VTAMA cream is now approved for patients with atopic dermatitis down to 2 years of age1

VTAMA cream is now approved for patients with atopic dermatitis down to 2 years of age1

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In patients with atopic dermatitis down to
2 years of age, VTAMA cream demonstrated:

Powerful skin clearance

In the 8-week pivotal studies:

  • Up to 46% of patients achieved clear or almost clear skin compared to 18% on vehicle*2

In the 48-week open-label, long-term extension (LTE) study:

  • The majority of patients (~52%) entered with or achieved complete disease clearance (vIGA-AD score of 0) at least once3
  • Patients had ~80 consecutive treatment-free days on average after achieving complete disease clearance†3
little boy
Not an actual patient.
Not an actual patient.
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Rapid itch relief

Statistically significant itch relief as early as Day 2 in the pivotal studies2,4,5

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Favorable safety and tolerability across 56-weeks‡§

A favorable and consistent safety profile in both the 8-week pivotal studies and the 48-week LTE study1; and was well-tolerated, even on affected sensitive skin areas6

The most common adverse reactions (incidence ≥1%) in patients with atopic dermatitis treated with VTAMA cream were upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.

vIGA-AD™, Validated Investigator Global Assessment for Atopic Dermatitis. Trademark of Eli Lilly and Co.
*
vIGA-AD™ treatment success, defined as vIGA-AD™ 0 or 1 and ≥2-grade improvement from baseline, for VTAMA cream vs vehicle at Week 8 in ADORING 1 (45% vs 14%; P<0.0001) and ADORING 2 (46% vs 18%; P<0.0001).
Average duration of first treatment-free interval.
Not for oral, ophthalmic, or intravaginal use.
§
Patient/caregiver-reported tolerability scores (0-4) assessed the presence and degree of burning/stinging and of itching at the application sites, from (0) none to (1) slight, (2) mild, (3) moderate, or (4) strong/severe.

Visible results shown in a wide range of patients

  • Primary Endpoint Success**2
  • Age: 3
  • Gender: Male
  • Race: Asian
  • Ankle / Fitzpatrick Skin Type V
  • Primary Endpoint Success**2
  • Age: 9
  • Gender: Female
  • Race: White
  • Antecubital Fossa / Fitzpatrick Skin Type IV
  • Primary Endpoint Failure††2
  • Age: 54
  • Gender: Male
  • Race: White
  • Hand / Fitzpatrick Skin Type II
Baseline
Baseline
vIGA-AD™=3
EASI=18.4
IDQOL=14
POEM=10
PP-NRS=7
Week 2
Week 2
vIGA-AD™=2
EASI=7.5
IDQOL=9
POEM=0
PP-NRS=2.9
Week 4
Week 4
vIGA-AD™=2
EASI=4.0
IDQOL=5
POEM=1
PP-NRS=0.9
Week 8
Week 8
vIGA-AD™=1
EASI=0.6
IDQOL=7
POEM=0
PP-NRS=0.1
Baseline
Baseline
vIGA-AD™=3
EASI=26.0
CDLQI=5
POEM=26
PP-NRS=10
Week 2
Week 2
vIGA-AD™=2 EASI=8.8
CDLQI=2
POEM=3
PP-NRS=6.9
Week 4
Week 4
vIGA-AD™=1
EASI=2.7
CDLQI=0
POEM=1
PP-NRS=3.6
Week 8
Week 8
vIGA-AD™=1
EASI=1.1
CDLQI=1
POEM=1
PP-NRS=1
Baseline
Baseline
vIGA-AD™=4
EASI=11.6
DLQI=15
POEM=28
PP-NRS=5
Week 2
Week 2
vIGA-AD™=2
EASI=3.6
DLQI=7
POEM=16
PP-NRS=5.3
Week 4
Week 4
vIGA-AD™=2
EASI=2.4
DLQI=3
POEM=14
PP-NRS=2
Week 8
Week 8
vIGA-AD™=2
EASI=3.0
DLQI=1
POEM=13
PP-NRS=1.4
**Primary Endpoint Success, defined as vIGA-AD score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline at Week 8. ††Primary endpoint failure defined as failure to achieve vIGA-AD score of 0 or 1 (clear or almost clear) and ≥2-grade improvement from baseline at Week 8.2 Validated Investigator Global Assessment AD (vIGA-AD) – measure of AD severity with scores ranging from 0 (clear) to 4 (severe). Eczema Area and Severity Index (EASI) – measure of disease severity that incorporates body surface and lesion intensity into a composite score from 0 to 72, with higher scores indicating more severe disease. Infants' Dermatitis Quality of Life Index (IDQOL) – 10-item questionnaire to measure impact on quality of life (QoL) in patients 2 to 3 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Children’s Dermatology Life Quality Index (CDLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients 4 to 15 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Dermatology Life Quality Index (DLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients ≥16 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Patient Oriented Eczema Measure (POEM) - 7-item questionnaire to measure eczema severity focusing on the disease as experienced by the patient. Scores range from 0 to 28, with higher score indicating more severe disease. Peak Pruritus-Numeric Rating Scale (PP-NRS) - patients are asked to rate their worst itch in the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). Baseline value represents the PP-NRS score reported on the baseline visit day. Week 2, 4, and 8 values represent the weekly average of the PP-NRS scores for that corresponding week.
**Primary Endpoint Success, defined as vIGA-AD score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline at Week 8. ††Primary endpoint failure defined as failure to achieve vIGA-AD score of 0 or 1 (clear or almost clear) and ≥2-grade improvement from baseline at Week 8.2 Validated Investigator Global Assessment AD (vIGA-AD) – measure of AD severity with scores ranging from 0 (clear) to 4 (severe). Eczema Area and Severity Index (EASI) – measure of disease severity that incorporates body surface and lesion intensity into a composite score from 0 to 72, with higher scores indicating more severe disease. Infants' Dermatitis Quality of Life Index (IDQOL) – 10-item questionnaire to measure impact on quality of life (QoL) in patients 2 to 3 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Children’s Dermatology Life Quality Index (CDLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients 4 to 15 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Dermatology Life Quality Index (DLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients ≥16 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Patient Oriented Eczema Measure (POEM) - 7-item questionnaire to measure eczema severity focusing on the disease as experienced by the patient. Scores range from 0 to 28, with higher score indicating more severe disease. Peak Pruritus-Numeric Rating Scale (PP-NRS) - patients are asked to rate their worst itch in the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). Baseline value represents the PP-NRS score reported on the baseline visit day. Week 2, 4, and 8 values represent the weekly average of the PP-NRS scores for that corresponding week.
**Primary Endpoint Success, defined as vIGA-AD score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline at Week 8. ††Primary endpoint failure defined as failure to achieve vIGA-AD score of 0 or 1 (clear or almost clear) and ≥2-grade improvement from baseline at Week 8.2 Validated Investigator Global Assessment AD (vIGA-AD) – measure of AD severity with scores ranging from 0 (clear) to 4 (severe). Eczema Area and Severity Index (EASI) – measure of disease severity that incorporates body surface and lesion intensity into a composite score from 0 to 72, with higher scores indicating more severe disease. Infants' Dermatitis Quality of Life Index (IDQOL) – 10-item questionnaire to measure impact on quality of life (QoL) in patients 2 to 3 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Children’s Dermatology Life Quality Index (CDLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients 4 to 15 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Dermatology Life Quality Index (DLQI) - 10-item questionnaire to measure impact on quality of life (QoL) in patients ≥16 years of age. Scores range from 0 to 30, with higher scores indicating higher impairment on QoL. Patient Oriented Eczema Measure (POEM) - 7-item questionnaire to measure eczema severity focusing on the disease as experienced by the patient. Scores range from 0 to 28, with higher score indicating more severe disease. Peak Pruritus-Numeric Rating Scale (PP-NRS) - patients are asked to rate their worst itch in the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). Baseline value represents the PP-NRS score reported on the baseline visit day. Week 2, 4, and 8 values represent the weekly average of the PP-NRS scores for that corresponding week.

Commercially insured patients may pay as little as $0 and no more than $35‡‡

Get a patient started in 3 easy steps

1 1

Identify appropriate patients

VTAMA cream is a once-daily, steroid-free treatment that was studied in and approved for patients as young as 2 years of age with mild, moderate and severe atopic dermatitis1

2 2

Transmit requirements

  • ICD-10 code (eg, L30.9, L20.9, L20.89)
  • BSA %
  • Area(s) affected
  • Previous medications and time frames
  • Chart notes, if required
3 3

Give commercially insured patients the MyVTAMA™ card‡‡

The MyVTAMA card may be used at any participating pharmacy location in the United States. Over 6,000 US pharmacies have redeemed the MyVTAMA savings card§§

MyVTAMA Savings Card
‡‡Eligibility required. This offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program.
§§IQVIA National Prescription Audit (NPA) for the period 5/20/22 to 11/22/2024, reflecting estimates of real-world activity. All rights reserved.
IMPORTANT SAFETY INFORMATION

Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for:

Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: red raised bumps around the hair pores (folliculitis), pain or swelling in the nose and throat (nasopharyngitis), skin rash or irritation, including itching and redness, peeling, burning, or stinging (contact dermatitis), headache, itching (pruritus), and flu (influenza).

Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, red raised bumps around the hair pores (folliculitis), lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and stomach-area (abdominal) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References
1. VTAMA (tapinarof) cream, 1%. Prescribing Information. Dermavant; 2024. 2. Silverberg JI, Boguniewicz M, Rubenstein DS, et al. Tapinarof Cream Improved Itch In Two Phase 3 Trials Of Moderate To Severe Atopic Dermatitis. Ann Allergy Asthma Immunol. 2023;131:S90 (P282). 3. Bissonnette R, Stein Gold L, Kircik L, et al. Skin Clearance, Treatment Response Off-therapy, and Safety of Tapinarof Cream 1% Once Daily: Results from ADORING 3, a 48-week Phase 3 Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis. Poster presented at: Fall Clinical Dermatology Conference; October 24-27, 2024; Las Vegas, NV. 4. Simpson E, et al. Oral presented at: European Academy of Dermatology and Venereology; October 11-14, 2023. 5. Dermavant DOF [ADORING 1&2 Pooled Posthoc; Jan 2025]. 6. Stein Gold L, Del Rosso J, Ehst BD, et al. Tapinarof Cream 1% Once Daily was Well Tolerated for the Treatment of Adults and Children Down to 2 Years of Age with Moderate to Severe Atopic Dermatitis Across Two Pivotal Phase 3 Trials. Poster presented at American Academy of Dermatology Annual Meeting; March 8-11, 2024; San Diego, CA.