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他卡西醇乳膏 1%每日一次治疗轻至重度斑块状银屑病的成年人:一种针对芳烃受体的新型局部治疗药物。

Tapinarof cream 1% once daily for the treatment of adults with mild to severe plaque psoriasis: A novel topical therapy targeting the aryl hydrocarbon receptor.

机构信息

University of California Los Angeles.

Division of Pharmacy Practice, Duquesne University School of Pharmacy, Pittsburgh, Pennsylvania.

出版信息

J Manag Care Spec Pharm. 2023 Dec;29(12-a Suppl):S2-S14. doi: 10.18553/jmcp.2023.29.12-a.s2.

Abstract

Plaque psoriasis is a chronic, immunemediated skin disease characterized by scaly, erythematous, pruritic plaques. The effects of psoriasis are often debilitating and stigmatizing, significantly impacting patients' physical and psychological well-being and quality of life. Current guideline-recommended psoriasis therapies (topicals, oral systemics, and biologics) have substantial limitations that include overall efficacy, safety, tolerability, sites of application, disease severity, and duration and extent of body surface area treated. Due to these limitations, psoriasis treatment regimens often require combination therapy, especially for moderate to severe disease, leading to increased treatment burden. Psoriasis is also associated with increased indirect costs (eg, reduced work productivity), leading to greater total costs expenditures. Thus, more effective, safe, well-tolerated, and cost-effective therapeutic options are needed. Tapinarof cream 1% once daily is a first-in-class, nonsteroidal, topical aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration in 2022 for the treatment of plaque psoriasis in adults. Tapinarof cream has been evaluated in plaque psoriasis, including 2 pivotal phase 3 trials (NCT03956355 and NCT03983980) and a long-term extension trial (NCT04053387). These trials demonstrated high rates of complete skin clearance with tapinarof cream, durable effects while on treatment (a lack of tachyphylaxis for up to 52 weeks), an approximately 4-month remittive effect off therapy after achieving complete clearance and stopping treatment (ie, duration during which psoriasis does not recur off therapy), and no rebound effects after cessation of therapy. According to the US Food and Drug Administration-approved prescribing information, tapinarof may be used to treat plaque psoriasis of any severity and in any location, has no restrictions on duration of use or extent of total body surface area treated, and has no contraindications, warnings, precautions, or drug-drug interactions. Tapinarof cream is thus an efficacious, well-tolerated, steroid-free topical option that addresses many of the limitations of current recommended therapies. Here we review current knowledge on the physical, psychological, and financial burdens of plaque psoriasis and identify how the clinical profile of tapinarof cream can address key treatment gaps important in the management of plaque psoriasis and patient quality of life. In this article, we aim to assist pharmacists and other managed care practitioners by providing an evidence-based overview of tapinarof cream to support patient-centric decision-making.

摘要

斑块型银屑病是一种慢性、免疫介导的皮肤疾病,其特征为鳞屑性、红斑性、瘙痒性斑块。银屑病的影响常常使人虚弱和感到耻辱,极大地影响了患者的身心健康和生活质量。目前指南推荐的银屑病治疗方法(局部用药、口服全身治疗和生物制剂)存在许多局限性,包括总体疗效、安全性、耐受性、应用部位、疾病严重程度以及治疗的体表面积的时间和范围。由于这些局限性,银屑病的治疗方案通常需要联合治疗,尤其是对于中重度疾病,从而增加了治疗负担。银屑病还与间接费用增加(例如,工作生产力降低)相关,导致总费用支出增加。因此,需要更有效、安全、耐受性良好且具有成本效益的治疗选择。他卡西醇乳膏 1%每日一次是一种首创的、非甾体类、局部芳香烃受体激动剂,于 2022 年获得美国食品药品监督管理局批准,用于治疗成人斑块型银屑病。他卡西醇乳膏已在斑块型银屑病中进行了评估,包括 2 项关键性 3 期试验(NCT03956355 和 NCT03983980)和 1 项长期扩展试验(NCT04053387)。这些试验显示,他卡西醇乳膏有很高的完全皮肤清除率,治疗期间效果持久(长达 52 周无脱敏现象),在达到完全清除和停止治疗后约有 4 个月的缓解期(即,在停止治疗后银屑病不会复发的期间),并且在停止治疗后没有反弹效应。根据美国食品药品监督管理局批准的说明书,他卡西醇可用于治疗任何严重程度和任何部位的斑块型银屑病,无使用时间或总体表面积治疗范围的限制,并且无禁忌症、警告、注意事项或药物相互作用。因此,他卡西醇乳膏是一种有效、耐受性良好的不含皮质类固醇的局部治疗选择,可解决当前推荐疗法的许多局限性。在这里,我们回顾了斑块型银屑病的身体、心理和经济负担方面的现有知识,并确定了他卡西醇乳膏的临床特征如何解决管理斑块型银屑病和提高患者生活质量的关键治疗差距。在本文中,我们旨在通过提供基于证据的他卡西醇乳膏概述来协助药剂师和其他管理式医疗保健从业者,为以患者为中心的决策提供支持。

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