TUESDAY, May 28, 2024 -- For pediatric and adult patients with atopic dermatitis (AD), tapinarof is efficacious and shows favorable safety and tolerability, according to a study published online May 20 in the Journal of the American Academy of Dermatology.

Jonathan I. Silverberg, M.D., Ph.D., M.P.H., from the George Washington University School of Medicine and Health Sciences in Washington, D.C., and colleagues examined tapinarof efficacy and safety in adults and children aged as young as 2 years with AD. Two eight-week phase 3 trials were conducted involving 813 patients who were randomly assigned to tapinarof or vehicle.

The researchers found that both trials met the primary efficacy end point of the Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and ≥2-grade improvement from baseline at week 8: 45.4 versus 13.9 percent and 46.4 versus 18.0 percent for tapinarof versus placebo. At week 8, significantly superior ≥75 percent improvement in the Eczema Area and Severity Index score from baseline responses was seen with tapinarof versus vehicle: 55.8 versus 22.9 percent and 59.1 versus 21.2 percent. Tapinarof versus vehicle was associated with significant rapid improvements in patient-reported pruritus. Folliculitis, headache, and nasopharyngitis were common adverse events (≥5 percent) and were mostly mild or moderate; lower discontinuation due to adverse events was seen in the tapinarof versus vehicle groups.

"Tapinarof potentially fills a gap in the treatment armamentarium for a highly effective, nonsteroidal topical that can be used down to 2 years of age," the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Dermavant, which manufactures tapinarof and funded the study.