© 2024 MJH Life Sciences™ and Patient Care Online. All rights reserved.
Tapinarof Cream 1.0% Effective for Atopic Dermatitis in Persons with Skin of Color: ADORING Phase 3 Program
Study participants self-identified as Black, White, or Asian and significant proportions reached improvement of ≥75% in EASI in both in ADORING 1 and ADORING-2.
Tapinarof cream 1% was associated with statistically significant improvement in atopic dermatitis in twin phase 3 studies that each included more than 50% of participants with skin of color.
According to findings from the pivotal ADORING 1 and ADORING 2 clinical trials, approximately 4 in 10 participants who identified as White, Black, and Asian achieved a validated Investigators Global Assessment (vIGA) score of 0, indicating clear skin, with tapinarof cream 1% after 8 weeks of treatment.
Data from the pair of novel studies also showed a significantly greater proportion of participants treated with once-daily tapinarof cream 1% achieved Eczema Area Severity Index improvements of ≥75% (EASI 75) compared to those treated with the vehicle cream from baseline, regardless of skin color.
The findings were presented during a late-breaking session at the American Academy of Dermatology (AAD) 2024 Annual Meeting, held March 8-12 in San Diego, CA, by 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.
“Atopic dermatitis is a dermatological condition that can affect people from all racial and ethnic backgrounds and skin types,” Alexis said in a statement from product manufacturer Dermavant. “Treating diverse participants 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.”
“Treating diverse participants 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.”
Tapinarof cream 1% is an aryl hydrocarbon receptor agonist previously approved by the US Food and Drug Administration (FDA) in 2022 for the treatment of mild, moderate, and severe plaque psoriasis, according to a statement from product manufacturer Dermavant. The formulation being studied in the ADORING phase 3 development program for atopic dermatitis is the same strength currently used for psoriasis treatment.
ADORING-1, ADORING-2
ADORING 1 and ADORING 2 were identical double-blind, randomized, vehicle-controlled studies in which adults and children aged 2 years and older were randomly assigned to in 2:1 ratio to once daily treatment with tapinarof 1.0% or vehicle cream for 8 weeks.
For both studies, investigators specified the primary efficacy endpoint as vIGA score of 0 or 1 and at least a 2-grade improvement from baseline to week 8. The secondary endpoint was the proportion of study participants who achieved an improvement of 75% or greater on EASI 75. The data reflect tapinarof efficacy by race categories as reported by study participants and by Fitzpatrick skin type as assessed by study investigators. scoring.
Baseline demographics across the 2 phase 3 trials, according to the study:
- 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%
Participants with Fitzpatrick skin types IV, V, and VI, described as most representative of populations with skin of color, represented another 52.0 – 56.2% across both studies, with the greatest proportion having type IV and the smallest having type VI.
In ADORING 1:
- 39.5% of Asian participants (n = 26) treated with tapinarof cream achieved vIGA 0 – 1 and 47.6% achieved EASI 75 by week 8.
- Among Black / African American participants (n = 70), 47.0% achieved vIGA 0 – 1 and 55.3% achieved EASI 75.
- Among White participants (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 participants (n = 39) achieved vIGA 0 – 1 and EASI 75, respectively.
- Among Black / African American participants (n = 95), 43.1% and 48.9% achieved the primary and secondary endpoint, respectively.
- Among White participants (n = 124), 52.1% and 67.8% of participants achieved the primary and secondary endpoint, respectively.
The majority of adverse events (AEs) were mild or moderate in severity. The most commonly reported AEs (≥5%) were folliculitis, headache, and nasopharyngitis, according to the statement.
“Today’s data on treatment of participants with skin of color highlight VTAMA cream’s promise across all racial groups and skin types in the pivotal trials,” concluded Alexis.
On February 14, 2024, Dermavant submitted a supplemental New Drug Application (sNDA) to the FDA for tapinarof cream, 1% for the treatment of AD in adult and children aged 2 years and older.
ADORING-3, a 48-week open-label, long-term extension study, is ongoing and rounds out the phase 3 clinical trial program of tapinarof cream 1% in treatment of atopic dermatitis.
