Tapinarof shows significant safety, efficacy in atopic dermatitis
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Key takeaways:
- Patients with atopic dermatitis showed significant improvement with topical tapinarof cream treatment.
- Data from the ADORING 1 and ADORING 2 trials have been submitted to the FDA for the treatment of AD.
Topical tapinarof cream showed significant improvement of moderate to severe atopic dermatitis while being well tolerated by adults and children down to age 2 years, according to two phase 3 clinical trials.
“These are essentially the flagship results for the efficacy and pivotal studies of tapinarof in both adults and children,” Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University and the study’s main author, told Healio. “These will be the crucial data that will support the FDA approval and approval in other regions in children and adults with atopic dermatitis.”
The double-blind, randomized, vehicle-controlled, phase 3 ADORING 1 and ADORING 2 trials compared the safety and efficacy of once-daily tapinarof cream 1% (Vtama, Dermavant) with vehicle cream in more than 800 adult and pediatric patients who had a moderate to severe validated IGA score of 3 or 4.
At week 8, 45.4% and 46.4% of patients in the tapinarof treatment arms achieved a validated IGA response of clear or almost clear with a 2-grade or better improvement from baseline compared with 13.9% and 18% of those treated with placebo.
Additionally, EASI 75 response was achieved by 55.8% and 59.1% of the tapinarof treatment groups compared with 22.9% and 21.2% of the placebo groups, respectively.
Peak Pruritus Numerical Rating Scale scores were also significantly improved in 60.7% and 60% of patients aged younger than 12 years treated with tapinarof compared with 28% and 40.8% of those treated with vehicle, as well as overall with 61.1% and 57.4% of those in the tapinarof arms vs. 34% and 33% of the respective vehicle arms.
“The simple take home message is this drug works and it works well, and it’s very well tolerated,” Silverberg said. “We see, across all endpoints, demonstration of clear efficacy and really that it’s working on the totality of disease and even in some really tough cases and severe scenarios.”
Treatment-emergent adverse events occurred in less than 5% of any treatment arm with folliculitis, headache and nasopharyngitis being the most common.
Contact dermatitis events occurred in 1.5% and 1.1% of the treatment groups and 2.2% and 1.5% of those in the vehicle groups. Follicular events occurred in 10% and 8.9% of the treatment arms compared with 0.7% and 1.5% of the vehicle group, and headache was reported by 7% and 1.5% of the treatment arms vs. 2.2% and 0% of vehicle arms, respectively.
Tapinarof cream 1% is already FDA approved for the treatment of plaque psoriasis. A supplemental new drug application including atopic dermatitis on the drug’s indications was accepted for review by the FDA in April.
“These are the data that will be submitted to the FDA and we hope to be able to use this medication very soon in a dermatology office near you,” Silverberg said.
Reference:
- Dermavant announces publication of ADORING 1 and ADORING 2 pivotal phase 3 trials of Vtama (tapinarof) cream, 1% for adults and children 2 years of age and older with atopic dermatitis in JAAD. https://dermavant.com/dermavant-announces-publication-of-adoring-1-adoring-2-pivotal-phase-3-trials-of-vtama-tapinarof-cream-1-for-adults-and-children-2-years-of-age-and-older-with-atopic-dermatitis-in-jaad/. Published May 21, 2024. Accessed May 21, 2024.
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