Tapinarof cream shows efficacy in atopic dermatitis

Tapinarof cream was associated with significant improvement as assessed by Investigator Global Assessment in a cohort of adults and adolescents with atopic dermatitis, according to a study.

“Topical treatment directed at skin inflammation is a key part of disease management to provide symptomatic relief from the core symptoms of AD, such as pruritus,” Amy S. Paller, MD, of Northwestern University Feinberg School of Medicine, and colleagues wrote. “Although there are several topical options available for the treatment of AD, there remains a need for efficacious topical therapies that can be used without restrictions on body surface area (BSA) or treatment duration.”

In the phase 2b, double-blind, vehicle-controlled study, researchers randomly assigned 247 patients to tapinarof (Dermavant), a topical therapeutic aryl hydrocarbon receptor modulating agent, or placebo.

Eligible participants included adolescents and adults with AD from 53 sites in the U.S., Canada and Japan.

The population included 40 patients treated with twice-daily 1% tapinarof cream, 41 patients treated with daily 1% tapinarof cream, 43 patients treated with twice-daily 0.5% tapinarof cream, 41 patients treated with daily 0.5% tapinarof cream, 42 patients treated twice daily with vehicle and 40 patients treated daily with vehicle. One hundred ninety-one patients completed the study.

At 12 weeks, the researchers assessed for IGA, which was the primary endpoint, Eczema Area and Severity Index, BSA affected, pruritus numeric rating scale scores, patient impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores.

Results from the 12-week analysis showed that 53% of patients treated twice daily with tapinarof 1% reached IGA score of clear or almost clear and a two-grade or greater improvement in IGA score from baseline (P = .008) compared with 46% of those treated with 1% once daily, 37% treated with 0.5% twice daily and 34% for those treated with 0.5% once daily, while 24% of those treated twice daily with vehicle and 28% of those treated once daily with vehicle reached this endpoint.

Similarly, patients treated with 1% tapinarof once or twice daily demonstrated at least 75% or 90% improvement from baseline in EASI score compared with vehicle. However, while both 0.5% regimens bested vehicle in this endpoint, the improvement did not reach statistical significance. That said, all tapinarof arms showed a significant improvement in EASI score.

All tapinarof regimens except 0.5% twice daily significantly improved BSA outcomes, according to the findings.

All active treatment groups showed improvement as assessed by POEM, while patients reported that both AD and pruritis symptoms were “very/moderately” improved by intervention with tapinarof.

The safety profile showed that tapinarof was associated primarily with mild or moderate events, with “no apparent patterns” emerging, according to the researchers.

“The results also demonstrate that tapinarof cream had beneficial effects on secondary efficacy and [patient-reported outcomes] in adolescents and adults with AD,” the researchers said.