Vtama cream achieves consistent efficacy in atopic dermatitis across racial groups

March 09, 2024

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Key takeaways:

• 50% of patients identified as having skin of color.
• In ADORING 1 and ADORING 2, 57.1% and 58.1% of patients, respectively, with skin types I to III and IV to VI achieved EASI 75 at week 8.

SAN DIEGO — New data showed Vtama cream achieved consistent and strong efficacy for the treatment of atopic dermatitis across all racial groups, according to a poster presentation at the 2024 American Academy of Dermatology Annual Meeting.

Dermavant Sciences announced new data from its phase 3 ADORING 1 and ADORING 2 pivotal trials evaluating Vtama (tapinarof) cream 1%, a steroid-free topical, in adults and children aged as young as 2 years with AD.

New data showed Vtama cream achieved consistent and strong efficacy for the treatment of atopic dermatitis across all racial groups. Image: Adobe Stock.

With approximately 50% of patients enrolled in the study having skin of color, the new data report efficacy by patient-reported race categories.

Andrew F. Alexis

“On the whole, patients with skin of color have been underrepresented in clinical trials of AD, which has contributed to data and knowledge gaps related to the treatment of AD in our diverse patient population,” Andrew F. Alexis, MD, MPH, FAAD, vice chair for diversity and inclusion for the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, told Healio. “Ensuring diversity in clinical trials, in dermatology and beyond, is crucial for ensuring treatments are effective for all patients, regardless of race, ethnicity or skin type.”

Of the 407 and 406 patients in ADORING 1 and ADORING 2, respectively, 8.8% to 15.3% were Asian; 26.5% to 35% were Black/African American; 2.7% to 5.2% were other groups, including American Indian, Alaska Native, Native Hawaiian, Pacific Islander, or other/multiple races; and 44.8% to 56.8% were white. Each patient was randomly assigned to receive Vtama cream or vehicle once daily for 8 weeks.

In ADORING 1, 44.8% of patients with Fitzpatrick skin types I to III and 49.6% of patients with skin types IV to VI treated with Vtama achieved the primary endpoint of a validated IGA-AD score of 0 or 1 and at least a 2-grade improvement from baseline at week 8. In contrast, the same was achieved by 13.5% and 15.3% of the respective vehicle groups. EASI 75 was also achieved by 59.6% and 57.1% of the skin types I to III and IV to VI groups, respectively, vs. 22.3% and 24.6% of vehicle groups.

Similar results were seen in ADORING 2, with 49.9% of patients with skin types I to III and 46.8% of patients with skin types IV to VI achieving the primary endpoint vs. 17.7% and 19.5% of vehicle groups. EASI 75 was achieved by 66% and 58.1% of skin types I to III and IV to VI groups, respectively, vs. 20.1% and 23% of the vehicle groups.

Treatment-emergent adverse events in both trials were reported as mostly mild or moderate with the most frequent being folliculitis, headache and nasopharyngitis. Also, there was no hypopigmentation reported.

As Healio previously reported, while Vtama cream 1% is currently approved for the treatment of plaque psoriasis in adults, its supplemental new drug application for AD in adults and children aged 2 years and older, submitted on Feb. 13, is currently being reviewed by the FDA.

“The findings highlight the ability of Vtama cream, if approved by the FDA, to offer consistent and high efficacy across racial groups and Fitzpatrick skin types, 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,” Alexis told Healio.

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Sources/Disclosures

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Disclosures:
Alexis reports having financial relationships with AbbVie, Aerolase, Allergan, Almirall, Alphyn, Amgen, Apogee, Arcutis, Avita Medical, Bausch Health, Beiersdorf, Bristol Myers Squibb, Canfield, Cara, Castle, Cutera, Dermavant Sciences Inc., Eli Lilly, EPI Health Inc., Galderma, Incyte, Johnson & Johnson, Janssen, L’Oréal, LEO Pharma, Ortho, Pfizer, Regeneron, Sanofi-Genzyme, Sanofi-Regeneron, Springer, Swiss American, UCB Pharma, VisualDx, Vyne, Wiley-Blackwell and Wolters Kluwer Health. Please see the poster for all other authors’ relevant financial disclosures.

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