New data from Dermavant showed high levels of efficacy and statistical significance for the topical cream, which is expected to have an sNDA on file with the US FDA in early 2024.
Tapinarof cream 1% (VTAMA, Dermavant) led to statistically significant improvements among adults and children with moderate-to-severe atopic dermatitis (AD).
Dermavant announced positive topline results1 this morning from its ADORING 1 study, a phase 3, double-blind, randomized, and vehicle-controlled study evaluating the safety and efficacy of the drug. The study is the second of the ADORING trials–the first of which, ADORING 2, yielded positive results that were announced in March. Dermavant said these results are consistent with today’s results and indicate that tapinarof cream 1%, if approved by the US Food and Drug Administration (FDA), may become a safe and effective steroid-free treatment option available for individuals with AD.
Study participants included 407 adults and children ages 2 years and older with moderate-to-severe atopic dermatitis. Participants were instructed to use either tapinarof cream 1% or a vehicle on a daily basis for an 8-week period.
Throughout the study, researchers used the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Rating Scale (PP-NRS) to evaluate participants’ disease improvement.
By week 8, 45.4% of participants being treated with tapinarof cream 1% received a clear or almost clear vIGA-AD score and experienced at least a 2-point improvement from baseline, compared to only 13.9% of participants being treated with the vehicle.
Furthermore, 55.8% of participants being treated with tapinarof cream 1% achieved EASI75, while 22.9% of participants being treated with the vehicle achieved the same endpoint. Additionally, 61.1% of participants being treated with tapinarof cream 1% achieved an equal to or greater than 4-point reduction in PP-NRS by week 8.
Researchers found that tapinarof cream 1% was well-tolerated in participants, reporting no safety or tolerability signals in the study population. Any adverse events were mild to moderate in nature, occurring in 1.9% of patients being treated with tapinarof cream 1% and in 3.6% of patients being treated with the vehicle.
The study also yielded a low discontinuation rate, with 91% of ADORING 1 and ADORING 2 subjects electing to participate in ADORING 3, an open-label, long-term extension study. The study will seek to further evaluate the safety and effectiveness of tapinarof cream 1% in patients with atopic dermatitis.
Adelaide A. Hebert, MD, professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann, spoke with Dermatology Times® to discuss the topline results.
“What is really exciting is that we really saw amazing responsiveness to this medicine both in reduction of the atopic dermatitis, the itching, and improvement in quality of life,” Hebert said. “It was quick in onset, it was comprehensive, it was very well-tolerated. So this is really a breakthrough for us with regard to topical therapy in managing a chronic, relapsing disorder.”
Hebert said one of the most exciting aspects of tapinarof, when comparing it to other topical AD treatments available to patients and dermatologists, is that it is steroid-free.
"It can be used on an ongoing basis without the concerns of thinning the skin, or causing striae: stretch marks,” she said. “We know that it works very effectively. It has a rapid onset of action, and the patients get clear, and they stay clear.”
While researchers have previously suspected the drug has a remittive effect, Hebert said this study is the first to demonstrate this type of effect in the drug. In also addressing the efficacy of tapinarof in young, pediatric populations, Hebert said this drug has the potential to deliver positive outcomes in patients of all age groups with AD.
"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'thave 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...Here is an opportunity for an effective, safe, hopefully readily available medication with very good outcomes in terms of patient success in controlling atopic dermatitis.”
Tapinarof cream 1% is currently FDA-approved to treat plaque psoriasis in adults and is the number 1 prescribed branded topical treatment for the condition as of July 2022. Dermavant said it expects to file a Supplemental New Drug Application (sNDA) with the FDA for the drug in early 2024.