- Three presentations, including two orals, will highlight the efficacy, tolerability and pharmacokinetics of VTAMA cream for the treatment of adults with plaque psoriasis
Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that data from multiple studies of VTAMA(tapinarof) cream, 1% will be presented at the 2023 American Academy of Dermatology Annual Meeting, to be held from March 17-21 in New Orleans, Louisiana.
VTAMA cream is a first-in-class, steroid free, once-daily, topical treatment that was approved for mild, moderate, and severe plaque psoriasis in adults by the U.S. Food and Drug Administration (FDA) in May 2022. In the two months following approval, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasis in adults with more than 100,000 prescriptions written to date and over 9,000 unique prescribers.1,2
The following posters will be viewable online at eposters.aad.org and onsite at the New Orleans Ernest N. Morial Convention Center. In addition, two of the posters have been selected for oral presentations during the conference, which will take place in the Exhibit Hall (Level 1, Hall E, Poster Center 1). This fall, all of the abstracts will also be published in the Journal of the American Academy of Dermatology (JAAD
Poster Presentations
Title: Tapinarof Cream 1% Once Daily (QD) for Plaque Psoriasis: Psoriasis Area and Severity Index Score by Body Region for the PSOARING 1 and 2 Trials (Accepted as Oral Presentation)
Oral Presentation Date/Time: Friday, March 17, 2:05 p.m. 2:10 p.m.
Presenter: Rocco Serrao, MD
This poster will present an analysis of efficacy by body region, including intertriginous and sensitive skin areas, for VTAMA® (tapinarof) cream, 1% versus vehicle in adults with mild to severe plaque psoriasis in the pivotal Phase 3 trials, PSOARING 1 and PSOARING 2.
Authors: Linda Stein Gold, Alexandra Golant, Rocco Serrao, Anna M. Tallman, Philip M. Brown
Title: Tapinarof Cream 1% Once Daily (QD) for Plaque Psoriasis: Post Hoc Analysis of Physician Global Assessment x Body Surface Area (PGAxBSA) Composite for the PSOARING 1 and 2 Trials (Accepted as Oral Presentation)
Oral Presentation Date/Time: Friday, March 17, 2:10 p.m. 2:15 p.m.
Presenter: Leon Kircik, MD
This poster will present data on the efficacy of VTAMA cream once-daily (QD) in PSOARING 1 and PSOARING 2 according to the product of the physician global assessment (PGA) and body surface area (BSA) (PGA×BSA), an endpoint that may provide a simpler composite measure and overcome some limitations of Psoriasis Area and Severity Index (PASI) and PGA alone.
Authors: Bruce Strober, Leon Kircik, Lawrence Green, Benjamin Lockshin, Philip M. Brown, Anna M. Tallman
Title: Tapinarof Cream 1% Once Daily for Plaque Psoriasis in Two Pivotal Phase 3 Trials: Minimal Systemic Exposure is Consistent with Adverse Event Profile
This poster will report on pharmacokinetics of VTAMA® (tapinarof) cream, 1% in adults with mild to severe plaque psoriasis in the PSOARING 1 and PSOARING 2 clinical trials. Rates of any local versus systemic adverse effects will also be reported.
Authors: Linda Stein Gold, Mark G. Lebwohl, Philip M. Brown, David S. Rubenstein, Glenn Tabolt, John E. Jett, Stephen C. Piscitelli
For more information about VTAMA (tapinarof) cream, 1%, visit VTAMA.com.
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 fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Dermavant Sciences at 1-8 DERMAVANT (1-833-762-8268).
See full Prescribing Information and Patient Information at VTAMA.com.
About Psoriasis
Impacting approximately 8 million Americans and 125 million people worldwide, psoriasis is a complex autoimmune disease meaning that the body's immune system targets and attacks its own cells.3 Plaque psoriasis, also called psoriasis vulgaris, is the most common form and affects about 80 to 90% of people with psoriasis. In people with light skin, plaque psoriasis is characterized by raised, red or pink patches of skin with silvery-white scale. People with black or brown skin are more likely to have brown or violet-colored patches with silvery-white or gray scale. The scale can be itchy, painful and disfiguring.
Psoriasis can begin at any age, but typically appears around 15 to 25 years of age and 50-60 years of age. The exact cause of psoriasis is not known, but risk factors and triggers may include genetics or a family history of psoriasis, as well as stress, smoking, heavy alcohol consumption and cold or dry weather conditions. People with psoriasis are at an increased risk of developing other health conditions, including psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. In addition to physical symptoms, psoriasis can have a significant impact on a person's quality of life and psychological health.
About Dermavant
Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant's focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company's medical dermatology pipeline includes commercialized, late-stage, and early-development product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases. Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Dermavant is also developing VTAMA cream for the treatment of atopic dermatitis in adults and children and expects to release topline results from its Phase 3 clinical trials in March and May 2023. Dermavant's pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential differentiated treatment option for immunological and inflammatory diseases with multiple potential routes of administration. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
2023 Dermavant Sciences, Inc. All rights reserved. All trademarks are the property of Dermavant Sciences, GmbH. This information including product information is intended only for residents of the United States.
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1 IQVIA National Prescription Audit (NPA) for the 3-month period ending 2/24/2023, reflecting estimates of real-world activity. All rights reserved.
2 NPA for the period 5/20/22 to 2/10/2023, reflecting estimates of real-world activity. All rights reserved.
3 National Psoriasis Foundation. Psoriasis statistics. Available at: https://www.psoriasis.org/psoriasis-statistics/.
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