Significantly clearer skin for up to 52 Weeks
At the end of the 12-week pivotal studies, 763 patients rolled over to PSOARING 3, an open-label, long-term extension (LTE) study.1
PSOARING 3:
Proven Safety and Sustained Efficacy
Following completion of the 12-week pivotal studies, 763 patients entered PSOARING 3, an open-label LTE study. The trial evaluated VTAMA in adults with plaque psoriasis over 40 weeks, including safety, durability of response, and the duration of treatment-free effect (time to PGA≥2 from PGA=0).1
At the end of the 12-week pivotal studies, 763 adult patients (92% of eligible patients) rolled over to the open-label LTE study1
Clinically Proven to Deliver
Consecutive Time Off Treatment
Following 12 weeks of treatment with VTAMA, 73 patients entered the LTE study with clear skin (PGA=0) and had VTAMA withdrawn. These patients were followed for up to 40 additional weeks with a median duration of disease control (PGA=0 or 1) of 114 consecutive days off therapy for the first treatment-free interval.1
Before and After Images
See the significant results from some adult patients using VTAMA in the LTE study. VTAMA helped adult patients with mild, moderate, and severe plaque psoriasis achieve clearer skin. Please note that the scores reflect a global assessment of the patient's plaque psoriasis, whereas the images are only representative of one lesion or body area. Individual results may vary.
Torso
Age: 41 Gender: Female Patient: 1015-001
Primary Endpoint Success2
Baseline
Physician Rated
PGA=4
PASI*=19.8
PASI*=19.8
Patient Rated†
DLQI=6
PP-NRS‡=10
PP-NRS‡=10
Week 12
Physician Rated
PGA=1
PASI*=3.8
PASI*=3.8
Patient Rated†
DLQI=0
PP-NRS‡=0
PP-NRS‡=0
Week 36 (Open-label LTE study week 24)
Off-treatment
Physician Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated†
DLQI=0
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 40 (Open-label LTE study week 28)
Off-treatment
Physician Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated†
DLQI=0
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 48 (Open-label LTE study week 36)
Off-treatment
Physician Rated
PGA=2
PASI*=5.4
PASI*=5.4
Patient Rated†
DLQI=2
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 52 (Open-label LTE study week 40)
On-treatment
Physician Rated
PGA=3
PASI*=5.4
PASI*=5.4
Patient Rated†
DLQI=3
PP-NRS‡=N/A
PP-NRS‡=N/A
Age: 41 Gender: Female Patient: 1015-001
Primary Endpoint Success9
Baseline
Physician Rated
PGA=4
PASI*=19.8
PASI*=19.8
Patient Rated†
DLQI=6
PP-NRS‡=10
PP-NRS‡=10
Week 12
Physician Rated
PGA=1
PASI*=3.8
PASI*=3.8
Patient Rated†
DLQI=0
PP-NRS‡=0
PP-NRS‡=0
Week 36 (Open-label LTE study week 24)
Off-treatment
Physician Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated†
DLQI=0
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 40 (Open-label LTE study week 28)
Off-treatment
Physician Rated
PGA=1
PASI*=1.2
PASI*=1.2
Patient Rated†
DLQI=0
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 48 (Open-label LTE study week 36)
Off-treatment
Physician Rated
PGA=2
PASI*=5.4
PASI*=5.4
Patient Rated†
DLQI=2
PP-NRS‡=N/A
PP-NRS‡=N/A
Week 52 (Open-label LTE study week 40)
On-treatment
Physician Rated
PGA=3
PASI*=5.4
PASI*=5.4
Patient Rated†
DLQI=3
PP-NRS‡=N/A
PP-NRS‡=N/A
DLQI, Dermatology Life Quality Index; N/A, not applicable; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PP-NRS, Peak Pruritus-Numeric Rating Scale.
*PASI was measured as a secondary endpoint.
†DLQI and PP-NRS are patient-reported outcomes.
‡PP-NRS, a patient self-reported item, is an 11-point scale ranging from "no itch" (0) to "worst itch possible" (10), designed to assess worst itch experienced in a 24-hour period.
Favorable and consistent safety profile seen in an open-label LTE study1
Treatment-emergent adverse events of special interest in the open-label LTE study3
- In a 40-week, open-label LTE study, VTAMA cream demonstrated a favorable safety profile1
- The rates of folliculitis and contact dermatitis were consistent with the pivotal studies1
References: 1. Organon DOF [MyVTAMA Pharmacy Count; Jan 2023].
2. VTAMA (tapinarof) cream, 1%. Prescribing Information. Organon; 2022.
3. Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of
tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad
Dermatol. 2022;87(4):800-806. 4. Stein Gold L, Kircik L, Lebwohl M, et al.
Tapinarof cream 1% once daily for plaque psoriasis: favorable local tolerability in two pivotal phase 3
trials. Poster presented at: Innovations in Dermatology Conference; March 16–20, 2021; virtual.
5. Lebwohl M, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for
plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. 6. Organon DOF.
CSR-DMVT-505-3001. A phase 3 efficacy and safety study of tapinarof for the treatment of plaque
psoriasis in adults. 2020. 7. Organon DOF. CSR-DMVT-505-3002. A phase 3 efficacy and
safety study of tapinarof for the treatment of plaque psoriasis in adults. 2020. 8.
Stein Gold L, Blauvelt A, Armstrong A, et al. Tapinarof cream 1% once daily for plaque psoriasis:
secondary efficacy outcomes from two pivotal phase 3 trials. Poster presented at: International
Federation of Psoriasis Associations; June 30–July 3, 2021; virtual. 9. Organon DOF.
PSOARING Patient Images. 2022. 10. Bissonnette R, Strober B, Lebwohl M, et al.
Tapinarof cream 1% once daily for plaque psoriasis: patient-reported outcomes from two pivotal phase 3
trials. Poster presented at: American Academy of Dermatology; March 19–23, 2021; San Francisco, CA.
11. Organon DOF. CSP-DMVT-505-3001. A phase 3 efficacy and safety study of tapinarof
for the treatment of plaque psoriasis in adults. 2019. 12. Bissonnette R, Stein Gold L,
Rubenstein DS, Tallman AM, Armstrong A. Tapinarof in the treatment of psoriasis: a review of the unique
mechanism of action of a novel therapeutic aryl hydrocarbon receptor—modulating agent. J Am Acad
Dermatol. 2021;84(4):1059-1067. 13. Smith SH, Jayawickreme C, Rickard DJ, et
al. Tapinarof is a natural AhR agonist that resolves skin inflammation in mice and humans. J Invest
Dermatol. 2017;137:2110-2119. 14. Greb JE, Goldminz AM, Elder JT, et al.
Psoriasis. Nat Rev Dis Primers. 2016;2:16082. 15. Rendon A, Schäkel K.
Psoriasis pathogenesis and treatment. Int J Mol Sci. 2019;20(6):1475. 16. Kim BE,
Howell MD, Guttman E, et al. TNF-α downregulates filaggrin and loricrin through c-Jun N-terminal kinase:
role for TNF-α antagonists to improve skin barrier. J Invest Dermatol. 2011;131:1272-1279.
17. Cannavò SP, Riso G, Casciaro M, Di Salvo E, Gangemi S. Oxidative stress involvement
in psoriasis: a systematic review. Free Radic Res. 2019;53(8):829-840. 18. Dietrich C.
Antioxidant functions of the aryl hydrocarbon receptor. Stem Cell Int. 2016:7943495.
19. Organon DOF. The effect of GSK2894512 on the Th2 polarization of human CD4+ T cells
and on IL-8 release from TLR2-stimulated keratinocytes. 2015. 20. Bissonnette R, Poulin
Y, Zhou Y, et al. Efficacy and safety of topical WBI-1001 in patients with mild to severe atopic
dermatitis: results from a 12-week multicentre, randomized, placebo-controlled double-blind trial. Br J
Derm. 2012;166(4):853-860. 21. Bagel J, Stein Gold L, Del Ross J, et al. Tapinarof
cream 1% once daily for the treatment of plaque psoriasis: Patient-reported outcomes from the PSOARING 3
trial. J Am Acad Dermatol. 2023;89:936-44. 22. Organon DOF. GSK2894512A:
Formulation Development Report. 2018. 23. Sofen H, Tyring S, Johnson SM, et al.
Efficacy of tapinarof cream 1% once daily for the treatment of mild to severe intertriginous plaque
psoriasis. Poster presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas,
NV. 24. Sofen H, Tyring S, Johnson SM, et al. Tapinarof cream 1% once daily improves
patient-reported outcomes in the treatment of mild to severe intertriginous plaque psoriasis. Poster
presented at: Fall Clinical Dermatology Conference; October 19-22, 2023; Las Vegas, NV.
25. Organon DOF. DMVT-505-4001 iPsO Patient Images. 2023 26. Strober
B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment
of plaque psoriasis: Results from the PSOARING 3 trial. J Am Acad Dermatol. 2022; 87:800-806.
27. Organon DOF. CSR-DMVT-505-3003. A long-term, open-label extension study to evaluate
the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. 2021.
28. Organon DOF. PSOARING 3 entering with or achieving PGA 0 or 1; Jan 2024.
29. Stein Gold L, Lewitt GM, Lockshin B, et al. Tapinarof cream 1% once daily is
efficacious in the treatment of mild to severe plaque psoriasis in the head and neck region. Poster
presented at: Winter Clinical Dermatology Conference; January 12-17, 2024; Honolulu, HI.
30. Lewitt GM, Stein Gold L, Lockshin B, et al. Tapinarof 1% cream improves
patient-reported outcomes in the treatment of mild to severe plaque psoriasis in the head and neck
region. Poster presented at: Winter Clinical Dermatology Conference; January 12-17, 2024; Honolulu, HI.
31. Organon DOF. 4002 Head & Neck Plaque Psoriasis Phase 4. 2023.
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VTAMA® (tapinarof) cream, 1% is now approved for
patients with atopic dermatitis down to 2 years of age.
No thanks, take me to the healthcare professionals VTAMA cream website for adults with plaque psoriasis.
VTAMA® (tapinarof) cream, 1% is now
approved for patients with atopic dermatitis down to 2 years of age.
No thanks,
take me to the healthcare professionals VTAMA cream
website for adults with
plaque psoriasis.
IMPORTANT SAFETY INFORMATION
Indications: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon
receptor agonist indicated for:
- the topical treatment of plaque psoriasis in adults.
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older.
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.
Robert, 36
Not an actual patient
Your adventurous patient
• Concerned about plaque psoriasis flare-ups limiting his active
lifestyle. During a flare-up, his affected BSA can go up to 5% and his PGA score is 3
(moderate)
• Wants something to help keep his psoriasis plaques clearer so
he doesn’t have to worry about them
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Next 
Emily, 51
Not an actual patient
Your active and public‑facing patient
• Works in a public-facing job and is self-conscious about her
appearance when having a plaque psoriasis flare
• Has mild plaque psoriasis and is not a candidate for
biologics
- Her plaques affect 3% of her body surface area (BSA), but they are concentrated around her face and neck
- She has a PGA score of 2 (mild)
• Cycled through different over-the-counter steroid creams, which
did not give her the results she was looking for
• Does a lot of research but relies on her dermatologist for her
best options
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Next
Carlos, 55
Not an actual patient
Your patient with sensitive skin
• Has an affected BSA of 10%, and psoriasis plaques are
concentrated in sensitive areas
- His PGA score is 4 (severe)
• Has psoriasis plaques on sensitive areas of his body, including
his genitals, causing embarrassment
• Felt topical corticosteroids were not the right option for him
due to his treatment area
• Wants to get back to socializing and dating without worrying
about psoriasis plaques
Previous
Next
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%BSA, percent of total body surface area; BSA, body surface area; PGA, Physician Global Assessment; QD, once daily.
*Pivotal studies started in 2019.
†Patients with PGA of 2 (mild) and PGA of 4 (severe) limited to ~10% each of the total randomized population; ~80% of the total randomized population had PGA of 3 (moderate).
Reference: 1. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229.
*Pivotal studies started in 2019.
†Patients with PGA of 2 (mild) and PGA of 4 (severe) limited to ~10% each of the total randomized population; ~80% of the total randomized population had PGA of 3 (moderate).
Reference: 1. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229.
- Follow-up every 4 weeks, regardless of treatment group3
- Off treatment: patients who entered the open-label LTE or achieved PGA=0 during the open-label LTE had VTAMA cream treatment temporarily discontinued3
- On treatment: patients entering the open-label LTE with PGA≥1 or with disease worsening during the LTE (PGA≥2) were treated with VTAMA cream until PGA=0 was achieved (or week 40)3
*Patients electing not to participate in the open-label LTE had a follow-up visit 4 weeks after completion
of their treatment period.
†Four patients (3 on VTAMA cream, 1 on vehicle) did not have a baseline PGA and are listed as missing.
†Four patients (3 on VTAMA cream, 1 on vehicle) did not have a baseline PGA and are listed as missing.
- Follow-up every 4 weeks, regardless of treatment group3
- Off treatment: patients who entered the open-label LTE with or achieved PGA=0 during the open-label LTE had VTAMA cream treatment temporarily discontinued3
- On treatment: patients entering the open-label LTE with PGA≥1 or with disease worsening during the LTE (PGA≥2) were treated with VTAMA cream until PGA=0 was achieved (or week 40)3
- Follow-up every 4 weeks, regardless of treatment group3
- Off treatment: patients who entered the open-label LTE or achieved PGA=0 during the open-label LTE had VTAMA cream treatment temporarily discontinued3
- On treatment: patients entering the open-label LTE with PGA≥1 or with disease worsening during the LTE (PGA≥2) were treated with VTAMA cream until PGA=0 was achieved (or week 40)3
LTE, long-term extension.
*Patients electing not to participate in the open-label LTE had a follow-up visit 4 weeks after completion of their treatment period.
†Four patients (3 on VTAMA cream, 1 on vehicle) did not have a baseline PGA and are listed as missing.
References: 1. Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;87(4):800-806. 2. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. 3. Strober B, Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Supplementary materials. J Am Acad Dermatol. 2022;87(4):800-806.
*Patients electing not to participate in the open-label LTE had a follow-up visit 4 weeks after completion of their treatment period.
†Four patients (3 on VTAMA cream, 1 on vehicle) did not have a baseline PGA and are listed as missing.
References: 1. Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;87(4):800-806. 2. Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. 3. Strober B, Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Supplementary materials. J Am Acad Dermatol. 2022;87(4):800-806.
*Plaque psoriasis was stable in intertriginous areas for ≥3 months prior to trial.
*Plaque psoriasis was stable in the head and neck region for ≥3 months prior to trial.
Adverse Events Occurring in ≥1% of Patients in Both 12-Week Pivotal Studies
-
Low rates of treatment discontinuation: 2.8% of patients discontinued treatment due to folliculitis and
2.9%
discontinued due to contact dermatitis1,6
- Study discontinuation: Of those randomized to receive VTAMA cream, 1.8% and 0.9% withdrew from the study due to folliculitis, 1.5% and 2.0% withdrew due to contact dermatitis in PSOARING 1 and 2, respectively
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