Tapinarof cream is effective and well tolerated for both adolescent and adult patients with atopic dermatitis (AD), according to results published in the Journal of the American Academy of Dermatology.
The study included participants age 12 to 65 years with body surface area involvement ≥5% and ≤35% and Investigator Global Assessment ≥3 (moderate-severe) at baseline (n=247) (ClinicalTrials.gov Identifier: NCT02564055, GSK study 203121). Participants were randomly assigned 1:1:1:1:1:1 to tapinarof 1% twice daily, tapinarof 1% once daily, tapinarof 0.5% twice daily, tapinarof 0.5% once daily, vehicle twice daily, or vehicle once daily. The primary end point was Investigator Global Assessment score of clear or almost clear (0 or 1) and minimum 2-grade improvement at week 12. Secondary end points included ≥75% improvement in Eczema Area Severity Index and reduction of numeric rating scale itch from baseline.
At week 12, 53% of participants in the 1% twice-daily group achieved treatment success compared with 46% in the 1% once-daily group, 37% in the 0.5% twice-daily group, 34% in the 0.5% once-daily group, 24% in the vehicle twice-daily group, and 28% in the vehicle once-daily group. These results indicated that the rate of success for 1% twice daily was significantly higher than for vehicle twice daily.
The proportion of participants who achieved Eczema Area Severity Index 75 at week 12 was highest among the tapinarof groups (60% for 1% twice daily and 51% for 1% once daily), and higher with tapinarof overall than with vehicle (0.5% tapinarof groups: 51% twice daily and 39% once daily; vehicle: 26% twice daily and 25% once daily).
Treatment-emergent adverse events (TEAE) occurred in 56% (93/165) of participants randomly assigned to tapinarof compared with 41% (34/82) randomly assigned to vehicle. TEAEs were mild to moderate in intensity, and the most frequently reported TEAE was nasopharyngitis.
“A full understanding of the positioning of tapinarof in the treatment paradigm of AD cannot be made at this time; however, the current results indicate that tapinarof may provide a new addition to the armamentarium for both adults and adolescents with AD,” the researchers wrote.
Disclosure: This study was funded by GlaxoSmithKline (protocol 203121).
Peppers J, Paller AS, Maesa-Chubachi T, et al. A phase 2, randomized dose-finding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis [published online July 3, 2018]. J Am Acad Dermatol. doi:10.1016/ j.jaad.2018.06.047