WAILEA, HAWAII (FRONTLINE MEDICAL NEWS) – With the recent approval of crisaborole ointment 2% for the treatment of atopic dermatitis, the question of how to best utilize this novel drug in daily clinical practice was put to two atopic dermatitis experts at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Research Foundation.

Two of these experts, Lawrence F. Eichenfield, MD, and Wynnis L. Tom, MD, have garnered extensive clinical trials experience with crisaborole ( Eucrisa ), which, in December 2016, became the first prescription drug approved by the Food and Drug Administration for atopic dermatitis (AD) in more than 10 years. The topical phosphodiesterase-4 inhibitor is indicated for twice-daily treatment of patients aged 2 years and older with mild to moderate AD.

Dr. Eichenfield , who presented up to 52 weeks of long-term safety data on crisaborole at the 2016 annual meeting of the European Academy of Dermatology and Venereology in Vienna, said that he won’t change his standard first-line approach in response to the drug’s availability on pharmacy shelves.

“Topical steroids are the most cost-effective medicine for the management of acute flares of atopic dermatitis. And if I can then take patients down to only intermittent use of topical corticosteroids of mid-strength or lower, depending on patient age, I’ll probably hang in and do just that,” said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital-San Diego.

“But, when I have patients with more persistent disease, frequent flaring where I can’t get by with just twice-a-week topical steroids, or … sensitive areas where I need to avoid steroid atrophy, that’s when I’m likely to incorporate a nonsteroidal agent into regimens of care. Traditionally, over the past 15-18 years, that’s been either with topical tacrolimus [ Protopic ] or pimecrolimus [ Elidel ]. And now crisaborole will fit right in there,” he continued.

As for how long to keep patients on crisaborole, Dr. Eichenfield noted that the package labeling “is pretty open.” It doesn’t address the question of treatment duration, and the patient handout that accompanies the tube of ointment simply states, “Use [crisaborole] Eucrisa exactly as your health care provider tells you to use it.”

“In a no-data situation such as this, I’ll probably try to see if use a few times a week or in a mix/match between corticosteroids, a topical calcineurin inhibitor, and crisaborole will provide decent long-term disease control,” Dr. Eichenfield said.

The important, remaining questions regarding crisaborole include, Is it comparatively efficient? – a question that will require head-to-head clinical trials. Is it cost effective? Will it be effective and safe in children younger than 2 years of age? Is it safe beyond 1 year of use? – a particularly important question, given that the phase III clinical trials were only a month long, the dermatologist added.

Dr. Eichenfield emphasized that he was offering only his personal opinion on the use of crisaborole in response to audience questions. Eventually, guidelines committees will formally address how to incorporate the new drug into a sound treatment strategy.

Dr. Tom , like Dr. Eichenfield, was a coauthor of the two pivotal phase III randomized trials of crisaborole, which found infrequent and minimal side effects along with significant improvement of formal quality of life measures ( J Am Acad Dermatol. 2016 Sep;75[3]:494-503.e4 ).

She said that one way she’ll immediately put the new topical agent to work is in treating disease on the face and other sensitive skin areas. The drug’s steroid-sparing ability is also a major asset, given how many parents of children with AD are steroid phobic.

“I’m certainly not going to give up on topical steroids, but anything that enables me to lessen their use is a comfort for parents. That’s really important,” observed Dr. Tom of the University of California, San Diego, and Rady Children’s Hospital.

Both pediatric dermatologists reported having received research grants from or serving as consultants to roughly half-a-dozen pharmaceutical companies, including Anacor/Pfizer, which markets crisaborole.

SDEF and this news organization are owned by the same parent company.


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