中重度特应性皮炎患者从度普利尤单抗转换为阿布昔替尼治疗：JADE DARE研究中使用度普利尤单抗治疗后疗效的事后分析
Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE.
作者信息
Silverberg Jonathan I, Simpson Eric L, Pink Andrew E, Weidinger Stephan, Chan Gary, Biswas Pinaki, Clibborn Claire, Güler Erman
机构信息
The George Washington University School of Medicine and Health Sciences, 2300 I St NW, Washington, DC, USA.
Oregon Health and Science University, 3303 SW Bond Ave, Portland, OR, USA.
出版信息
Dermatol Ther (Heidelb). 2025 Feb;15(2):367-380. doi: 10.1007/s13555-024-01320-y. Epub 2025 Feb 4.
INTRODUCTION
Primary results of the JADE DARE trial (NCT04345367) demonstrated that abrocitinib was superior to dupilumab in reducing the signs and symptoms of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with moderate-to-severe AD who were responders or nonresponders to dupilumab using various definitions of response.
METHODS
Data included dupilumab-treated patients from JADE DARE who switched to abrocitinib 200 mg when enrolled in the ongoing JADE EXTEND trial (NCT03422822). For this analysis, various response criteria at Week 26 of JADE DARE were defined post hoc based on Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) scores or responses. Efficacy was analyzed at Week 12 of JADE EXTEND based on patients' fulfillment of the various response criteria at Week 26 of JADE DARE. EASI scores and percentage changes from baseline in EASI and PP-NRS at Week 26 in JADE DARE were compared with the corresponding scores and percentage changes at Week 12 in EXTEND. Safety was assessed.
RESULTS
Of 365 dupilumab-treated patients in JADE DARE, 316 were enrolled in JADE EXTEND and 312 received abrocitinib 200 mg. Most dupilumab responders for IGA, EASI, PP-NRS, and DLQI at DARE Week 26 maintained their responses 12 weeks after switching to abrocitinib, while a considerable proportion of IGA, EASI, PP-NRS, or DLQI dupilumab nonresponders gained response after switching to abrocitinib. Lower EASI scores and greater percentage changes from baseline in EASI and PP-NRS scores were observed with abrocitinib at EXTEND Week 12 than with dupilumab at DARE Week 26. No new safety signals were observed.
CONCLUSION
Abrocitinib 200 mg may be an effective treatment option for patients with moderate-to-severe AD who do not achieve an optimal response with dupilumab treatment.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov: NCT04345367 (JADE DARE) and NCT03422822 (JADE EXTEND).
简介
JADE DARE试验（NCT04345367）的主要结果表明，在减轻中重度特应性皮炎（AD）的体征和症状方面，阿布昔替尼优于度普利尤单抗。这项事后分析使用了多种反应定义，评估了阿布昔替尼在度普利尤单抗反应者或无反应者的中重度AD患者中的疗效和安全性。
方法
数据包括来自JADE DARE的接受度普利尤单抗治疗的患者，这些患者在参加正在进行的JADE EXTEND试验（NCT03422822）时换用了200mg阿布昔替尼。对于本分析，JADE DARE第26周的各种反应标准是根据研究者整体评估（IGA）、湿疹面积和严重程度指数（EASI）、瘙痒峰值数字评定量表（PP-NRS）和皮肤病生活质量指数（DLQI）评分或反应事后定义的。根据患者在JADE DARE第26周满足各种反应标准的情况，在JADE EXTEND第12周分析疗效。比较了JADE DARE第26周的EASI评分以及EASI和PP-NRS相对于基线的百分比变化与EXTEND第12周的相应评分和百分比变化。评估了安全性。
结果
在JADE DARE中接受度普利尤单抗治疗的365例患者中，316例参加了JADE EXTEND，312例接受了200mg阿布昔替尼治疗。在DARE第26周时，大多数IGA、EASI、PP-NRS和DLQI方面的度普利尤单抗反应者在换用阿布昔替尼12周后仍保持反应，而相当一部分IGA、EASI、PP-NRS或DLQI方面的度普利尤单抗无反应者在换用阿布昔替尼后获得了反应。与DARE第26周使用度普利尤单抗相比，EXTEND第12周使用阿布昔替尼时观察到更低的EASI评分以及EASI和PP-NRS评分相对于基线更大的百分比变化。未观察到新的安全信号。
结论
对于度普利尤单抗治疗未达到最佳反应的中重度AD患者而言，200mg阿布昔替尼可能是一种有效的治疗选择。
临床试验注册
Clinicaltrials.gov：NCT04345367（JADE DARE）和NCT03422822（JADE EXTEND）。
Zotero 插件