatology.
The PEER study enrolled 7457 children (26,792 person-years) who used an average of 793 g of pimecrolimus while on study.
As of May 2014, 5 malignancies were reported in these children: 2 leukemias, 2 lymphomas, and 1 osteosarcoma.
No skin cancers were reported, and none of the findings regarding cancer incidence were statistically significant.
The researchers therefore said it’s unlikely that topical pimecrolimus, as it was used in the PEER study, is associated with an increased risk of malignancy.
This research and the PEER study were both funded by Valeant Pharmaceuticals International, makers of pimecrolimus.
In a related editorial in JAMA Dermatology, Jon M. Hanifin, MD, of Oregon Health and Science University in Portland, said he hopes this research will improve the management of eczema by countering any concerns about pimecrolimus use that were raised by the treatment’s black box warning.
“The positive and optimistic report of pimecrolimus post-marketing surveillance by Margolis et al should help reduce the physician and pharmacist concerns that have restricted the use of these effective topical alternatives to corticosteroids,” Dr Hanifin wrote. “The interim results should help bring relief to a larger segment of the many young individuals with [eczema].”
