Tapinarof Cream 1% Efficacious in Adults and Children With Skin of Color Down to 2 Years With AD

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Dermavant Sciences recently announced new data on the treatment of adult and pediatric patients with skin of color down to 2 years with atopic dermatitis (AD) with tapinarof cream 1% (Vtama) in its phase 3 ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) pivotal trials. The new data was presented at the 2024 American Academy of Dermatology Annual Meeting in San Diego, California.

In ADORING 1 (n=407) and ADORING 2 (n=406), 2 identical, double-blind, randomized, vehicle-controlled, pivotal phase 3 trials, patients were randomized 2:1 to receive tapinarof cream 1% once a day or vehicle once a day for 8 weeks.

The primary efficacy end point was the Validated Investigator Global Assessment for Atopic Dermatitis score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at week 8. The key secondary end points included the proportion of patients who achieved ≥75% improvement in the Eczema Area and Severity Index (EASI75).

Most notably, approximately 50% of patients enrolled in the phase 3 trials were patients with skin of color. Efficacy was reported by patient-reported race categories and investigator-assessed Fitzpatrick skin types in adults and children down to 2 years. In ADORING 1 and ADORING 2, 8.8% to 15.3% of patients were Asian, 26.5% to 35.0% of patients were Black/African American, 2.7% to 5.2% of patients were considered Other, which includes American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or other/multiple races), and 44.8% to 56.8% of patients were White.

"These results highlight the ability of Vtama cream, if approved by the FDA, to offer consistent and high efficacy across racial groups and Fitzpatrick skin type, underscoring the potential for Vtama cream to provide a meaningful difference for patients with skin of color who are typically an underrepresented patient population living with AD," Andrew Alexis, MD, MPH, Vice-Chair for Diversity and Inclusion for the Department of Dermatology and Professor of Clinical Dermatology at Weill Cornell Medicine, told Dermatology Times.

Fitzpatrick skin types IV-VI were the most representative of patient populations with skin of color in ADORING 1 and ADORING 2.

ADORING 1 Results

• 39.5% of Asian patients treated once daily with tapinarof (n=26) achieved the primary end point and 47.6% achieved the secondary end point, compared to 3.7% and 20.2% in the vehicle (n=10) group
• 47.0% of Black patients treated once daily with tapinarof (n=70) achieved the primary end point and 55.3% achieved the secondary end point, compared to 17.5% and 30.0% in the vehicle (n=38) group
• 49.4% of White patients treated once daily with tapinarof (n=152) achieved the primary end point and 61.4%achieved the secondary end point, compared to 12.2% and 19.6% in the vehicle (n=79) group

ADORING 2Results

• 48.9% of Asian patients treated once daily with tapinarof(n=39) achieved the primary end point and 76.6% achieved the secondary endpoint, compared to 18.5% and 17.7% in the vehicle (n=23) group
• 43.1% of Black patients treated once daily with tapinarof (n=95)achieved the primary end point and 48.9% achieved the secondary endpoint, compared to 24.1% and 25.7% in the vehicle (n=47) group
• 52.1% of White patients treated once daily with tapinarof (n=124) achieved the primary end point and 67.8% achieved the secondary end point, compared to 14.5% and 20.7% in the vehicle (n=58) group

In ADORING 1, 57.1% of patients with Fitzpatrick skin type IV-VI achieved an EASI75 response at week 8. In ADORING 2, 58.1% of patients with Fitzpatrick skin type IV-VI achieved an EASI75 response at week 8.

"There are a number of special considerations for AD in patient populations with skin of color in the US including a higher prevalence of AD in Black children vs. White children (15.89% vs. 9.7%), higher odds of persistence of AD from early- to mid-childhood in Black children vs. White children, higher rates of absenteeism from school secondary to AD among Black and Hispanic children, and racial/ethnic disparities in health care utilization rates among AD patients. In addition, patients with AD and more pigmented skin – skin of color – also tend to present with associated pigment alterations such as hyper- and hypo-pigmentation as long-term sequelae of their AD. This contributes to the overall burden and impact of AD on patients with skin of color," Alexis told Dermatology Times.

Any adverse events reported in the ADORING trials were mild to moderate, with the most frequent (≥5% in any group) being folliculitis, headache, and nasopharyngitis.

“Atopic dermatitis is a dermatological condition that can affect people from all racial and ethnic backgrounds and skin types. 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,” said Alexis in the news release. “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. This is an example of innovation that may help clinicians improve the treatment journey for patients with atopic dermatitis.”

Reference

Dermavant presents new data on treatment of patients with skin of color from ADORING 1 and ADORING 2 phase 3 pivotal trials of Vtama (tapinarof) cream, 1% in adults and children 2 years of age and older with atopic dermatitis at the 2024 American Academy of Dermatology Annual Meeting. March 8, 2024. Accessed March 8, 2024. https://www.dermavant.com/dermavant-presents-new-data-on-treatment-of-patients-with-skin-of-color-from-adoring-1-and-adoring-2/