A novel topical treatment for plaque psoriasis: Benvitimod/tapinarof

Abstract

To the Editor: We read with interest 2 recent letters from Assaf et al and Stein Gold et al in the Journal of the American Academy of Dermatology regarding whether 1% benvitimod cream and 1% tapinarof cream are the same medication.1Assaf J. Sarkis J. Tomb R. Tapinarof and the future of topical treatments in plaque psoriasis.J Am Acad Dermatol. 2021; 84: e283-e284Google Scholar, 2Stein Gold L. Rubenstein D.S. Peist K. Jain P. Tallman A.M. Tapinarof cream 1% once daily and benvitimod 1% twice daily are 2 distinct topical medications.J Am Acad Dermatol. 2021; 85: e201-e202Google Scholar We would like to clarify this by providing some additional information, as they are becoming a useful option for plaque psoriasis. Benvitimod cream 1% is a novel drug approved and currently marketed in China for topical treatment of mild-to-moderate plaque psoriasis.3Benvitimod for patients with psoriasis gets market approval. China Economic Net.http://en.ce.cn/main/latest/201906/28/t20190628_32474181.shtmlDate accessed: August 10, 2019Google Scholar Recently, 1% tapinarof cream has been approved for filing for market approval in the United States.4Dermavant announces FDA acceptance for filing of new drug application (NDA) for tapinarof cream for the treatment of adults with plaque psoriasis.https://www.businesswire.com/news/home/20210810005299/en/Dermavant-Announces-FDA-Acceptance-for-Filing-of-New-Drug-Application-NDA-for-Tapinarof-Cream-for-the-Treatment-of-Adults-with-Plaque-PsoriasisDate: 2021Date accessed: August 10, 2021Google Scholar Both Assaf et al and Stein Gold et al have identified the active pharmaceutical ingredient (API) of both 1% benvitimod cream and 1% tapinarof cream to be the same medicinal substance: 3,5-dihydroxy-4-isopropylstilbene.1Assaf J. Sarkis J. Tomb R. Tapinarof and the future of topical treatments in plaque psoriasis.J Am Acad Dermatol. 2021; 84: e283-e284Google Scholar, 2Stein Gold L. Rubenstein D.S. Peist K. Jain P. Tallman A.M. Tapinarof cream 1% once daily and benvitimod 1% twice daily are 2 distinct topical medications.J Am Acad Dermatol. 2021; 85: e201-e202Google Scholar In 2011, for early-stage evaluations of the API, an oil-in-water cream was developed, and 2 randomized double-blind phase 2 trials were conducted independently but with similar protocols in China and Canada. The study drugs were applied twice daily in patients with plaque psoriasis. In the China trial, 365 patients were randomized, and the results showed that 52.5% of patients in the benvitimod group achieved a 75% reduction in the Psoriasis Area and Severity Index score at the end of treatment, which is similar to the Canadian trial result in which 50.0% of patients achieved 75% reduction. Highly comparable safety profiles were obtained in both trials (Genhui Chen, PhD, Personal communications: Dr.Chen is the co-inventor of benvitimod [PCT/CA00/01433] leading to the drug development programs. He was also the co-founder and CEO of the Canadian developer and the licensor, Welichem Biotech Inc. from which the drug development program was initiated and the commercial rights obtained by GlaxoSmithKline [later, by Dermavant Sciences Inc.]). Following the encouraging clinical results of these 2 trials, along with other favorable features of the API, a subsequent licensing of commercial rights by the Canadian company to GlaxoSmitheKline took place, resulting in 2 separate developmental programs of the API inside and outside of China (Genhui Chen, PhD). At the 2017 annual meeting of the American Academy of Dermatology, we reported the results of a pivotal phase 3 trial, in which 686 patients with mild-to-moderate plaque psoriasis were included.5Frellick M. New topical for mild to moderate psoriasis in the works. Medscape.https://www.medscape.com/viewarticle/876659Date: 2017Date accessed: August 9, 2021Google Scholar In this head-to-head comparative trial, patients were randomized to 1% of benvitimod cream, 0.005% calcipotriol ointment, or placebo twice daily for 12 weeks. Fifty-nine patients were followed up for an additional 40 weeks in an extension study. The results showed that the efficacy of 1% benvitimod cream was superior to placebo in the Physician global assessment and the Psoriasis Area and Severity Index score improved. In addition, the Psoriasis Area and Severity Index score of 75% was achieved in 50.4% patients in the benvitimod group, which was significantly higher than that in calcipotriol group (38.5%; P < .05). In the extension trial, treatment with 1% benvitimod cream resulted in a median remission period of 36 weeks. Similar profiles of high efficacy and long remission period were confirmed recently by Stein Gold et al in 2 phase 3 trials in North America. In 2019, 1% benvitimod cream was approved as a topical drug for the treatment of mild-to-moderate plaque psoriasis in China. During the following 2 years, 1% benvitimod cream has been used widely and received positive responses from both the medical community and patients with psoriasis. Regardless of the name under which it is distributed (1% benvitimod or 1% tapinarof) and despite the minor differences between the final products developed by different companies, it is certain that this novel medication will become a useful treatment option for patients with plaque psoriasis. Drs Zhang, Cai, and Zheng are consultants with honorarium and investigators for Beijing Wenfeng Tianji Pharma Ltd.