Safety Profile | VTAMA® (tapinarof) cream, 1%

References: 1. Dermavant DOF [MyVTAMA Pharmacy Count; Jan 2023]. 2. VTAMA (tapinarof) cream, 1%. Prescribing Information. Dermavant; 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. Dermavant DOF. CSR-DMVT-505-3001. A phase 3 efficacy and safety study of tapinarof for the treatment of plaque psoriasis in adults. 2020. 7. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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. Dermavant 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.

US-VTMA-2400315

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.

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.

Not an actual patient

Robert, 36

Your adventurous patient

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

Robert’s Treatment Needs^2,4

Looking for one effective product that could be used on various parts of the body
VTAMA cream could be a good option because it’s applied once daily

View efficacy

Not an actual patient

Emily, 51

Your active and public-facing patient

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

Emily’s Treatment Needs^3-5

A non-steroidal topical option that is safe in sensitive areas like her face and neck
VTAMA cream could be a good option because it’s well tolerated in sensitive areas and delivers significantly clearer skin

View tolerability

Not an actual patient

Carlos, 55

Your patient with sensitive skin

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

Carlos’ Treatment Needs^2,4

Needs effective treatment that is also safe and well tolerated in sensitive skin areas such as face, neck, intertriginous/inframammary areas, and genitalia
VTAMA cream could be a good option because it’s well tolerated on sensitive skin areas

View tolerability

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More than 1000 patients with mild, moderate, and severe plaque psoriasis in 2 identical studies.*^2,5

Study design and primary endpoints for double-blind studies PSOARING 1 and PSOARING 2.

SChart showing the pivotal studies results

BSA, body surface area.
*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).

PSOARING 3 Study Design

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. 

PSOARING 3 Study Design

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

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. 

Intertriginous Plaque Psoriasis Study Design^23,24

*Plaque psoriasis was stable in intertriginous areas for ≥3 months prior to trial.

Head and Neck plaque psoriasis phase 4, open-label study design²⁹

Graph showing the head and neck plaque psoriasis phase 4, open-label study design

*Plaque psoriasis was stable in the head and neck region for ≥3 months prior to trial.

Individual patient results:

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 dermatitis^1,6
- 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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Safe and well
tolerated even on
sensitive skin areas

Favorable Safety Profile²

Tolerability

The science behind tapinarof

Safe and welltolerated even on sensitive skin areas

Favorable Safety Profile2

Tolerability

The science behind tapinarof

1. How likely are you to let the American Academy of Dermatology (AAD) guidelines influence your treatment decisions?

2. How likely are you to consider a branded topical treatment over a generic topical option?

3. What level of experience do you have with VTAMA cream?

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Safe and well
tolerated even on
sensitive skin areas

Favorable Safety Profile²