For Atopic Dermatitis For Plaque Psoriasis
A man driving a car with a female passenger A man driving a car with a female passenger
Not actual patients/caregiver.

Results from the
open-label long-term extension study

VTAMA cream provided skin clearance and disease control of atopic dermatitis for patients down to 2 years of age.5

Not actual patients/caregiver.
A mom and son reading together
Not actual patients/caregiver.

The majority of patients achieved complete disease clearance on VTAMA cream

~52% (n=378/728) of patients with atopic dermatitis either entered with or achieved complete disease clearance (vIGA-AD=0) at least once in the 48-week, open-label, long-term extension (LTE) study.5

View Study Design

~80 Consecutive Treatment-Free Days

For patients with atopic dermatitis who entered with or achieved complete disease clearance and discontinued VTAMA cream (n=378), the average duration of the first treatment-free interval was
~80 consecutive days‡5

*Including patients who entered with vIGA-AD=0 (n=58) or vIGA-AD=1 (n=189), and vIGA-AD≥2 who achieved 0 or 1 (n=347).5

†Including patients who entered with vIGA-AD=0 (n=58) and patients entering with vIGA-AD≥1 who achieved vIGA-AD=0 at least once during the open-label LTE (n=320).5

‡Maintenance of clear or almost clear skin (vIGA-AD=0 or 1) off treatment, after first achieving complete disease clearance (vIGA-AD=0) and discontinuing treatment.

A child playing with her teddy bear
Not an actual patient.

Safe and well tolerated,
with long-term use

  • No new safety signals and there were low rates of study discontinuations due to treatment-emergent adverse events5
  • Long-term application of VTAMA cream demonstrated favorable local tolerability, even on sensitive skin areas including the face and neck5

Treatment-emergent Adverse Events of Special Interest (AESI) From the Open-label Long-term Extension Study2,5,8

AESI
Overall
N=728, n (%)
Contact dermatitis
11 (1.5)
Follicular event*
102 (14.0)
Headache
27 (3.7)
  • The most frequent TEAEs included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%); trial discontinuations due to TEAEs were low (2.6%)5
  • AESI of follicular events, contact dermatitis, and headache were mostly mild or moderate and associated with low discontinuation rates (1.0%, 0.4%, and 0%, respectively)5

TEAE, treatment-emergent adverse event.

*Includes folliculitis, follicular eczema, keratosis pilaris, milia, and application site folliculitis.

×

ADORING 3 Study Design

Study design of ADORING 3
Study design of ADORING 3
Off treatment5

Patients who entered the open-label LTE study with or achieved vIGA-AD=0 during the LTE study had VTAMA cream treatment temporarily discontinued

On treatment5

Patients who entered the open-label LTE study with vIGA-AD≥1 or with disease worsening (vIGA-AD≥2) during the LTE study were treated with VTAMA cream until vIGA-AD=0 was achieved (or Week 48)

Safety and Tolerability5
  • Treatment-emergent adverse events (TEAEs)
  • Adverse events of special interest (AESIs)
  • Local tolerability as assessed by investigator and patient (or caregiver)
Efficacy5
  • Achievement of vIGA-AD=0
  • Achievement of vIGA-AD=0 or 1
  • Treatment-free interval: mean duration of maintenance of clear or almost clear skin off treatment, after first achieving complete disease clearance and discontinuing treatment

AE, adverse event; LTE, long-term extension; MUPK, maximal usage pharmacokinetics; PP-NRS, Peak Pruritus-Numeric Rating Scale; QD, once-daily; vIGA-AD, Validated Investigator Global Assessment for Atopic Dermatitis. vIGA-AD is a trademark of Eli Lilly and Co.

*Pediatric patients aged 2–17 years with mild AD (vIGA-AD=2), or moderate or severe AD, that did not meet inclusion criteria for ADORING 1 and ADORING 2.

Safe and well tolerated

For patients down to 2 years of age1,2
Once-daily dosing

See more info on VTAMA cream dosing1
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.

 Back to top