1% Tapinarof乳膏治疗斑块型银屑病的3期临床试验

IF 2.1 4区 医学 Q3 DERMATOLOGY
Cutis Pub Date : 2024-10-01 DOI:10.12788/cutis.1112
April W Armstrong, Robert Bissonnette, Raj Chovatiya, Tina Bhutani, Philip M Brown, Anna M Tallman, Kim A Papp
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引用次数: 0

摘要

国家银屑病基金会(NPF)的治疗目标是在治疗3个月后达到1%或下体表面积(BSA)的影响。欧洲银屑病治疗指南旨在基于银屑病面积和严重程度指数(PASI)评分的改善实现类似的目标。我们对p飞涨3期项目进行了汇总分析,该项目评估了每日1% tapinarof霜(QD)治疗长达52周的患者的治疗目标结果。我们的分析包括915例p飞涨1和p飞涨2患者,他们在接受tapinarof治疗前PGA评分为2分或更高,包括在p飞涨1和p飞涨2中接受载药,然后在p飞涨3中接受tapinarof治疗的患者。我们分析的治疗目标包括绝对BSA为1%或更低或绝对总PASI评分为3或更低的患者比例。总的来说,40%的患者在3个月内达到了严格的NPF目标,BSA在1%或更低,61%的患者在任何时候(中位数,~4个月)达到了1%或更低的BSA。此外,75%、67%和50%的患者在任何时间(中位数,~2-6个月)分别达到PASI评分3、2和1或更低。我们的研究结果表明,高比例的轻度至重度牛皮癣患者在局部tapinarof单药治疗长达1年的情况下,可以达到并超过雄心勃勃的治疗目标。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Treat-to-Target Outcomes With Tapinarof Cream 1% in Phase 3 Trials for Plaque Psoriasis.

The National Psoriasis Foundation (NPF) treatment targets aim to achieve 1% or lower body surface area (BSA) affected after 3 months of treatment. European psoriasis treatment guidelines aim to achieve similar goals based on improvements in Psoriasis Area and Severity Index (PASI) scores. We performed pooled analyses of the PSOARING phase 3 program, which evaluated treat-to-target outcomes for patients treated with tapinarof cream 1% once daily (QD) for up to 52 weeks. Our analyses included 915 patients from PSOARING 1 and PSOARING 2 who had Physician Global Assessment (PGA) scores of 2 or higher before undergoing treatment with tapinarof, including those who received the vehicle in PSOARING 1 and PSOARING 2 and then tapinarof in PSOARING 3. The treatment targets we analyzed included the proportion of patients achieving an absolute BSA of 1% or lower or an absolute total PASI score of 3 or lower. In total, 40% of patients achieved the stringent NPF target of BSA of 1% or lower within 3 months, and 61% achieved a BSA of 1% or lower at any time (median, ~4 months). Furthermore, 75%, 67%, and 50% achieved PASI scores of 3, 2, and 1 or lower, respectively, at any time (median, ~2-6 months). Our results indicated that a high percentage of patients with mild to severe psoriasis can achieve and exceed ambitious treatment targets when treated with topical tapinarof monotherapy for up to 1 year.

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来源期刊
Cutis
Cutis 医学-皮肤病学
CiteScore
1.10
自引率
0.00%
发文量
191
审稿时长
6-12 weeks
期刊介绍: Published since 1965, Cutis is a peer-reviewed clinical journal for the dermatologist, allergist, and general practitioner. The journal is published monthly and focuses on concise clinical articles that present the practical side of dermatology. Referenced in Index Medicus/MEDLINE, it is respected and enjoyed by both specialists and derm-active generalists, enabling its readers to get what they need quickly and efficiently. Furthermore, Cutis is read by more physicians actively involved in the day-to-day treatment of dermatologic conditions than any other dermatology publication. Covering a broad range of pertinent and timely topics, Cutis is written and edited by industry leaders. For information on article submissions, please see our Information for Authors.
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