In a patient population with diverse skin tones, tapinarof cream, 1% (VTAMA®, Dermavant) was shown to have significant efficacy in both adults and children as young as 2 years of age with atopic dermatitis (AD), according to new results presented at the 2024 American Academy of Dermatology Annual Meeting in San Diego.
“Today’s data on treatment of patients with skin of color highlight VTAMA cream’s promise across all racial groups and skin types in the pivotal trials,” Andrew F. Alexis, MD, MPH, a clinical professor of dermatology at Weill Cornell Medicine and a practicing dermatologist at New York Presbyterian/Weill Cornell Medical Center, said in a news release. “This is an example of innovation that may help clinicians improve the treatment journey for patients with atopic dermatitis.”
Researchers for the identical ADORING 1 (n = 407) and ADORING 2 (n = 406) pivotal phase 3 trials randomly assigned patients 2:1 to receive either tapinarof cream once daily or to vehicle for 8 weeks. The primary efficacy endpoint was the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) of 0 (clear), 1 (almost clear), and ≥2-grade improvement from baseline at Week 8, with secondary endpoints of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI75). More than 50% of the patients enrolled across the two studies had skin of color.
According to the results presented at the meeting, which reported efficacy by patient-reported race categories and investigator-assessed Fitzpatrick skin types among adults and children ≥2 years of age, 57.1% and 58.1% of patients with Fitzpatrick skin type (IV, V, VI) achieved EASI75 response at week 8, respectively.
“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,” said Philip M. Brown, MD, JD, chief medical officer at Dermavant, in a news release. “Importantly, approximately 50% of patients who enrolled in the ADORING pivotal trials had skin of color, a particularly high representation in clinical trials. 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 with AD.”
Adverse events in the trials were reported as mostly mild or moderate and included folliculitis (most common), headache, and nasopharyngitis.