Dermavant has announced positive results from their ADORING 1 study evaluating the efficacy and safety of topical VTAMA® (tapinarof) cream, 1%.
This double-blind, randomized, Phase 3 study evaluated the safety and efficacy of tapinarof cream 1% in adults and pediatric patients aged two years and above with moderate-to-severe atopic dermatitis (AD). It is the second study of the ADORING trials. The first, ADORING 2, also yielded positive results.
ADORING 1 included 407 participants who were given tapinarof cream 1% or a vehicle to be applied daily for a period of eight weeks. Results were measured through the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Rating Scale (PP-NRS).
At week eight, the study revealed that 45.4% of the tapinarof cream 1%-treated participants had received a clear or almost clear vIGA-AD score. Furthermore, they experienced at least a two-point improvement from baseline compared to only 13.9% of those treated with the vehicle.
In addition, 55.8% of participants treated with tapinarof cream 1% achieved ≥75% improvement in EASI from baseline at week eight compared to 22.9% of vehicle-treated patients. In measuring PP-NRS, it was revealed that 61.1% of the participants who received tapinarof cream 1% achieved a ≥4-point reduction at week eight.
The study also revealed that tapinarof cream 1% was well-tolerated in patients, with no safety or tolerability signals in the study population. The adverse events reported were mostly mild to moderate and occurred in only 1.9% of those treated with tapinarof cream 1% and in 3.6% of those treated with vehicle.
Researchers have also stated that 91% of subjects from ADORING 1 and ADORING 2 have elected to enroll in the Phase 3 ADORING 3 open-label, long-term safety study, which will seek to further evaluate the safety and efficacy of tapinarof cream 1% in patients with AD.
Adelaide A. Hebert, MD, speaker at LiVDerm’s Masters of Pediatric Dermatology Symposium and professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, has stated,
"Having a medicine that’s safe and effective, and able to be used long-term in the young population, is exceedingly valuable. We want to have medications we can offer to patients and parents–they don't have to be afraid of using it, they'll absolutely see a rapid onset of action, they'll see a demonstrable improvement in their child's well-being, and we can honestly say that this is really an innovative therapy. There is not another therapy of this particular basis, on the market or in the planned market that I'm aware of.”
Dermavant has revealed that they expect to file a Supplemental New Drug Application with the U.S. Food and Drug Administration for the drug in early 2024.
- https://www.dermatologytimes.com/view/adoring-1-study-reveals-promising-results-for-tapinarof-in-atopic-dermatitis
- https://www.businesswire.com/news/home/20230516005549/en/Dermavant-Reports-Positive-Topline-Results-from-ADORING-1-the-Second-Atopic-Dermatitis-Phase-3-Trial-of-VTAMA%C2%AE-tapinarof-Cream-1-in-Adults-and-Children-as-Young-as-2-Years-Old
