Dermavant Sciences has shared positive long-term results for its plaque psoriasis-approved Vtama (tapinarof) cream in adults and children as young as two years old with atopic dermatitis (AD).

Commonly referred to as eczema, AD is one of the most common inflammatory skin diseases, affecting over 26 million people in the US and up to 10% of adults and 20% of children worldwide.

Dermavant previously reported positive results from the identically-designed phase 3 ADORING 1 and ADORING 2 trials, which evaluated the efficacy and safety of Vtama cream, 1% in adult and paediatric AD patients as young as two years with moderate-to-severe disease at baseline.

The ADORING 3 48-week long-term extension study enrolled eligible patients from ADORING 1 and 2, as well as a four-week maximal usage pharmacokinetics study, and Vtama cream-naive patients aged two to 17 years with either mild, moderate or severe AD who did not meet inclusion in ADORING 1 and 2.

Final data presented at the Annual Fall Clinical Dermatology Conference showed that 51.9% of patients entered with or achieved complete disease clearance at least once during the 48-week study, while 81.6% entered with or achieved clear or almost clear skin at least once.

After entering ADORING 3 with or first achieving complete disease clearance and discontinuing Vtama, the average duration of the first treatment-free interval was 79.8 consecutive days, and patients whose disease returned to mild or above off-treatment were able to gain complete clearance when re-treated.

There was also no evidence of loss of response in patients receiving either continuous or intermittent Vtama treatment, and the therapy was shown to be well tolerated.

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