Watch for Dr James Del Rosso’s overview of VTAMA (tapinarof), 1% cream for atopic dermatitis, including his insights on clinical trial data, safety and systemic exposure, its potential remittive effect, and more.

The US FDA has approved VTAMA (tapinarof) cream, 1% for the treatment of atopic dermatitis (AD) in adults and children aged 2 years and older. This marks the second FDA-approved indication for VTAMA, an aryl hydrocarbon receptor agonist, following its initial approval in May 2022 for the treatment of plaque psoriasis in adults.

Clinical trial insights

The approval of VTAMA for atopic dermatitis is supported by robust data from the ADORING 1 and ADORING 2 pivotal studies as well as the long-term extension (LTE) study, ADORING 3.

• Primary endpoint: At Week 8, a significantly higher percentage of patients achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement from baseline:
  • ADORING 1: 45.4% (VTAMA) vs 13.9% (vehicle)
  • ADORING 2: 46.4% (VTAMA) vs 18.0% (vehicle)
  • Both results were statistically significant (P <0.0001)
• Secondary endpoints:
  • Improvement of at least 75% in Eczema Area and Severity Index at Week 8
  • ≥4-point improvement in the Peak Pruritus Numerical Rating Scale in patients aged 12 years and older

ADORING 3 (48-week long-term study):

• Patients achieving complete disease clearance (vIGA-AD=0) experienced a mean treatment-free interval of ~80 days
• Retreatment with VTAMA was effective in regaining disease control when symptoms recurred
• The safety profile over 48 weeks remained consistent with that observed in the 8-week pivotal studies

Safety profile

VTAMA cream demonstrated a favorable safety profile across all studies, including long-term use, and was well-tolerated on sensitive skin areas. The most common adverse reactions (≥1%) reported were upper respiratory tract infections, folliculitis, lower respiratory tract infections, headache, asthma, vomiting, ear infections, abdominal pain, and extremity pain.  

Expanding therapeutic options

The approval of VTAMA cream, 1%, adds to the growing list of treatment options for atopic dermatitis, offering a nonsteroidal topical alternative for patients. With its demonstrated efficacy and safety profile, VTAMA provides dermatologists with an additional choice for managing this chronic condition.