Recently Approved Atopic Dermatitis Therapy Demonstrates Efficacy, Safety

Vivian Shi, MD, FAAD, associate professor of dermatology, University of Arkansas for Medical Sciences, provides an overview of a recently approved treatment for atopic dermatitis.

Listen to the full series here.

Read the full transcript: 

Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more.

In the second part of this podcast series, Dr Shi provides an in-depth look at a treatment for atopic dermatitis.

Hello, my name is Vivian Shi, I'm a board-certified dermatologist practicing in Little Rock, Arkansas. I'm currently an academic dermatologist and associate professor of dermatology at the University of Arkansas for Medical Sciences where I direct the clinical trials operation in my department. I specialize in atopic dermatitis as well as other inflammatory conditions such as hidradenitis suppurativa.

How does Rux cream differ from other therapies on the market?

Rux cream is kind of a novel topical product. We had heard about JAK inhibitors for a long time in the rheumatologic space. In the oncology space they're used, for example, for solid organ transplants or rejections or graft vs host disease, but in dermatology, this is quite novel. Rux is a JAK inhibitor, which is a small molecule inhibitor that blocks the JAK-STAT pathway used in atopic dermatitis cytokines for signaling.

Th2 cytokines bind to their respective receptors on the cells. Then that usually activates a heterodimer or a homodimer, that's a JAK family. There are 4 JAK families—JAK 1, 2, 3, and Tyk2. This activation alters the transcription of inflammatory cytokines. What these JAK inhibitors do is to block that signaling, ultimately decreasing Th2 inflammation and allowing the skin barrier to heal and decrease itch.

We have oral JAK inhibitors, but topical inhibitors are important to think about. In order for medication to diffuse through the skin and be able to spark an anti-inflammatory property, it has to be less than 500 Dalton. That's pretty small. These JAK inhibitors are that small. It’s able to get through the skin surface into the upper dermis and the blood vessels to combat inflammation.

It's the first of its kind in dermatology and certainly for atopic dermatitis. It’s really offering a novel and quite effective option for topical treatments. Maybe people who would have otherwise been needing systemic treatments could now use Rux cream. It's so robust as a topical product and potentially delays or negates the need for systemic treatment.

For which patients do providers commonly recommend Rux cream?

Well, it's recently approved so we're learning as we speak. It's basically people who have atopic dermatitis in an area where topical corticosteroids is not indicated. This is commonly the face, eyelid, intertriginous areas, and also if other nonsteroidal anti-inflammatories may be contraindicated or not effective. These include your topical calcineurin inhibitors such as tacrolimus and pimecrolimus, crisaborole ointment.

The one beauty that we see, at least from the clinical trials, is Rux cream doesn't appear to have much application site discomfort. This is common in topical calcineurin inhibitors and crisaborole, where you already have a very inflamed eczema spot and you apply this cream, and both active and inactive ingredients cause excessive burning. You lose the patient very quickly, especially children. They will never want to use a cream that burns on their active eczema. It seems like with Rux cream, the formulation is better tolerated than other nonsteroidal anti-inflammatory medications.

Heading more toward the safety profile from there, can you comment on the efficacy and safety of Rux cream?

Yes. If you look at the phase 3 trials, these are patients with mild to moderate atopic dermatitis. They were randomized to either receive placebo or .75% or 1.5% of the Rux cream, and the primary endpoint is assessed at week 8. When you look at the active arm vs a placebo, a significantly higher proportion of patients receiving Rux cream reached endpoint. The endpoints are clear or almost clear skin, or at least 2-point greater improvement in the Investigator Global Assessment score. The patient-reported outcome measure is the itch interest of 4 points or greater reduction.

If you look at the active arm, we're looking at over 50% achieving these endpoints. With placebo, we're looking at about 15% or so. Very big difference. There's no head-to-head yet. Let me just preface that. There's no head-to-head trial looking at how Rux cream compared to other nonsteroidal anti-inflammatories, but just looking at the data here, it is more robust, it's more efficacious, even at just week 8. That's a 2-month period. It's pretty short. It's pretty fast.

Thanks for tuning in to another episode of PopHealth Perspectives. For similar content or to join our mailing list, visit populationhealthnet.com.