Desai Seemal R, Stein Gold Linda, Cameron Michael C, Golant Alexandra, Lewitt G Michael, Bruno Matthew J, Martin George, Brown Philip M, Rubenstein David S, Butners Victoria, Tallman Anna M
Department of Dermatology, The University of Texas Southwestern Medical Center, 5939 Harry Hines Blvd 4th Floor, Suite 100, Dallas, TX, USA.
Innovative Dermatology, Plano, TX, USA.
Dermatol Ther (Heidelb). 2023 Oct;13(10):2443-2460. doi: 10.1007/s13555-023-01008-9. Epub 2023 Sep 11.
Tapinarof cream 1% (VTAMA; Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) to treat plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age, and for atopic dermatitis in adults and children down to 2 years of age. The PSOARING phase 3 clinical trial program evaluated tapinarof cream 1% once daily (QD) in adults with mild to severe plaque psoriasis for up to 52 weeks (NCT03956355, NCT03983980, NCT04053387). Here we present case photography documenting outcomes in the PSOARING trials. Cases illustrate various outcomes across different body areas, including responses meeting the formal FDA-mandated regulatory endpoint of a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points from baseline at week 12, meaningful clinical improvement not meeting this formal endpoint, patient-reported outcomes, and pre-specified adverse events of special interest (AESIs). Tapinarof cream 1% QD demonstrated rapid and highly statistically significant efficacy, with improvements in disease activity and quality of life. In addition, a high rate (40.9%; n = 312/763) of complete disease clearance (PGA = 0) was achieved, and improvements exceeding National Psoriasis Foundation treatment goals were demonstrated. After first achieving complete disease clearance (PGA = 0), patients treated with tapinarof experienced an approximately 4-month remittive effect off therapy. Incidence and severity of folliculitis and contact dermatitis AESIs were generally mild or moderate, localized to the site of application, and associated with low discontinuation rates. Medical images are of importance in trials of dermatologic therapies to inform clinical decision-making and enhance patient assessment. Tapinarof cream 1% QD is efficacious and well tolerated in patients with mild to severe plaque psoriasis, with clinically relevant improvements seen early in the course of treatment.Clinicaltrials.gov numbers: NCT03956355, NCT03983980, NCT04053387.
1% 他扎罗芬乳膏（VTAMA；Dermavant Sciences公司）是一种非甾体类局部芳烃受体激动剂，已获美国食品药品监督管理局（FDA）批准用于治疗成人斑块状银屑病，目前正在研究用于治疗2岁及以上儿童银屑病以及2岁及以上成人和儿童特应性皮炎。PSOARING 3期临床试验项目评估了1%他扎罗芬乳膏每日一次（QD）治疗轻至重度斑块状银屑病成人患者长达52周的疗效（NCT03956355、NCT03983980、NCT04053387）。在此，我们展示PSOARING试验中记录结果的病例照片。病例说明了不同身体部位的各种结果，包括达到FDA规定的正式监管终点，即医师整体评估（PGA）评分为0（清除）或1（几乎清除），且在第12周时较基线至少降低2分；有意义的临床改善但未达到该正式终点；患者报告的结果；以及预先指定的特别关注不良事件（AESIs）。1%他扎罗芬乳膏QD显示出快速且具有高度统计学意义的疗效，疾病活动度和生活质量均有改善。此外，实现了较高的完全疾病清除率（40.9%；n = 312/763，PGA = 0），且证明改善程度超过了美国国家银屑病基金会的治疗目标。首次实现完全疾病清除（PGA = 0）后，接受他扎罗芬治疗的患者在停药后有大约4个月的缓解期。毛囊炎和接触性皮炎AESIs的发生率和严重程度一般为轻度或中度，局限于用药部位，且停药率较低。医学图像在皮肤病治疗试验中对于指导临床决策和加强患者评估具有重要意义。1%他扎罗芬乳膏QD在轻至重度斑块状银屑病患者中疗效显著且耐受性良好，在治疗早期即可观察到临床相关改善。Clinicaltrials.gov编号：NCT03956355、NCT03983980、NCT04053387。
