一项针对青少年和成人特应性皮炎患者的他卡西醇乳膏治疗的 2b 期随机临床试验的疗效和患者报告结局。
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.
机构信息
Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Henry Ford Health System, Detroit, Michigan.
出版信息
J Am Acad Dermatol. 2021 Mar;84(3):632-638. doi: 10.1016/j.jaad.2020.05.135. Epub 2020 Jun 2.
BACKGROUND
Tapinarof is a topical therapeutic aryl hydrocarbon receptor modulating agent under investigation for atopic dermatitis (AD) and psoriasis treatment.
METHODS
A phase 2b, double-blind, vehicle-controlled study randomly assigned adolescents and adults with AD to receive tapinarof cream 0.5%, 1%, or vehicle, once or twice daily, for 12 weeks with a 4-week follow-up. Outcomes included Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), body surface area affected, pruritus numeric rating scale scores, patients' impressions of AD and pruritus symptom severity, and Patient-Oriented Eczema Measure (POEM) scores.
RESULTS
Overall, 191 of 247 randomized patients completed the study. Week 12 IGA responses were higher in the tapinarof groups versus the vehicle group, reaching statistical significance with tapinarof 1% twice daily, ≥75%/90% improvement in EASI from baseline were significantly higher in the tapinarof groups (except 0.5% once daily and 0.5% twice daily), EASI scores were significantly improved in all tapinarof groups, and body surface area affected was significantly reduced in the tapinarof groups (except 0.5% twice daily). More patients reported AD and pruritus symptom severity as very/moderately improved in tapinarof groups, and POEM improvements were observed in all groups. Most adverse events were mild or moderate.
LIMITATIONS
Larger prospective studies are required to confirm the reported analyses.
CONCLUSIONS
Tapinarof is a potential important advance in topical medicine development for AD.
背景
他卡西醇是一种局部治疗性芳香烃受体调节剂,目前正在研究用于治疗特应性皮炎(AD)和银屑病。
方法
一项 2b 期、双盲、安慰剂对照的研究,将 AD 青少年和成人患者随机分为接受他卡西醇乳膏 0.5%、1%或安慰剂,每天 1 次或 2 次,共 12 周,随后进行 4 周随访。主要终点为研究者整体评估(IGA)、湿疹面积和严重程度指数(EASI)、体表面积受累、瘙痒数字评分量表评分、患者对 AD 和瘙痒症状严重程度的印象以及患者导向的湿疹测量(POEM)评分。
结果
共 247 例随机患者中,191 例完成了研究。12 周时,他卡西醇组的 IGA 应答率高于安慰剂组,其中他卡西醇 1%、每天 2 次组达到统计学显著性;与基线相比,EASI 改善≥75%/90%的患者比例在他卡西醇组中更高(除 0.5%、每天 1 次组和 0.5%、每天 2 次组外),所有他卡西醇组的 EASI 评分均显著改善,体表面积受累面积在他卡西醇组中显著减少(除 0.5%、每天 2 次组外)。更多患者报告在他卡西醇组中 AD 和瘙痒症状严重程度得到了很大/中度改善,所有组均观察到 POEM 改善。大多数不良事件为轻度或中度。
局限性
需要更大规模的前瞻性研究来证实所报告的分析结果。
结论
他卡西醇是 AD 局部药物治疗领域的一项重要进展。