FDA Approves Steroid-Free Cream for Atopic Dermatitis

Key Takeaways

• Zoryve (roflumilast) cream 0.15 percent can help improve itch, the most bothersome atopic dermatitis symptom, in as soon as 24 hours.
• Side effects were minimal and mild in clinical trials.
• Because it's steroid-free, Zoryve cream 0.15 percent can be used for as long as needed.

The U.S. Food and Drug Administration (FDA) has approved Zoryve (roflumilast) cream 0.15 percent for adults and children ages 6 or older with mild to moderate atopic dermatitis , the most common type of eczema . A once-daily topical treatment, Zoryve works quickly and with fewer side effects than other options, and it can be used for any length of time.

Although many with mild to moderate atopic dermatitis find their symptoms improve with regular moisturizing and self-care, others need stronger treatments.

"The mainstay of treatment for atopic dermatitis for decades has been topical steroids, which are not safe for long-term use, and topical calcineurin inhibitors, which are often not tolerable due to a burning sensation," says Ray Kleinfelder, DO , a dermatologist based in Santa Barbara, California, who treats atopic dermatitis.

Zoryve allows providers to offer continuous treatment to patients whose symptoms aren't well-managed with standard options like moisturizers or other prescription topical treatments, says the pediatric dermatologist Lawrence Eichenfeld, MD , a professor of clinical dermatology at the University of California in San Diego and coauthor of the clinical trials for roflumilast cream 0.15 percent.

A phosphodiesterase 4 (PDE4) inhibitor, Zoryve works by inhibiting enzymes that mediate inflammation in the skin, which means it helps block inflammation before it starts, says Dr. Eichenfeld. "And Zoryve allows us to then control atopic dermatitis with a new kind of medicine that doesn't rely upon topical corticosteroids ... [and uses] a very well designed moisturizer base that can still deliver a potent anti-inflammatory medicine."

Topical steroid creams can be problematic in certain parts of the body, like the sensitive skin around the eyes, says Eichenfeld. But, Zoryve can be applied anywhere on the skin with a very low chance of side effects.

Atopic dermatitis is the newest indication for Zoryve, which was already FDA approved in a higher concentration (0.3 percent) for plaque psoriasis in a cream formulation and for seborrheic dermatitis ( scalp eczema ) in a foam formulation.

Zoryve May Improve Itch as Soon as 24 Hours After Use

In phase 3 clinical trials, called INTEGUMENT-1 and INTEGUMENT-2, participants with atopic dermatitis were randomly assigned to apply either roflumilast cream 0.15 percent (for the treatment group) or "vehicle" (an inactive cream for the control group) daily for four weeks. Roflumilast cream was found to work rapidly compared with vehicle, helping improve itch as quickly as 24 hours after use.

After four weeks, participants assigned to roflumilast cream experienced significantly greater symptom reduction - including improved itch and clearer skin - than those assigned to vehicle. The researchers measured this using three scales: the Validated Investigator Global Assessment–Atopic Dermatitis (vIGA-AD) score, the Worst Itch-Numeric Rating Scale (WI-NRS), and the Eczema Area and Severity Index (EASI).

The vIGA-AD scores eczema symptoms from 0 (no symptoms) to 4 (severe symptoms).

The WI-NRS measures itching on a numerical scale, where zero equals no itching and 10 equals severe itching.

The EASI scale measures how much of the skin is affected by eczema, as well as the severity of symptoms.

Researchers further studied the long-term effects of roflumilast cream in the 56-week INTEGUMENT-OLE long-term open-label study. Participants treated with roflumilast cream had continued improvements in itch and other symptoms through 56 weeks of treatment.

Side Effects Were Uncommon in Clinical Trials

Overall, researchers found that Zoryve had minimal side effects. Less than 3 percent of phase-3 trial participants experienced side effects. The most common ones were headache , nausea, pain at the site of application, diarrhea, and vomiting.

"Any patient could have a potential reaction to a newly prescribed medication," says Dr. Kleinfelder, who was not involved with the clinical trials for roflumilast cream 0.15 percent. "Fortunately, the data on these nonsteroidal agents is very promising for long-term safety."

When Will Zoryve Be Available?

You can ask your healthcare provider about Zoryve right away, says Eichenfeld. It's expected to be available for purchase by the end of July, according to Arcutis Biotherapeutics, the manufacturer of Zoryve.

The new cream will likely come at a cost similar to that of the higher dosage Zoryve cream, but the exact cost will likely depend on your insurance coverage, says Kleinfelder. People looking to try this new medication may face a high price tag at the pharmacy counter, he notes.

"Due to the amount of research backing the development, these new, branded topicals tend to be very expensive," says Kleinfelder. "While many insurance plans will be able to provide some sort of coverage or coupon, some patients may not be able to obtain these medications for a reasonable cost."

Still, Kleinfelder says, he plans to prescribe it to his patients. "I have already been using the higher-strength roflumilast for my psoriasis and seborrheic dermatitis patients and have no hesitation to prescribe to my atopic dermatitis patients," he says. "There are very few nonsteroidal agents approved for pediatric patients, so having this approval down to 6 years old will give us a new, safe option to treat these patients with long-term atopic dermatitis."

To help with cost, Arcutis Biotherapeutics offers the The Zoryve Direct Program to help patients access their prescribed medication. This includes the Zoryve Direct Savings Card Program , which is intended to help lower out-of-pocket costs for eligible patients with commercial health insurance. For financially eligible patients who are uninsured or underinsured, Arcutis Biotherapeutics offers the Arcutis Cares patient assistance program to provide Zoryve at no cost.

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Sources

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