Dermavant announces positive long-term results for Vtama cream in atopic dermatitis

Dermavant Sciences has announced encouraging long-term findings for its Vtama (tapinarof) cream, which is approved for plaque psoriasis, in treating atopic dermatitis (AD) in both adults and children as young as two years old.

Atopic dermatitis, commonly known as eczema, is a prevalent inflammatory skin condition affecting over 26 million individuals in the United States and up to 10% of adults and 20% of children worldwide. Dermavant previously shared positive outcomes from its phase 3 ADORING 1 and ADORING 2 trials. These trials assessed the effectiveness and safety of Vtama cream, 1%, in adult and pediatric patients with moderate-to-severe AD starting at age two.

The ADORING 3 study, which extended over 48 weeks, included eligible participants from the ADORING 1 and 2 trials, alongside a four-week maximal usage pharmacokinetics study. It also included Vtama cream-naive patients aged between two and 17 years with mild, moderate, or severe AD, who did not qualify for ADORING 1 and 2.

Data presented at the Annual Fall Clinical Dermatology Conference revealed that 51.9% of patients either entered the study with or achieved complete disease clearance at least once during the 48-week period. Additionally, 81.6% of participants either entered the study with or achieved clear or almost clear skin at least once.

For patients who entered ADORING 3 with complete disease clearance or achieved it for the first time and then stopped using Vtama, the average duration of the first treatment-free interval was 79.8 consecutive days. Those whose disease returned to mild or more severe states after stopping treatment were able to achieve complete clearance again upon re-treatment.

Importantly, there was no evidence of diminished response in patients who received either continuous or intermittent Vtama treatment. The therapy was well tolerated among participants.

The US Food and Drug Administration has already accepted Dermavant’s supplemental new drug application for Vtama in AD, with a decision expected in the fourth quarter of this year.

Robert Bissonnette, CEO of Innovaderm Research, a dermatology clinical research organization, commented on the recent data: “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.”