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vtama (tapinarof) cream 1%
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#1  Prescribed
Prescribed branded topical treatment for adults with plaque psoriasis*

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Efficacy

Safety & Tolerability

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Patient Experience

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IMPORTANT SAFETY INFORMATION

Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu).

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.

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References: 1. Dermavant DOF May 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 Rosso J, et al. Patient satisfaction with tapinarof cream 1% once daily for plaque psoriasis in a long-term extension trial. Poster presented at: Winter Clinical Dermatology Conference; January 14—19, 2022; Kauai, HI. 22. Dermavant DOF. GSK2894512A: Formulation Development Report. 2018.
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robert

Not an actual patient

Robert, 36

Your adventurous patient

carlos

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 Needs2,4

  • 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

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robert

Not an actual patient

Emily, 51

Your active and public-facing patient

carlos

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 Needs3-5

  • 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

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carlos

Not an actual patient

Carlos, 55

Your patient with sensitive skin

carlos

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 Needs2,4

  • 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.

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

Individual patient results:
Adverse Events Occurring in ≥1% of Patients in Both 12-Week Pivotal Studies
Table summarizing adverse event data from PSOARING 1 and PSOARING 2 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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