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乌帕替尼治疗中重度特应性皮炎实现最佳治疗目标和最小疾病活动度:3期研究(Measure Up 1和2)的综合分析

Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2).

作者信息

Silverberg Jonathan I, Gooderham Melinda, Katoh Norito, Aoki Valeria, Pink Andrew E, Binamer Yousef, Glick Brad, Staubach Petra, Calimlim Brian, Li Chao, Grada Ayman, Moreira Alvaro, Lee Wan-Ju, Wollenberg Andreas

机构信息

Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington DC, USA.

SKiN Centre for Dermatology, Peterborough, ON, Canada.

出版信息

Dermatol Ther (Heidelb). 2025 Jul 14. doi: 10.1007/s13555-025-01485-0.

Abstract

INTRODUCTION

The Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines recommend achieving minimal disease activity (MDA) in atopic dermatitis (AD), defined as simultaneous achievement of optimal treatment targets for at least one clinician- and one patient-reported outcome (ClinRO + PRO). We assessed the effect of upadacitinib on achieving optimal ClinROs, optimal PROs, and MDA in Measure Up 1 (NCT03569293) and Measure Up 2 (NCT3607422) studies for patients with moderate to severe AD.

METHODS

Patients were randomized to receive upadacitinib (15 mg or 30 mg) or placebo. Achievement of ≥ 1 optimal target in ClinROs, ≥ 1 optimal target in PROs, and MDA (≥ 1 optimal ClinROs and ≥ 1 optimal PROs) were reported at weeks 16 (upadacitinib vs placebo) and 52 (upadacitinib only). MDAs in selected combinations were also assessed at weeks 16 and 52. A total of 1683 and 1124 patients were included in the week 16 and 52 analysis, respectively.

RESULTS

At week 16, a significantly higher proportion of patients receiving upadacitinib (15 mg: 42.5%, 30 mg: 55.9%) compared with placebo (6.4%) achieved MDA. At week 52, 57.4% and 69.9% of patients receiving 15 mg and 30 mg of upadacitinib achieved MDA, respectively. Specifically, patients receiving upadacitinib attained higher rates of ≥ 90% reduction from baseline in Eczema Area and Severity Index (EASI 90) + Worst Pruritus-Numerical Rating Scale (WP-NRS) 0/1 at week 16 (15 mg: 25.3%, 30 mg: 39.4% vs placebo: 1.8%) and maintained at week 52 (15 mg: 38.1%, 30 mg: 46.9%).

CONCLUSION

Treatment with upadacitinib achieved both ClinRO and PRO optimal treatment targets as well as MDA and may optimize overall disease management in patients with moderate-to-severe AD.

摘要

简介

“湿疹/特应性皮炎治疗目标提升(AHEAD)”指南建议在特应性皮炎(AD)中实现最小疾病活动度(MDA),其定义为同时实现至少一项临床医生报告结局和一项患者报告结局(ClinRO + PRO)的最佳治疗目标。我们在针对中度至重度AD患者的“达标1”(NCT03569293)和“达标2”(NCT3607422)研究中评估了乌帕替尼对实现最佳ClinRO、最佳PRO和MDA的效果。

方法

患者被随机分配接受乌帕替尼(15毫克或30毫克)或安慰剂。在第16周(乌帕替尼与安慰剂对比)和第52周(仅乌帕替尼组)报告ClinRO中≥1项最佳目标、PRO中≥1项最佳目标以及MDA(≥1项最佳ClinRO和≥1项最佳PRO)的达成情况。在第16周和第52周还评估了选定组合中的MDA。第16周和第52周分析分别纳入了1683例和1124例患者。

结果

在第16周,接受乌帕替尼治疗的患者(15毫克组:42.5%,30毫克组:55.9%)实现MDA的比例显著高于安慰剂组(6.4%)。在第52周,接受15毫克和30毫克乌帕替尼治疗的患者实现MDA的比例分别为57.4%和69.9%。具体而言,接受乌帕替尼治疗的患者在第16周时达到湿疹面积和严重程度指数(EASI 90)较基线降低≥90% + 最严重瘙痒数字评定量表(WP - NRS)为0/1的比例更高(15毫克组:25.3%,30毫克组:39.4%,而安慰剂组为1.8%),并在第52周维持该水平(15毫克组:38.1%,30毫克组:46.9%)。

结论

乌帕替尼治疗实现了ClinRO和PRO的最佳治疗目标以及MDA,可能优化中度至重度AD患者的整体疾病管理。

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