Tapinarof Cream Significantly Improves Atopic Dermatitis Regardless of Skin Color

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In a phase 3 trial that featured approximately half of participants with skin of color, tapinarof cream 1.0% provided consistent benefit for patients identified as White, Black, or Asian.

Tapinarof Cream Significantly Improves Atopic Dermatitis Regardless of Skin Color

Andrew Alexis, MD, MPH

A first-of-its-kind clinical trial including 50% representation of people of color in the treated participants arm showed approximately 4 in 10 treated patients with atopic dermatitis achieved a validated Investigators Global Assessment (vIGA) score of 0, indicating clear skin, with tapinarof cream 1% (VTAMA) at 8 weeks.1

The data from the pivotal phase 3 ADORING 1 and ADORING 2 trials, presented in a late-breaking session at the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, CA, this weekend, additionally showed a significantly greater proportion of treated patients were able to achieve Eczema Area Severity Index improvements of ≥75% (EASI 75) compared to the vehicle arm from baseline, regardless of skin color.

Tapinarof cream 1% is an aryl hydrocarbon receptor agonist previously approved by the US Food and Drug Administration (FDA) for the treatment of psoriasis. Investigation into its treatment of patients with atopic dermatitis has been headlined by the identical double-blind, randomized, vehicle-controlled ADORING trials, in which adults and children ≥2 years old with atopic dermatitis were randomized 2:1 to either once-daily tapinarof or vehicle cream for 8 weeks.

In the data presented by investigator Andrew Alexis, MD, MPH, vice-chair for diversity and inclusion for the department of dermatology and professor of clinical dermatology at Weill Cornell Medical College, at AAD 2024 this weekend, investigators had sought a primary efficacy endpoint of vIGA score of 0 or 1 and a ≥2-grade improvement from baseline to week 8. They additionally sought a secondary endpoint of proportion of patients to achieve EASI 75. Across both endpoints, investigators assessed patients stratified by race and ethnicity via Fitzpatrick skin type scoring.

Across the 2 trials, patient demographic ranges were as follows:

  • White, 44.8 – 56.8%
  • Black / African American, 26.5 - 35.0%
  • Asian, 8.8 - 15.3%
  • Other (American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or other/multiple races), 2.7 – 5.2%

Another 52.0 – 56.2% of patients across both studies were identified as either Fitzpatrick skin type IV, V, and VI—indicated as the most representative categories of skin of color.

In ADORING 1, 39.5% of Asian patients (n = 26) treated with tapinarof cream achieved vIGA 0 – 1 and 47.6% achieved EASI 75 by week 8. Among Black / African American patients (n = 70), 47.0% achieved vIGA 0 – 1 and 55.3% achieved EASI 75. Among White patients (n = 150), 17.5% and 30.0% achieved the primary and secondary endpoint, respectively.

In ADORING 2, 48.9% and 76.6% of treated Asian patients (n = 39) achieved vIGA 0 – 1 and EASI 75, respectively. Among Black / African American patients (n = 95), 43.1% and 48.9% achieved the primary and secondary endpoint, respectively. Among White patients (n = 124), 52.1% and 67.8% of patients achieved the primary and secondary endpoint, respectively.

Regarding safety, investigators reported that a majority of adverse events (AEs) were mild or moderate in severity. The most commonly reported AEs (≥5%) were folliculitis, headache, and nasopharyngitis.

In a statement accompanying the data, Alexis emphasized the reach and burden of atopic dermatitis across all skin types—as well as now the new promise of tapinarof cream 1.0% in capably treating such skin.2

“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,” Alexis said. “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.”

References

  1. Alexis A, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: An interim analysis of the open-label Phase 3b trial, ADmirable. Paper presented at: American Academy of Dermatology (AAD) 2024 Annual Meeting. March 8 – 12, 2024. San Diego, CA.
  2. Dermavant. 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. Press release. Published 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/
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