FAQ - Vtama® (tapinarof) Cream

What is Vtama?

Vtama (tapinarof) cream (1%) is an aryl hydrocarbon receptor (AHR) agonist approved by the FDA for the topical treatment of atopic dermatitis in adults and children 2 years of age and older.

Together, you and your healthcare provider can determine if Vtama is an appropriate treatment option.

How does Vtama work?

Vtama is not a topical steroid. It works by specifically binding to and activating the aryl hydrocarbon receptor (AHR) to downregulate inflammatory pathways and oxidative stress, and increase expression of proteins involved in skin barrier function.

How do you use Vtama?

Vtama is applied as a thin film directly to the affected areas of skin once daily.¹

How effective is Vtama for atopic dermatitis?

In the two ADORING Phase 3 clinical trials for Vtama, after 8 weeks of continuous use²:

Primary clinical trial endpoint – Validated Investigator Global Assessment (vIGA)
- A tool used to provide a clinical trial investigator rating of overall disease severity at a particular time point.
- 45.4% and 46.4% of patients had a vIGA score of clear to almost clear (vIGA 0 or 1) versus 13.9% and 18% using the vehicle only (cream base of Vtama without the medication).
Key secondary clinical trial endpoints:
- Eczema Area and Severity Index (EASI)-75
  - An investigator tool used to measure the extent (area) and severity of atopic dermatitis. EASI-75 is a 75% improvement in this score from the start of the trial.
  - 55.8% and 59.1% of patients achieved an EASI-75 versus 22.9% and 21.2% using vehicle only.
- Reduction in itch severity (PP-NRS); at least a 4-point decrease on an 11-point (0-10) numeric rating scale).
  - Patients 12+ years old: 55.8% and 52.8% had a statistically significant improvement in itch compared to 34.2% and 24.1% using vehicle only.
  - Patients less than 12 years old: 60.7% and 60.0% had a statistically significant improvement in itch compared to 28.0% and 40.8% using vehicle only.
Clinical trial long-term extension data (48 weeks) has not yet been published, however interim results suggest continued efficacy and safety of Vtama.³

What are the side effects of Vtama?

The most common adverse reactions from clinical trials (incidence greater than/equal to 1%) are upper or lower respiratory tract infections, folliculitis (inflamed hair follicles), headache, asthma, vomiting, ear infections, extremity or stomach pain. Most adverse reactions were mild or moderate in severity.

How is Vtama different from topical corticosteroids (TCS)?

Topical corticosteroids work non-specifically to reduce inflammation in the skin by preventing cells from producing inflammation-causing chemicals that are released in response to a variety of different triggers.

Vtama works in a more targeted manner to activate the aryl hydrocarbon receptor (AHR) to downregulate inflammatory pathways and improve barrier function. Because Vtama is not a topical corticosteroid, it is able to be used over a longer period of time,^2,3 and on body areas that are more delicate or have thinner skin, such as the face, genitals, or skin folds, where topical corticosteroid use is not preferred.

How long do I have to take Vtama?

Atopic dermatitis is a chronic skin disease that can affect everyone differently. The length of therapy with Vtama should be discussed with your healthcare provider.

Can children use Vtama?

Vtama is FDA-approved for children ages 2 years and older.

How much does Vtama cost?

Cost depends on your health insurance coverage for prescriptions. Dermavant, an Organon company, the company that makes Vtama, has a program to help with your copay costs if needed. You can apply at MyVTAMA or call 347.532.5250 (9 a.m. – 7 p.m. ET).

How do I know if Vtama is right for me?

It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if Vtama is an appropriate treatment option.

How can I get Vtama?

Vtama is available by prescription only. Talk to your healthcare provider and visit Vtama.com to learn more.

Can I use Vtama with other prescription atopic dermatitis therapies?

Talk to your healthcare provider about using Vtama with other prescription and over-the-counter therapies for atopic dermatitis. Vtama has not been studied in combination with other topical, oral or injectible atopic dermatitis medications.

Be sure your doctor knows all medications you are using for your atopic dermatitis as well as other medical conditions.

References:

¹Prescribing information. https://www.vtama.com/eczema/

²Silverberg JI, Eichenfield LF, Hebert AA et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024 Sep;91(3):457-465

3 Dermavant Presents ADORING 3 LTE Final Data on Complete Skin Clearance and Treatment-Free Interval for VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as Two Years Old with Atopic Dermatitis at the 44th Annual Fall Clinical Dermatology Conference. October 24, 2024. https://dermavant.com/dermavant-presents-adoring-3-lte-final-data-on-complete-skin-clearance-and-treatment-free-interval-for-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as-two-years-old-with-atopic-der/