Dermavant Sciences has announced positive long-term results from the ADORING 3 extension study evaluating Vtama (tapinarof) cream for the treatment of atopic dermatitis (AD) in adults and children as young as two years old. The data, presented at the Annual Fall Clinical Dermatology Conference, highlight the potential of Vtama cream to achieve complete disease clearance and sustain treatment-free intervals in AD patients.
ADORING 3 Study Details
The ADORING 3 study enrolled patients from the ADORING 1 and ADORING 2 trials, as well as Vtama cream-naive patients aged two to 17 years with mild, moderate, or severe AD. The 48-week extension study assessed the long-term efficacy and safety of Vtama cream.
Key Findings
The results showed that 51.9% of patients achieved complete disease clearance at least once during the study. Furthermore, 81.6% of patients achieved either clear or almost clear skin at least once during the 48-week period. Among patients who achieved complete disease clearance and discontinued Vtama, the average duration of the first treatment-free interval was 79.8 consecutive days. Re-treatment with Vtama led to complete clearance in patients whose disease returned to mild or above.
Clinical Implications
Robert Bissonnette, chief executive officer at Innovaderm Research, commented on the data, stating, "These results, combined with those from the ADORING 1 and 2 pivotal studies, demonstrate Vtama cream’s potential ability to not only effectively and safely treat patients as young as two years of age with AD, but may also enable a majority to achieve complete disease clearance, and maintain either clear or almost clear skin for an average of over two and a half months while off all treatment."
Regulatory Status
The US Food and Drug Administration (FDA) has accepted Dermavant’s supplemental new drug application (sNDA) for Vtama in AD, with a decision expected in the fourth quarter of this year. Atopic dermatitis, also known as eczema, affects over 26 million people in the US and up to 10% of adults and 20% of children worldwide. Vtama is already approved for plaque psoriasis.
