Atopic dermatitis has a tremendous affect on quality of life, so it’s nice to have more options to treat patients in a different way, noted Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego.
Atopic dermatitis has a tremendous affect on quality of life, so it’s nice to have more options to treat patients in a different way, noted Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and vice-chair and professor of dermatology and pediatrics at UC San Diego School of Medicine, in an interview ahead of this year’s American Academy of Dermatology Virtual Meeting Experience (AAD VMX). He is first author of the poster, “Efficacy and Safety of Ruxolitinib Cream Among Adolescents With Atopic Dermatitis: Pooled Results From Two Phase 3 Studies,” which will be presented at AAD VMX.
Can you preview for us your poster being presented at AAD VMX?
We're in this sort of revolutionary time period with both new topical and systemic medicines that are coming, which is especially good given that we're really appreciating now the impact of atopic dermatitis on individuals. Not just the rashes and the symptoms, with itch being a predominant one, but also the secondary effects, with sleep disturbance, the really tremendous quality-of-life impact, family impact, psychological effects, etc. It's nice that we're starting to get an expanded set of options to take care of our patients in a different way and drive different kinds of outcomes.
Topical ruxolitinib has been developed as a cream, as a topical selector, which can inhibit JAK1 and JAK2, 2 of the receptors associated with what's called the JAK-STAT pathway. There are 2 very large phase 3 trials that studied ruxolitinib cream in adolescents and adults. They included patients 12 and older and are showing anti-inflammatory effect and efficacy, along with antipruritic effect. And these were vehicle-control studies, so they were comparing ruxolitinib relative to the vehicle [placebo].
The pool was of eligible patients who were aged 12 and older who had established atopic dermatitis consistent with the protocol. These patients had essentially mild to moderate atopic dermatitis based upon a global score, and they had to have a body surface area involving at least a minimum of a body surface area of 3%. A way to think of it is, someone's hand size is about 1% of their body. So they had to have a minimum of 3% body surface area involvement, up to 20% body surface area.
The major outcome measures that we use in these studies is what percentage of patients make it to clear or almost clear. And we actually make sure there's sort of a 2-step drop, so if they were only mild, they’ve got to sort of make it to clear. And the study showed that the people who just use the moisturizer part—the vehicle of the ruxolitinib—about 14% of those patients made it to clear or almost clear. In 8 weeks, we were close to 50% in the 2 ruxolitinib groups: 47.2% with the lower-strength cream used twice a day and 50.6% in those who used the higher-strength cream twice a day.
Another measure that was used was itch. Itch is a huge part of atopic dermatitis. There's a standard itch measure that's called the Numerical Rating Scale. Basically, patients are asked every day to say, what was your worst itch number in the last 24 hours, from 0 to 10, and baseline in this group was about 4.5 of 10. And the percentage of patients who had at least a 4-point drop in their itch, it was 52% in the higher-strength cream, in the mid-40s for the lower-strength cream, and only 17% of those using the vehicle.
One of the questions we want to know is if you use this, what's the side effect profile? Is it well tolerated? Is there stinging and burning? Because we do have some stinging and burning with some of our other nonsteroidal anti-inflammatories that we use for atopic dermatitis.