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Tapinarof Cream 1% Once Daily Shows Consistent Efficacy Across All Body Regions
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Key Takeaways
- Tapinarof cream 1% shows consistent efficacy across all body regions, including sensitive areas, in treating moderate-to-severe atopic dermatitis.
- Phase 3 ADORING trials demonstrated significant improvements in disease severity and pruritus with tapinarof compared to vehicle.
Efficacy and tolerability of topical treatments can vary by region, particularly sensitive areas such as the face and neck.
New data presented at the American Academy of Allergy, Asthma, and Immunology/World Allergy Organization (AAAAI/WAO) Joint Congress demonstrate that when used once daily, tapinarof cream 1% (Vtama; Dermavant) shows consistent efficacy across all body regions, including the head and neck, in adults and children as young as 2 years of age.1
Tapinarof is an aryl hydrocarbon receptor agonist, which is a transcription factor that affects immune-mediated skin responses. It is a nonsteroidal cream that can be used on sensitive skin for longer periods of time without limitations on the total area of skin treated.2
Tapinarof is an aryl hydrocarbon receptor agonist | Image credit: Ladanifer | stock.adobe.com
According to the pivotal phase 3 ADORING trials, tapinarof has demonstrated significant efficacy and favorable safety and tolerability in a diverse population of patients as young as 2 with atopic dermatitis. In the study, 813 patients were randomly assigned to tapinarof or vehicle once daily in two 8-week phase 3 trials.3
The primary end point of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and a 2-grade or better improvement from baseline at week 8 was met, with statistical significance in both trials (45.4% vs 13.9% and 46.4% vs 18% for tapinarof vs vehicle, respectively). Superior responses to the Eczema Area and Severity Index 75 (EASI-75) were also observed with tapinarof versus vehicle at week 8 (55.8% vs 22.9% and 59.1% vs 21.2%). Investigators also noted rapid improvements in patient-reported pruritus with tapinarof versus vehicle.3
Common adverse events (AEs; ≥5%) included folliculitis, headache, and nasopharyngitis and were mostly mild or moderate. There were fewer discontinuations due to AEs in the tapinarof groups than with vehicle.3
In the new data presented at AAAAI/WAO, researchers delved into a closer analysis of body regions because efficacy and tolerability of topical treatments can vary by region, particularly sensitive areas such as the face and neck. The investigators presented EASI scores by body region.1
According to the analysis, mean baseline EASI scores were between 12.2 and 13.5 (standard deviation 4.7-5.6), indicating moderate-to-severe atopic dermatitis. Achievement of 75% or better improvement in EASI at week 8 for tapinarof versus vehicle was 55.8% vs 22.9% and 59.1% vs 21.2% in ADORING 1 and 2, respectively. At week 8, least squares (LS) mean overall EASI score improvements from baseline were -8.4 vs -4.1 and -10.1 versus -5.2.
Furthermore, LS mean changes in EASI scores by body region at week 8 were -8.7 versus -4.4 and -8.8 versus -4.7 for head/neck; -5.9 versus -2.6 and -7.2 versus -3.8 for trunk; -12 versus -5.2 and -15 versus -6.6 for upper extremities; and -8.6 versus -4.4 and -9.9 versus -5.5 for lower extremities. Tapinarof was well tolerated across sensitive areas, including the face and neck.1
The findings from the ADORING trials and the subsequent analysis presented at AAAAI/WAO demonstrate that tapinarof cream 1% provides significant clinical benefits for patients with moderate-to-severe atopic dermatitis. The ability to achieve substantial improvements in disease severity across all body regions, including areas often challenging to treat, highlights the potential for tapinarof to improve patients’ quality of life.
Furthermore, the favorable safety and tolerability profile, with low rates of AEs and discontinuations, suggests that tapinarof can be used effectively for long-term management. These results have important implications for clinical practice, offering a valuable nonsteroidal option for patients with atopic dermatitis.
