Vtama Effective in Atopic Dermatitis, Including Skin of Color | AAD 2024

New data on Vtama (tapinarof) cream 1% show it is effective in treating atopic dermatitis in children 2 years and older, including those with skin of color, according to a presentation at the American Academy of Dermatology (AAD) annual meeting. 

Atopic dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Black children are approximately 1.7 times more likely to develop atopic dermatitis than White children, and Black and Hispanic children are more likely to experience severe disease.

Additionally, in people with color, atopic dermatitis can result in pigment and dry skin that is more visible in dark skin.

Andrew F. Alexis, M.D.

There is an unmet need for this patient population because clinical trials often don’t reflect the diversity of the disease population. There are minimal data on atopic dermatitis treatment in patients with skin of color, Andrew F. Alexis, M.D., MPH, vice-chair for Diversity and Inclusion for the Department of Dermatology and professor of Clinical Dermatology at Weill Cornell Medicine, said during the presentation. He indicated there is a need for efficacious topical therapies that can be used without restrictions relating to duration or extent of use, or site of application by people with skin of color.

“Treating diverse patients involves recognizing nuances in specific populations, which historically has been hampered by a lack of data for people of color, exacerbated by their underrepresentation in clinical trials,” he said .

Developed by Dermavant Sciences, Vtama is a non-steroid cream that targets the aryl hydrocarbon receptor and modifies the expression of interleukin-17. It was approved in May 2022 to treat plaque psoriasis in adults. Last month, the company submitted a supplemental new drug application (sNDA) to the FDA to treat atopic dermatitis in individuals or older.

The sNDA was based based on data from the identical phase 3 ADORING 1 and ADORING 2 trials. Together, the two trials enrolled 813 patients; approximately half were either Black/African American, Asian or individuals in other groups, including American Indian, Alaska Native, Native Hawaiian and Pacific Islanders.

Patients received Vtama once daily or vehicle for eight weeks. The primary efficacy endpoint was the Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 (meaning clear or almost clear skin) and a 2-grade or higher improvement from baseline at week 8. Secondary endpoints in included the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index.

Investigators found that Vtama was efficacious across the range of racial categories and investigator-assessed Fitzpatrick skin types, which is a way to classify skin by its exposure to the sun.

In ADORING-1, 49.4% of White patients who received Vtama achieved the primary endpoint of clear or almost clear skin. Among people of color, 47% Black patients achieved clear or almost clear skin; 39.5% of Asian patients achieved this endpoint. In ADORING-2, 52.1% of White patients, 43.1% of Black patients and 48.9% of Asian patients achieved clear or almost clear skin.

Adverse events were mostly mild or moderate; the most frequent were folliculitis (inflamed hair follicles on the skin), headache, and nasopharyngitis.