ADORING 3: Tapinarof Cream Maintains AD Clearance for 80 Days Post-Treatment

10/25/2024

Key Takeaways

  • VTAMA® (tapinarof) cream, 1% achieved complete skin clearance in over half of study participants, maintaining results for 80 days post-treatment.
  • Pediatric patients (comprising 83% of the study population) showed favorable outcomes with acceptable safety.
  • ADORING 3 suggests tapinarof cream is a safe, nonsteroidal option for long-term management of AD, according to Dermavant.

Results from the ADORING 3 long-term extension study showed that VTAMA® (tapinarof) cream, 1% achieved complete skin clearance in atopic dermatitis (AD) patients as young as two years old, maintaining clear or nearly clear skin for an average of 80 days post-treatment.

The 48-week study, presented at the Fall Clinical Dermatology Conference, evaluated VTAMA cream’s efficacy and safety for 728 participants, 83% of whom were pediatric patients. The study included patients from earlier ADORING 1 and 2 trials, as well as new enrollees. A total of 51.9% of patients reached a vIGA-AD score of zero at least once, indicating complete disease clearance, while 81.6% achieved nearly clear or completely clear skin (vIGA-AD = 0 or 1) at some point during the study.

Treatment-emergent adverse events included mild or moderate folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory infections (6.9%). Few adverse events led to study discontinuation (2.6%).

“In the ADORING long-term extension study, VTAMA 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” said Robert Bissonnette, MD, FRCPC, Chief Executive Officer at Innovaderm Research, in a press release. “Moreover, upon reaching complete disease clearance and ceasing treatment, patients stayed clear or almost clear for an average period of approximately 80 consecutive days. These results, combined with those from the ADORING 1 and ADORING 2 pivotal studies, demonstrate VTAMA 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.”

Dermavant has submitted a Supplemental New Drug Application (sNDA) for VTAMA in treating AD, with an FDA action date expected in Q4 2024.

Source: Dermavant press release. October 25, 2024. 

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