New data from the ADORING 3 study, presented at the 44th Annual Fall Clinical Dermatology Conference, reveals that tapinarof cream 1% (Vtama) leads to complete skin clearance in a majority of atopic dermatitis patients aged 2 years and older within 48 weeks. The study assessed the efficacy and safety of tapinarof, an aryl hydrocarbon receptor agonist, in this patient population.
High Rate of Disease Clearance
The ADORING 3 long-term extension study demonstrated a high rate of complete disease clearance, with over half of enrolled adults and children achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of zero at least once on monotherapy, according to Robert Bissonnette, MD, FRCPC, CEO of Innovaderm Research. Furthermore, patients who achieved complete disease clearance and ceased treatment remained clear or almost clear for an average of approximately 80 consecutive days.
Atopic Dermatitis Burden and Tapinarof Potential
Atopic dermatitis, a chronic inflammatory skin disease, affects more than 26 million people in the US and approximately 10% of the global adult population. Prevalence is particularly high in children, reaching up to 20% worldwide. Tapinarof cream 1%, already FDA-approved for plaque psoriasis in adults, is being developed as a steroid-free, once-per-day topical option for atopic dermatitis. The FDA has accepted the Supplemental New Drug Application (sNDA) for tapinarof cream for atopic dermatitis in individuals aged 2 and older.
ADORING 3 Study Design and Results
The ADORING 3 study followed participants from the ADORING 1 and ADORING 2 phase 3 clinical studies, with additional participants aged 2–17 years added who had not met the criteria for the initial studies. Participants were monitored for up to 48 weeks, with a focus on safety outcomes, tolerability, treatment-related adverse events, and efficacy, including complete or near-clearance of disease. Patients with active symptoms (vIGA-AD ≥1) used the topical cream until full resolution, then discontinued medication and were monitored for symptom-free intervals. Those with recurrence of symptoms were retreated until remission.
The study found that 51.9% of the 728 subjects either joined with or achieved complete clearance (vIGA-AD=0) over the 48-week study period. Additionally, 81.6% either entered with or achieved ratings of clear or almost clear skin (vIGA-AD=0 or 1) after using tapinarof. Of the 378 participants who achieved complete clearance, they were able to remain treatment-free for an average of approximately 80 consecutive days.
Implications for Atopic Dermatitis Treatment
According to Dr. Bissonnette, these results, combined with those from the ADORING 1 and ADORING 2 pivotal studies, demonstrate tapinarof cream’s potential to effectively and safely treat atopic dermatitis patients as young as 2 years of age. The treatment may also enable a majority of patients to achieve complete disease clearance and maintain clear or almost clear skin for an average of over two and a half months while off all treatment. The ADORING 3 findings reaffirmed the safety and tolerability profile of tapinarof cream observed in the earlier ADORING 1 and ADORING 2 studies.
