New Phase 3 Data Shows High Rate of Atopic Dermatitis Clearance Using Tapinarof Cream 1%

Robert Bissonnette, MD

Credit: International Psoriasis Council

Treatment with tapinarof cream 1% (Vtama) for patients aged 2 years and older with atopic dermatitis leads to complete skin clearance among majority of patients within 48 weeks, according to findings from the ADORING 3 study presented at the 44th Annual Fall Clinical Dermatology Conference in Las Vegas.¹

Tapinarof cream, an aryl hydrocarbon receptor agonist, was evaluated in this study for the purposes of assessing its efficacy and safety among patients even as young as 2 years of age with atopic dermatitis. The findings followed the previous ADORING 1 and ADORING 2 studies.

“In the ADORING long-term extension study, (tapinarof) cream demonstrated a high rate of complete disease clearance, with more than half of enrolled adults and children entering with or achieving a vIGA-AD score of zero at least once, on monotherapy,” Robert Bissonnette, MD, FRCPC, Innovaderm Research’s chief executive officer, said in a statement. “Moreover, upon reaching complete disease clearance and ceasing treatment, patients stayed clear or almost clear for an average period of approximately 80 consecutive days.”

Atopic dermatitis is a chronic inflammatory skin disease which is among the most widespread skin conditions, affecting more than 26 million people in the US and approximately 10% of the global adult population. The disease is particularly common in children, however, with prevalence reaching up to 20% worldwide.

Tapinarof cream 1%, also known as Vtama, is an aryl hydrocarbon receptor agonist which has been approved by the US Food and Drug Administration (FDA) for individuals suffering from plaque psoriasis who are of adult age. It is currently being developed as a steroid-free, once-per-day topical option for the condition and its Supplemental New Drug Application (sNDA) nm in individuals aged 2 and older.²

To assess tapinarof cream in this age group, 2 identical phase 3 clinical studies, ADORING 1 and ADORING 2, had been previously conducted, with the investigators assessing subjects through the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scale.

In the new long-term, 48-week open-label study known as ADORING 3, these participants were followed from the initial research, though additional participants who were new to tapinarof aged 2–17 years with varying atopic dermatitis severity levels were added who had not met the criteria for ADORING 1 and ADORING 2 inclusion.

Those participating in ADORING 3 were monitored by the research team for up to 48 weeks, focusing safety outcomes on specific tolerability assessments by both patients and caregivers, treatment-related adverse events, and assessments of efficacy such as achieving complete disease clearance or near-clearance of disease.

Those known to have active symptoms (vIGA-AD≥1) used the topical cream until full resolution of the skin disease, after which these subjects discontinued the medication and were monitored for the duration of symptom-free intervals. Participants who reported mild or worse recurrence of their symptoms were retreated until remission successfully occurred.

Overall, the ADORING 3 findings reaffirmed the safety and tolerability profile of tapinarof cream that had been observed within ADORING 1 and ADORING 2. The team concluded that 51.9% of the 728 subjects either joined with or achieved complete clearance (vIGA-AD=0) over the course of the 48-week study.¹

Additionally, the investigators found that 81.6% either entered with or achieved ratings of clear or almost clear in terms of their skin (vIGA-AD=0 or 1) after using tapinarof. Those 378 who reported successful achievement of complete clearance were allowed to discontinue the topical cream to stay main treatment-free for an average of around 80 consecutive days.

“These results, combined with those from the ADORING 1 and ADORING 2 pivotal studies, demonstrate (tapinarof) cream’s potential ability to not only effectively and safely treat patients as young as 2 years of age with atopic dermatitis, but may also enable a majority to achieve complete disease clearance, and maintain either clear or almost clear skin for an average of over 2 and a half months while off all treatment,” Bissonnette said in a statement.¹

References

1. ^{Dermavant Presents ADORING 3 LTE Final Data on Complete Skin Clearance and Treatment-Free Interval for VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as Two Years Old with Atopic Dermatitis at the 44th Annual Fall Clinical Dermatology Conference. Dermavant Sciences. October 25, 2024. https://dermavant.com/dermavant-presents-adoring-3-lte-final-data-on-complete-skin-clearance-and-treatment-free-interval-for-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as-two-years-old-with-atopic-der/. Date accessed: October 25, 2024.}
2. ^{Dermavant Announces FDA Acceptance of Supplemental New Drug Application (sNDA) for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Dermavant Sciences. April 29, 2024. https://dermavant.com/dermavant-announces-fda-acceptance-of-supplemental-new-drug-application-snda-for-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-old/. Date accessed: October 25, 2024.}