Pimecrolimus cream safe for infants with eczema

NEW YORK (Reuters Health) - While pimecrolimus cream can be very effective for treating atopic dermatitis (often called eczema), there has been concern about infections because it is an immune suppressing drug -- but that seems to be unfounded.

A review of clinical trials that tested pimecrolimus cream in infants with atopic dermatitis indicates that it is not associated with a higher rate of infections, other adverse events or generalized immune suppression, investigators report in the medical journal Pediatrics.

Pimecrolimus (marketed as Elidel, by Novartis) is a topical agent that blocks the release of inflammatory factors from immune cells that cause atopic dermatitis. It is applied twice daily to all affected areas of skin until clearance is complete, then resumed when the condition recurs.

Dr. Carle Paul, with Novartis Pharm AG in Basel, Switzerland, and colleagues reviewed four studies and six clinical trials that involved over 1100 patients. All of the subjects were between 3 and 23 months old.

The results indicate that when kids were treated with the 1-percent pimecrolimus cream, levels of the drug in the bloodstream "remain low during treatment for up to 1 year."

Reactions at the site of application, including burning and redness, occurred in less than 1 percent of the treated infants and tended to decrease with longer duration of treatment, the investigators report.

They also found that the rate of non-skin infections, skin infections (bacterial fungal, parasitic, and viral), and serious skin infections were similar between groups treated with the active cream or a "placebo" cream.

Moreover, pimecrolimus did not interfere with the children's response to routine vaccinations.

Based on these findings, Paul's team writes, "Pimecrolimus cream may represent an alternative to topical corticosteroids for young pediatric patients."

SOURCE: Pediatrics, January 2006.