Possible Drug Vacation with Adult Plaque Psoriasis Topical Treatment

Plaque psoriasis is a chronic, immune-mediated skin disorder where several mechanisms in the skin become dysregulated.¹ This dysregulation leads to chronic inflammation along with immune cell response, skin barrier dysfunction, and oxidative stress.^2-6 For mild-to-moderate and moderate-to-severe plaque psoriasis, the American Academy of Dermatology and National Psoriasis Foundation recommend topical therapies.^7-10

Although topicals are widely used, some patients with plaque psoriasis are dissatisfied with their current topical treatment options, and this may result in poor adherence, disease progression, and impact on quality of life.¹¹ Most topicals provide disease control while on therapy, but some may not be suitable for long-term use.^12-15 An unmet medical need exists for a topical treatment that is effective and safe for long-term use, even in sensitive skin areas. Additionally, it may be beneficial to have an option that may also give patients the opportunity to take a “drug vacation” and experience clearer skin, even while off-treatment. 

VTAMA (tapinarof) cream, 1% helped adult patients with mild, moderate, and severe plaque psoriasis achieve significantly clearer skin.^16-19

VTAMA cream was approved by the U.S. Food and Drug Administration (FDA) in 2022 and is a once-daily, steroid-free cream indicated for the topical treatment of plaque psoriasis in adults.^16,20,21

The approval of VTAMA cream was based on PSOARING 1 and 2, which were two identical phase 3 pivotal studies that enrolled more than 1,000 adult patients with mild, moderate, and severe plaque psoriasis. The primary endpoint for both studies was Physician Global Assessment (PGA) treatment success defined as PGA score of 0 (clear) or 1 (almost clear) and a ≥2-grade improvement from baseline at Week 12. Starting as early as 4 weeks, patients on VTAMA cream achieved significantly clearer skin than patients on vehicle. In both PSOARING 1 and 2, patients on VTAMA cream achieved 6x treatment success rate (36% and 40%) versus vehicle (6% and 6%) at Week 12.^16-19

VTAMA cream also had a favorable safety and tolerability profile even on sensitive skin areas. The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza during these 12-week pivotal studies.^16,17,22

PSOARING 3 is an open-label, long term extension study (LTE) designed to further evaluate VTAMA cream.^17,23

After completion of the two 12-week pivotal studies, 92% of eligible patients (n=763) enrolled in PSOARING 3, an open-label, LTE that evaluated the safety, efficacy, duration of remittive effect, durability of response, and tolerability of VTAMA cream.²³ 

Adult patients who entered the LTE with a PGA=0 or who achieved PGA=0 during the LTE had VTAMA cream treatment discontinued to monitor for remittive effect. Patients who entered the LTE with PGA ≥1 or those who experienced disease worsening during the LTE (PGA≥2) were treated with VTAMA cream until they achieved PGA=0 (or Week 40). The time during which treatment was discontinued is referred to as the duration of remittive effect.²³

Continued efficacy while on intermittent treatment and lasting effect even when off-treatment in the open-label, LTE.²³ 

Of the 763 enrolled patients in the LTE, 73 were completely clear (PGA=0) at the start and maintained disease control (PGA=0 or 1) for a median time of approximately 4 months (114 days) after stopping treatment. At approximately 7 months, 25% of the patients who were clear (n=73) maintained disease control (PGA=0 or 1).^16,23

In the LTE, remittive effect was observed in many more patients—in fact, a total of 312 patients (40.9%) achieved PGA=0 at least once and had a mean total duration of disease control (PGA=0 or 1) off therapy of approximately 4 months (130 days), while of the patients (n=519) entering the LTE with PGA≥2, 58.2% achieved PGA=0 or 1 at least once during the study.²³

With intermittent use of VTAMA cream, consistent clinical outcomes for adult patients achieving PGA=0 or 1 were reported, demonstrating durability of efficacy. Additionally, durability of response on therapy, with no evidence of tachyphylaxis, was demonstrated for up to 52 weeks across the studies.²³ The incidence and severity of adverse reactions in the LTE were consistent with the 12-week pivotal studies.²³

This proven remittive effect may allow a patient to take a “drug vacation,” or a break from their plaque psoriasis treatment, for up to 4 months without concern for loss of effect if and when treatment is resumed.²³ In this regard, based upon 52-weeks of clinical studies, VTAMA cream is effective for long-term use for adult patients with plaque psoriasis and may have the flexibility to pause treatment as needed and maintain disease control due to this unique and lasting off-treatment, remittive effect.²³   

VTAMA cream is the only branded prescription steroid-free topical for adult plaque psoriasis that has shown remittive effect of approximately 4 months off therapy.^16,20,23

In summary, VTAMA cream is a once-daily, steroid-free topical treatment for adults with plaque psoriasis. In two 12-week pivotal studies, the PGA success rate was 36% and 40% for patients using VTAMA cream vs 6% and 6% for patients on vehicle. In clinical studies, VTAMA cream showed a favorable and consistent safety profile and was well tolerated, even on sensitive skin areas.^3,16-20 

In an open-label, LTE, a total of 312 patients achieved PGA=0 at least once during the study and stopped using VTAMA cream. The mean total duration of disease control (PGA=0 or 1) off therapy was approximately 4 months (130 days).²³ Thus, VTAMA cream demonstrates a remittive effect, which may allow a patient to take a “drug vacation” from their plaque psoriasis treatment for up to 4 months that could provide a sense of freedom from treatment for patients with plaque psoriasis.²³ 

Learn more at VTAMAhcp.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 www.fda.gov/medwatch or call 1-800-FDA-1088. 

End Matter 

© 2023 Dermavant Sciences, Inc. All Rights Reserved.  

All trademarks are the property of Dermavant Sciences, GmbH. US-VTAMA-2300503 

Reference List:  

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3. 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. 

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5. Kim BE, Howell MD, Guttman E, et al. TNF-α downregulates filaggrin and loricrin through c-Jun N-terminal kinase: role for the TNF-α antagonists to improve ski barrier. J Invest Dermatol. 2011;131:1272-1279.  

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7. Elmets CA, Korman NJ, Prater EF, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol. 2021;84(2):432-470.  

8. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019;81(3):775-804. 

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12. Chiricozzi A, Pitocco R, Saraceno R, Nistico SP, Giunta A, Chimenti S. New topical treatments for psoriasis. Expert Opin Pharmacother. 2014;15(4):461-470. 

13. Carrascosa JM, Theng C, Thaçi D. Spotlight on topical long-term management of plaque psoriasis. Clin Cosmet Investig Dermatol. 2020;13:495-498. 

14. Horn EJ, Domm S, Katz HI, Lebwohl M, Mrowietz U, Kragballe K; International Psoriasis Council. Topical corticosteroids in psoriasis: strategies for improving safety. J Eur Acad Dermatol Venereol. 2010;24(2):119-124. 

15. Uva L, Miguel D, Pinheiro C, et al. Mechanisms of action of topical corticosteroids in psoriasis. Int J Endocrinol. 2012;2012:561018. 

16. VTAMA (tapinarof) cream, 1%. Prescribing information. Dermavant, 2022. 

17. Lebwohl M, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Eng J Med. 2021;385(24):2219-2229. 

18. Dermavant DOF. CSR-DMVT-505-3001. A phase 3 efficacy and safety study of tapinarof for the treatment of plaque psoriasis in adults. 2020.  

19. Dermavant DOF. CSR-DMVT-505-3002. A phase 3 efficacy and safety study of tapinarof for the treatment of plaque psoriasis in adults. 2020. 

20. Armstrong AW, Bissonnette R, Brown PM, Tallman AM, Papp KA. Treat-to-target outcomes and measures of treatment success in three phase 3 trials of tapinarof cream 1% once daily for mild to severe plaque psoriasis. Poster presented at: European Academy of Dermatology and Venereology; September 7–10, 2022; Milan, IT. 

21. 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 Conference; March 19-23, 2021; virtual.  

22. 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. 

23. 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.