DISCLOSURES
All the authors are employees of Dermavant Science, Inc.
REFERENCES
1. Chovatiya R, Silverberg JI. Pathophysiology of atopic dermatitis and psoriasis: implications for management in children. Children (Basel). 2019;6(10):108. doi:10.3390/children6100108
2. 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.
3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116- 132.
4. Bissonnette R, Stein Gold L, Rubenstein DS, et al. 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.
5. Dermavant Sciences, Inc. FDA Approves Dermavant's VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years. 2022. Available at: https://www.dermavant.com/u-s-fda-approves-our-novel-topicaltreatment- for-adults-with-plaque-psoriasis/. Accessed June 10, 2022.
6. Paller AS, Gold LS, Soung J, et al. Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis. J Am Acad Dermatol. 2021;84(3):632-638.
7. Peppers J, Paller AS, Maeda-Chubachi T, et al. A phase 2, randomized dosefinding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019;80(1):89-98. e3.
8. Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl hydrocarbon receptor in atopic dermatitis and psoriasis. Int J Mol Sci. 2019;20(21):5424. 9. 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(10):2110-2119.
10. 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.
11. Strober B. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: A Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent. Oral presented at: European Academy of Dermatology and Venereology; September 29 - October 2 2021; Virtual.
12. U.S. Food and Drug Administration. S10 Photosafety Evaluation of Pharmaceuticals. Guidance for Industry. 2015. Available at: https://www. fda.gov/regulatory-information/search-fda-guidance-documents/s10- photosafety-evaluation-pharmaceuticals. Accessed May 31, 2022.
13. U.S. Food and Drug Administration. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry. 2018. Available at: https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/assessing-irritation-and-sensitizationpotential- transdermal-and-topical-delivery-systems-andas. Accessed May 31, 2022.
14. Berger S R, Bowman P J. A reappraisal of the 21-day cumulative irritation test in man. J Toxicol Cutaneous Ocul Toxicol. 1982;1(2):109-115.
15. Gold LS, Bhatia N, Tallman AM, Rubenstein DS. A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: secondary efficacy and patient-reported outcomes. J Am Acad Dermatol. 2021;84(3):624-631.
16. Al-Janabi A, Foulkes AC, Mason K, et al. Phenotypic switch to eczema in patients receiving biologics for plaque psoriasis: a systematic review. J Eur Acad Dermatol Venereol. 2020;34(7):1440-1448.
2. 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.
3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116- 132.
4. Bissonnette R, Stein Gold L, Rubenstein DS, et al. 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.
5. Dermavant Sciences, Inc. FDA Approves Dermavant's VTAMA® (tapinarof) cream, 1% for the Treatment of Plaque Psoriasis in Adults: First Topical Novel Chemical Entity Launched for Psoriasis in the U.S. in 25 Years. 2022. Available at: https://www.dermavant.com/u-s-fda-approves-our-novel-topicaltreatment- for-adults-with-plaque-psoriasis/. Accessed June 10, 2022.
6. Paller AS, Gold LS, Soung J, et al. Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis. J Am Acad Dermatol. 2021;84(3):632-638.
7. Peppers J, Paller AS, Maeda-Chubachi T, et al. A phase 2, randomized dosefinding study of tapinarof (GSK2894512 cream) for the treatment of atopic dermatitis. J Am Acad Dermatol. 2019;80(1):89-98. e3.
8. Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl hydrocarbon receptor in atopic dermatitis and psoriasis. Int J Mol Sci. 2019;20(21):5424. 9. 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(10):2110-2119.
10. 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.
11. Strober B. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: A Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent. Oral presented at: European Academy of Dermatology and Venereology; September 29 - October 2 2021; Virtual.
12. U.S. Food and Drug Administration. S10 Photosafety Evaluation of Pharmaceuticals. Guidance for Industry. 2015. Available at: https://www. fda.gov/regulatory-information/search-fda-guidance-documents/s10- photosafety-evaluation-pharmaceuticals. Accessed May 31, 2022.
13. U.S. Food and Drug Administration. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs. Guidance for Industry. 2018. Available at: https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/assessing-irritation-and-sensitizationpotential- transdermal-and-topical-delivery-systems-andas. Accessed May 31, 2022.
14. Berger S R, Bowman P J. A reappraisal of the 21-day cumulative irritation test in man. J Toxicol Cutaneous Ocul Toxicol. 1982;1(2):109-115.
15. Gold LS, Bhatia N, Tallman AM, Rubenstein DS. A phase 2b, randomized clinical trial of tapinarof cream for the treatment of plaque psoriasis: secondary efficacy and patient-reported outcomes. J Am Acad Dermatol. 2021;84(3):624-631.
16. Al-Janabi A, Foulkes AC, Mason K, et al. Phenotypic switch to eczema in patients receiving biologics for plaque psoriasis: a systematic review. J Eur Acad Dermatol Venereol. 2020;34(7):1440-1448.
AUTHOR CORRESPONDENCE
Stephen C. Piscitelli PharmD steve.piscitelli@dermavant.com
