LOS ANGELES — Crisaborole, a topical phosphodiesterase 4 inhibitor, improved the symptoms of mild to moderate eczema in two phase 3 safety and efficacy trials.
This new drug, if approved, could be used as an alternative to steroids and calcineurin inhibitors. Both of these agents can be helpful for the condition but can make parents nervous, said Mark Boguniewicz, MD, from the University of Colorado School of Medicine in Aurora.
The quantity and locations in which steroids can be used are limited because of the potential for thinning in the face, underarms, and groin. They are also somewhat stigmatized. "No matter how much we educate some families, there's a huge steroid phobia in the community, sometimes bordering on the irrational," he told Medscape Medical News.
"Some families hate to use topical steroids, not only in children, but also in adults," he added.
In fact, "if you tell them a prescription is for a topical steroid, they back away," James Fox, MD, from Fox Skin and Allergy Associates in Branchburg, New Jersey, told Medscape Medical News.
In addition, the black-box warning for cancer risk can be a deterrent to the use of topical calcineurin inhibitors.
Dr Boguniewicz presented the research during a poster session here at the American Academy of Allergy, Asthma and Immunology 2016 Annual Meeting.
Study Results
The two studies involved patients 2 years and older with mild to moderate eczema. They were randomly assigned to apply crisaborole ointment or a control vehicle twice daily, and were evaluated on days 8, 15, 22, and 29.
In study 1 (NCT02118766), there were 503 patients in the crisaborole group and 256 in the control group; in study 2 (NCT02118792), there were 531 and 250 patients, respectively. The design of the two studies was identical.
Researchers assessed disease severity using the 6-point Investigator's Static Global Assessment (clear, almost clear, mild, moderate, severe, very severe). More patients in the crisaborole group than in the control group achieved the primary end point of success on day 29, defined as a score indicating that the disease was clear or almost clear and an improvement of at least 2 points from baseline.
And more patients in the crisaborole group achieved a score indicating they were clear or almost clear of eczema — a secondary end point.
Table. Day 29 Outcomes on Investigator's Static Global Assessment
| Outcome | Crisaborole Group, % | Control Group, % | P Value |
| Study 1 | |||
| Success | 32.8 | 25.4 | .038 |
| Clear or almost clear | 51.7 | 40.6 | .005 |
| Study 2 | |||
| Success | 31.4 | 18.0 | <.001 |
| Clear or almost clear | 48.5 | 29.7 | <.001 |
None of the patients experienced any serious adverse events, but there was more application-site pain in the crisaborole group than in the control group (4.4% vs 1.2%).
"We're always looking for novel, nonsteroidal, safe, and effective treatments. A number of tested products have so far fallen short. It's been a while since we've had anything to get excited about," Dr Boguniewicz said.
Dr Fox said he is also enthusiastic. "This is a nice alternative for young children with eczema." He said he would likely prescribe crisaborole if it became available. "It depends on the cost, insurance coverage, and all the other usual things, but it looks very promising."
Parents have to understand that eczema is a recurrent disease that requires continued management.
"In a busy clinic, parents don't get educated that this is a relapsing condition," Dr Boguniewicz explained. "Many families think they can get a medication as they would for an ear infection or strep throat, and in 10 days it's going to be the end of the problem. When the condition comes back, it gets frustrating."
In fact, these two studies showed that many cases of childhood eczema persist into adulthood.
The "data show that even if the condition is mild to moderate, about 50% of patients continue to have eczema into their 20s. So all of these people who have been told, 'your child is going to outgrow it,' are quite frustrated," Dr Boguniewicz reported.
These studies were funded by Anacor Pharmaceuticals. Dr Boguniewicz received support from Anacor Pharmaceuticals. Dr Fox has disclosed no relevant financial relationships.
American Academy of Allergy, Asthma and Immunology (AAAAI) 2016 Annual Meeting: Abstract L25. Presented March 6, 2016.
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Cite this: Investigational Ointment Improves Eczema - Medscape - Mar 16, 2016.
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