Dermavant’s Tapinarof cream 1% shows efficacy in atopic dermatitis for people of color
18 Mar 2024 --- Dermavant Sciences unveils phase 3 trial data on atopic dermatitis treatment in patients with skin of color with VTAMA (Tapinarof) cream 1%.
The immuno-dermatology-focused biopharmaceutical company demonstrates the statistically significant efficacy of the VTAMA cream in treating atopic dermatitis in adults and children as young as two years old.
Approximately 50% of enrolled patients had skin of color in the trial — “a particularly high representation in clinical trials.”
The findings were released at the 2024 American Academy of Dermatology Annual Meeting.
Significant improvement
In two double-blind tests of around 407 patients, 57.1% and 58.1% of patients with Fitzpatrick skin types (IV, V and VI) achieved a 75% improvement in the eighth week, measured using the Eczema Area and Severity Index.
“The data on treatment of patients with skin of color presented today at the AAD annual meeting is extremely promising, as it highlights VTAMA cream’s ability to achieve consistent and strong efficacy across all racial groups, including patients with skin of color,” says Philip Brown, MD, JD, chief medical officer at Dermavant.
“Based on the results we have reported thus far, we are enthusiastic about VTAMA cream’s potential, and if approved by the FDA for atopic dermatitis, we believe that VTAMA cream will make a meaningful difference for the diverse patient population suffering from atopic dermatitis.”
The trials enrolled patients with diverse backgrounds. Key demographic breakdowns include:
- Asian: 8.8% – 15.3%.
- Black/African American: 26.5% – 35.0%.
- Other groups: 2.7% – 5.2%.
- White: 44.8% – 56.8%.
“Atopic dermatitis is a dermatological condition that can affect people from all racial and ethnic backgrounds and skin types,” says Andrew F. Alexis, MD, MPH, vice-chair for Diversity and Inclusion for the Department of Dermatology, professor of Clinical Dermatology at Weill Cornell Medicine and a dermatologist at New York-Presbyterian/Weill Cornell Medical Center.
“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 highlights.
“Today’s data on treatment of patients with skin of color highlights VTAMA cream’s promise across all racial groups and skin types in the pivotal trials. This is an example of innovation that may help clinicians improve the treatment journey for patients with atopic dermatitis.”
Cream’s profile
The FDA initially approved VTAMA cream for plaque psoriasis in 2022. It became the first non-steroidal topical novel chemical launched for psoriasis in the US in over 25 years, highlgihts Dermavant.
Last month, the company submitted an application to the FDA for the VTMA cream treatment of atopic dermatitis in adults and children two years of age and older, which is currently under review.
According to Dermavant, VTAMA cream 1% has shown a safety profile, with the most common adverse reactions that may affect less than 1% of users with folliculitis, nasopharyngitis, contact dermatitis, headache, itching and influenza.
By Venya Patel
