Drug Holidays Possible with Vtama in Atopic Dermatitis | AAD 2025

Patients as young as two years of age using Vtama (tapinarof), a nonsteroidal cream, to treat their atopic dermatitis were able to stop treatment and have their disease continue to be controlled, according to the results of the long-term, open-label study presented at the American Academy of Dermatology (AAD) Association annual meeting in Orlando, March 7, 2025, to March 11, 2025.

Atopic dermatitis is a chronic skin condition that causes inflammation, itching and dryness, as well as significantly impacting a person’s quality of life. Current treatments, such as topical corticosteroids, have side effects that limit their long-term use, especially in children.

Children with atopic dermatitis, especially younger children, don’t have a lot of options for treatment, Linda Stein Gold, M.D., director of Clinical Research and division head of Dermatology at Henry Ford Health, said in an interview. Stein Gold is one of the investigators who took part in the open-label extension trial of Vtama.

Vtama cream 1% is once daily therapy for adults and children as young as two years old with atopic dermatitis. The indication in children was approved in December 2024. Vtama was developed by Dermavant, which was acquired by Organon in October 2024.

The ADORING 3 study was a 48-week open-label, long-term extension study that enrolled 728 patients from the pivotal phase 3 ADORING 1 and ADORING 2 trials. The open-label portion also enrolled patients from a four-week pharmacokinetics study and patients 2 to 17 years of age with either mild, moderate, or severe atopic dermatitis that did not meet inclusion for clinical trials.

A unique aspect of the extension study was that it enrolled patients directly into the long-term, open-label portion, Stein Gold said. “These patients had mild disease, and more than 80% of those enrolled were pediatric patients. We have good data now looking at pediatric patients, including our youngest patients down to age two.”

The findings from the open-label study demonstrate atopic dermatitis activity remained mild in patients who had achieved treatment success and then entered a treatment-free interval lasting on average 80 days. Severity of disease was considered mild by investigator assessment and by the mean Eczema Area and Severity Index (EASI) score, a scale used to measure the extent and severity of atopic dermatitis.

More than 50% of those in the study at some point achieved completely clear skin, and more 80% got to clear or almost clear, and on average, they had 80 consecutive days of no treatment before their disease started to become mild or worse, Stein Gold said.

“The disease started to come back, but very slowly,” she said. “We're not having a rebound effect for the majority of these patients, but the disease seems to be able to get under control, and it looks like we can keep it under control with just one topical therapy.”

This is important, Stein Gold said, because topical steroids have some limitations and are limited for use on the face, sensitive skin or skin of color. “A nonsteroidal option that we can use anywhere on the body is nice. It’s important to simplify the treatment regimen. When we give patients too many things to do, it's just too hard to be compliant,” she said.

The study also found that itch, assessed with the patient-reported Peak Pruritus Numerical Rating Scale, remained low.

The most frequent treatment-emergent adverse events in ADORING 3 included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%); trial discontinuations due to treatment-emergent adverse events were low (2.6%).