New hope for eczema
Approved treatment is the first new prescription for chronic, inflammatory atopic dermatitis in kids in more than a decade.
The US Food and Drug Administration (FDA) has announced its approval of a new, corticoid-sparing ointment to treat mild to moderate atopic dermatitis in pediatric patients aged 2 years and older.
Crisaborole (Eucrisa; Anacor Pharmaceuticals; Palo Alto, California) is a phosphodiesterase 4 (PDE-4) inhibitor that is applied topically twice daily. Its precise mechanism of action in atopic dermatitis, however, isn’t known, according to the FDA.
The FDA’s approval is based on 2 placebo-controlled trials studying 1522 patients, aged from 2 years to 79 years, with mild to moderate atopic dermatitis. Overall, those in the active group had a greater response with clear or almost clear skin after 28 days of treatment with Eucrisa.
Hypersensitivity reactions are among the most serious adverse reactions. The FDA cautions that Eucrisa should not be used in patients who have had a hypersensitivity reaction to crisaborole. Pain, burning, or stinging are common at the site of application.
“We welcome this corticosteroid-sparing topical option,” says Elaine C. Siegfried, MD, professor of pediatrics and dermatology at Saint Louis University School of Medicine, SSM Health Cardinal Glennon Children's Hospital, Saint Louis, Missouri. “The other 2 alternatives (pimecrolimus cream and tacrolimus ointment) carry black box warnings and labelled limitation on duration of use. Although most pediatric dermatologists prescribe these medications in infants and children without long-term safety concerns, prescribing Eucrisa is not hampered by this medicolegal burden. However, cost and access could be a limitation.”
Adam Friedman, MD, associate professor of dermatology and director of translational research in dermatology at the George Washington School of Medicine and Health Sciences, Washington, DC, says that this most recent approval represents the exciting first of hopefully many new approved therapies for an exceedingly common disease state, which until recently was largely ignored.
“I envision crisaborole being used in a similar manner to calcineurin inhibitors, both as proactive treatment for affected delicate areas like the eyelids, face, body folds, groin, or mild disease elsewhere. But, more importantly, [I envision it] as preventative maintenance therapy for disease areas that recur frequently after topical steroid use has been discontinued (though without the baggage of a black box warning and possible substance P-induced burning at the onset of use),” he says.
Friedman, who recently presented on the topic of eczema at the 2017 Orlando Dermatology Aesthetic and Clinical Conference in January in Miami, Florida, says this approval, however, should not overshadow the basic and requisite elements for properly managing atopic dermatitis, often a chronic, inflammatory condition. These basics are: clear patient education on a broad range of topics, including realistic expectations; proper soap, moisturizer, and treatment use; and myths about treatment safety, in order to gain the patient's confidence, which, in turn, increases the likelihood of regimen compliance, he says.