Adelaide Hebert, MD: Positive Phase 3 Data on Tapinarof for Atopic Dermatitis Patients

In this HCPLive interview, Adelaide A. Hebert, MD, discussed the results of ADORING 1, the second of 2 double-blind, randomized, phase 3 studies examining the efficacy and safety of topical tapinarof cream, 1% for adults and children with moderate to severe atopic dermatitis.

Hebert is known for her work as professor and chief of pediatric dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann.

“I think one of the things that's really key is this was an 8 week, double blind study, and we enrolled patients from as young as 2 years of age all the way up to one 81-year-old patient, so a broad range of ages,” she explained.

She added that while the study was made up of 80 to 90% that had moderate atopic dermatitis, 11% had severe cases of atopic patients, with EASI scores ranging from 12 to 13, on average, with a BMI of 21 to 23.

“What we found was minimal absorption and no accumulation,” she said. “Very exciting features of this particular drug, which is an aryl hydrocarbon receptor agonist. A new class of medications and topical formulation, one of the newest drugs to be on the frontier for atopic dermatitis.”

Hebert pointed out that dermatologists really have not had a topical treatment since 2001 for the skin disorder. These positive results from ADORING 1 were found to be consistent with the positive results of ADORING 2 in March.

Overall, 45.4% of those receiving tapinarof cream were shown to have achieved a Validated Investigator Global Assessment for atopic dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% receiving vehicle, meeting the primary endpoint (P<0.0001).

“We had very few patients drop out,” Hebert said. “We had a discontinuation rate in those enrolled in the cohort that actually received tapinarof of only 1.9%.”

She also noted that the treatment achieved statistical significance for all of its secondary endpoints as well, including the proportion of patients with at least 75% improvement in Eczema Area and Severity Index (EASI75) from baseline by 8 weeks.

“I think what is really exciting here is we've developed a new medicine, we use it once daily, and we can use it over fairly extensive body surface areas with excellent outcome, even in the smallest patients,” she stated. “We really have been looking for a steroid free option for quite some time.”

To find out more about the new trial data, view the interview featured above.