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New Positive Topline Results of Tapinarof Cream for AD Down to 2 Years

Article

Dermavant’s ADORING 2 phase 3 trial met all primary and secondary endpoints.

Zoa-Arts/AdobeStock
Zoa-Arts/AdobeStock

Dermavant Sciences recently announced new positive topline results from its ADORING 2 (NCT05032859) phase 3 clinical trial evaluating the safety and efficacy of once daily (QD) tapinarof (Vtama) cream, 1% in adults and children down to 2 years of age with atopic dermatitis.1 Out of 406 patients, 46.4% receiving tapinarof cream achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response of clear (0) or almost clear (1) with an at least 2-grade improvement from baseline at week 8 compared to 18% on vehicle.

Pediatric and adult patients with atopic dermatitis were randomized at a 2:1 ratio to receive QD tapinarof or vehicle cream. Topline results from ADORING 2 include:

  • 46.4% of patients treated with tapinarof cream achieved the primary endpoint of a vIGA-AD of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at week 8 (P<0.0001)
  • 59.1% of patients treated with tapinarof cream achieved the key secondary endpoint of the proportion of patients with ≥75% improvement in EASI75 (P<0.0001)
  • 52.8% of patients ≥12 years old, with a baseline PP-NRS score ≥4, achieved a ≥4-point reduction in the PP-NRS at week 8 (P=0.0015)
  • Tapinarof cream data indicated no safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% tapinarof vs. 3.0% vehicle)
  • Adverse events of special interest included contact dermatitis (1.1% tapinarof vs. 1.5% vehicle) and follicular event (8.9% tapinarof vs. 1.5% vehicle)

Pending approval from the US Food and Drug Administration (FDA), Dermavant believes tapinarof cream could be a crucial “manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to both physicians, pharmacists, and patients, regardless of diagnosis.”1

Philip M. Brown, MD, JD, and chief medical officer of Dermavant noted that topline data from the identically designed ADORING 1 trial (NCT05014568) is expected in May 2023. Dermavant’s ADORING 3 (NCT05142774) clinical trial, a long term, open-label study is currently recruiting and is expected to conclude in September 2024.

Tapinarof cream was approved by the FDA in May 2022 for the treatment of plaque psoriasis in adult patients. The 2022 FDA approval made tapinarof the first non-steroidal topical novel product for psoriasis available in the United States in over 2 decades.

Reference

  1. Dermavant reports positive topline results from ADORING 2 atopic dermatitis phase 3 trial of Vtama (tapinarof) cream, 1% once daily in adults and children as young as 2 years old. Dermavant Sciences. Published March 15, 2023. Accessed March 15, 2023. https://www.dermavant.com/dermavant-reports-positive-topline-results-from-adoring-2-atopic-dermatitis-phase-3-trial-of-vtama-tapinarof-cream-1-once-daily-in-adults-and-children-as-young-as-2-years-old/
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