Tapinarof cream 1% rapidly improves itch in adults, children with atopic dermatitis
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Key takeaways:
- In ADORING 1, 61.1% of tapinarof-treated patients achieved itch responses vs. 34% of vehicle (P < .0001).
- In ADORING 2, 57.4% of the tapinarof group achieved the same vs. 33% of vehicle (P < .0001).
ANAHEIM, Calif. — Tapinarof cream was well tolerated and significantly improved itch in adults and children aged as young as 2 years with atopic dermatitis, according to a poster presentation here.
“Tapinarof is a non-steroidal, topical aryl hydrocarbon receptor agonist, approved by the [FDA] for the treatment of plaque psoriasis in adults, and under investigation for the treatment of [AD] in adults and children down to 2 years of age, and plaque psoriasis in children down to 2 years of age,” Jonathan I. Silverberg, MD, of The George Washington University School of Medicine and Health Sciences, and colleagues wrote in their poster presentation at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
In two pivotal phase 3, randomized, double-blind, vehicle-controlled trials, ADORING 1 (n = 407) and ADORING 2 (n = 406), researchers evaluated the efficacy and safety of tapinarof cream 1% in adults and children aged 2 years and older with AD.
In their presentation, Silverberg and colleagues reported the itch outcomes of these trials, as assessed on the Peak Pruritus-Numeric Rating Scale (PP-NRS), a patient-reported scale that assesses itch in the last 24-hours on a scale of 0, indicating no itch, to 11, indicating the “worst imaginable” itch.
In both ADORING 1 and 2, patients applied either tapinarof cream 1% (n = 270 and 271, respectively) or vehicle (n = 137 and 135, respectively) once daily for 8 weeks.
Among patients aged 12 years and older, a higher proportion of tapinarof-treated patients achieved a PP-NRS response compared with vehicle in ADORING 1 (55.8% vs. 34.2%; P = .0366) and ADORING 2 (52.8% vs. 24.1%; P = .0015) by week 8.
Among patients aged younger than 12 years, 60.7% of tapinarof-treated patients achieved a PP-NRS response vs. 28% treated with vehicle in ADORING 1 (P = .0001). Similarly in ADORING 2, a higher proportion of tapinarof-treated patients achieved this endpoint compared with vehicle (60% vs. 40.8%; P = .0414).
Overall, more PP-NRS responses occurred in the tapinarof groups vs. the vehicle groups in ADORING 1 (61.1% vs. 34%; P < .0001) and ADORING 2 (57.4% vs 33%; P < .0001).
Treatment adverse events were mostly mild or moderate with the most common being headache, folliculitis and nasopharyngitis. A lower proportion of tapinarof-treated patients discontinued due to adverse events compared with vehicle in ADORING 1 (1.9% vs. 3.6%) and ADORING 2 (1.5% vs. 3%).
“Tapinarof cream 1% [once daily] demonstrated statistically significant and clinically meaningful pruritus improvements versus vehicle for adults and children down to 2 years of age with AD,” the authors wrote.