阿罗西替尼可改善瘙痒型特应性皮炎患者的瘙痒症状和生活质量

Q3 Medicine
J. Silverberg, J. P. Thyssen, Irina Lazariciu, D. Myers, E. Güler, R. Chovatiya
{"title":"阿罗西替尼可改善瘙痒型特应性皮炎患者的瘙痒症状和生活质量","authors":"J. Silverberg, J. P. Thyssen, Irina Lazariciu, D. Myers, E. Güler, R. Chovatiya","doi":"10.1002/ski2.382","DOIUrl":null,"url":null,"abstract":"Patients with atopic dermatitis (AD) exhibit heterogeneous clinical phenotypes, reflecting different combinations of itch and lesional severity. AD with severe itch but clear‐moderate lesions, also known as itch‐dominant AD, is a common clinical phenotype.To evaluate abrocitinib efficacy in patients with moderate‐to‐severe AD who have itch‐dominant AD.This post hoc analysis includes pooled data from clinical trials of patients with moderate‐to‐severe AD receiving abrocitinib (100 or 200 mg) as monotherapy (phase 2b; phase 3 JADE MONO‐1 and JADE MONO‐2) or in combination with topical therapy (phase 3 JADE COMPARE). Data from the ongoing long‐term JADE EXTEND trial (data cutoff April 2020) were also evaluated. Itch‐dominant AD was defined as baseline Peak Pruritus Numerical Rating Scale (PP‐NRS) score of 7−10 and Investigator's Global Assessment of 0−3 or Eczema Area and Severity Index of 0‒21. Assessments included a ≥4‐point improvement in PP‐NRS (PP‐NRS4), PP‐NRS score of 0 (no itch) or 1 (little itch) in patients with PP‐NRS score ≥2 at baseline, ≥4‐point improvement from baseline in Patient‐Oriented Eczema Measure (POEM‐4), Patient Global Assessment (PtGA) of clear or almost clear, and Dermatology Life Quality Index (DLQI) score of 0 or 1 (no impact or little impact of AD on quality of life [QoL]).In the pooled monotherapy trials, 37% of patients had itch‐dominant AD at baseline. As early as Week 2, more patients with itch‐dominant AD achieved PP‐NRS4 with abrocitinib 100 mg (35%) and abrocitinib 200 mg (57%) versus placebo (7%); 6% and 22% versus 0%, respectively, achieved PP‐NRS 0/1. More patients achieved a PtGA of clear/almost clear at Week 12 with abrocitinib 100 mg (28%) and abrocitinib 200 mg (45%) than placebo (9%). Additionally, abrocitinib led to clinically meaningful improvements in POEM and DLQI. Most patients with itch‐dominant AD experienced itch improvement over time with abrocitinib monotherapy or with concomitant topical therapy; 86%–87% and 62%–67% of patients had no itch‐moderate itch and clear‐moderate lesions by weeks 24 and 48, respectively.Abrocitinib is highly efficacious in patients with itch‐dominant AD, demonstrating rapid, deep, and sustained improvements in itch and clinically meaningful improvements in patients' QoL.NCT02780167; NCT03349060; NCT03575871; NCT03720470; NCT03422822.","PeriodicalId":74804,"journal":{"name":"Skin health and disease","volume":"296 10","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Abrocitinib may improve itch and quality of life in patients with itch‐dominant atopic dermatitis\",\"authors\":\"J. Silverberg, J. P. Thyssen, Irina Lazariciu, D. Myers, E. Güler, R. Chovatiya\",\"doi\":\"10.1002/ski2.382\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Patients with atopic dermatitis (AD) exhibit heterogeneous clinical phenotypes, reflecting different combinations of itch and lesional severity. AD with severe itch but clear‐moderate lesions, also known as itch‐dominant AD, is a common clinical phenotype.To evaluate abrocitinib efficacy in patients with moderate‐to‐severe AD who have itch‐dominant AD.This post hoc analysis includes pooled data from clinical trials of patients with moderate‐to‐severe AD receiving abrocitinib (100 or 200 mg) as monotherapy (phase 2b; phase 3 JADE MONO‐1 and JADE MONO‐2) or in combination with topical therapy (phase 3 JADE COMPARE). Data from the ongoing long‐term JADE EXTEND trial (data cutoff April 2020) were also evaluated. Itch‐dominant AD was defined as baseline Peak Pruritus Numerical Rating Scale (PP‐NRS) score of 7−10 and Investigator's Global Assessment of 0−3 or Eczema Area and Severity Index of 0‒21. Assessments included a ≥4‐point improvement in PP‐NRS (PP‐NRS4), PP‐NRS score of 0 (no itch) or 1 (little itch) in patients with PP‐NRS score ≥2 at baseline, ≥4‐point improvement from baseline in Patient‐Oriented Eczema Measure (POEM‐4), Patient Global Assessment (PtGA) of clear or almost clear, and Dermatology Life Quality Index (DLQI) score of 0 or 1 (no impact or little impact of AD on quality of life [QoL]).In the pooled monotherapy trials, 37% of patients had itch‐dominant AD at baseline. As early as Week 2, more patients with itch‐dominant AD achieved PP‐NRS4 with abrocitinib 100 mg (35%) and abrocitinib 200 mg (57%) versus placebo (7%); 6% and 22% versus 0%, respectively, achieved PP‐NRS 0/1. More patients achieved a PtGA of clear/almost clear at Week 12 with abrocitinib 100 mg (28%) and abrocitinib 200 mg (45%) than placebo (9%). Additionally, abrocitinib led to clinically meaningful improvements in POEM and DLQI. Most patients with itch‐dominant AD experienced itch improvement over time with abrocitinib monotherapy or with concomitant topical therapy; 86%–87% and 62%–67% of patients had no itch‐moderate itch and clear‐moderate lesions by weeks 24 and 48, respectively.Abrocitinib is highly efficacious in patients with itch‐dominant AD, demonstrating rapid, deep, and sustained improvements in itch and clinically meaningful improvements in patients' QoL.NCT02780167; NCT03349060; NCT03575871; NCT03720470; NCT03422822.\",\"PeriodicalId\":74804,\"journal\":{\"name\":\"Skin health and disease\",\"volume\":\"296 10\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-05-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Skin health and disease\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/ski2.382\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Skin health and disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/ski2.382","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

摘要

特应性皮炎(AD)患者表现出不同的临床表型,反映了瘙痒和皮损严重程度的不同组合。为了评估阿罗西替尼对以瘙痒为主的中重度特应性皮炎患者的疗效,本研究对接受阿罗西替尼(100或200毫克)单药治疗(2b期;3期JADE MONO-1和JADE MONO-2)或联合局部治疗(3期JADE COMPARE)的中重度特应性皮炎患者的临床试验数据进行了汇总。此外,还对正在进行的长期 JADE EXTEND 试验(数据截止日期为 2020 年 4 月)的数据进行了评估。瘙痒主导型 AD 的定义是基线瘙痒峰值数字评定量表 (PP-NRS) 评分为 7-10 分,研究者总体评估为 0-3 分,或湿疹面积和严重程度指数为 0-21 分。评估包括:PP-NRS(PP-NRS4)改善≥4分;基线PP-NRS评分≥2分的患者PP-NRS评分为0分(无痒)或1分(少痒);患者导向湿疹测量(POEM-4)较基线改善≥4分;患者总体评估(PtGA)为无痒或基本无痒;皮肤科生活质量指数(DLQI)为0分或1分(AD对生活质量[QoL]无影响或影响不大)。在汇总的单一疗法试验中,37% 的患者在基线时以瘙痒为主。早在第2周,阿罗西替尼100毫克(35%)和阿罗西替尼200毫克(57%)与安慰剂(7%)相比,有更多的瘙痒主导型AD患者达到了PP-NRS4;分别有6%和22%与0%的患者达到了PP-NRS 0/1。与安慰剂(9%)相比,更多患者在第12周时服用阿罗西替尼100毫克(28%)和阿罗西替尼200毫克(45%)后PtGA达到 "清除/基本清除"。此外,阿罗西替尼还使POEM和DLQI得到了有临床意义的改善。大多数瘙痒为主的AD患者在接受阿罗西替尼单药治疗或同时接受局部治疗后,瘙痒症状会随着时间的推移而得到改善;到第24周和第48周时,分别有86%-87%和62%-67%的患者已无瘙痒-中度瘙痒和皮损清晰-中度皮损。阿罗昔替尼对以瘙痒为主的AD患者疗效显著,瘙痒症状得到了快速、深入和持续的改善,患者的QoL也得到了有临床意义的改善。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Abrocitinib may improve itch and quality of life in patients with itch‐dominant atopic dermatitis
Patients with atopic dermatitis (AD) exhibit heterogeneous clinical phenotypes, reflecting different combinations of itch and lesional severity. AD with severe itch but clear‐moderate lesions, also known as itch‐dominant AD, is a common clinical phenotype.To evaluate abrocitinib efficacy in patients with moderate‐to‐severe AD who have itch‐dominant AD.This post hoc analysis includes pooled data from clinical trials of patients with moderate‐to‐severe AD receiving abrocitinib (100 or 200 mg) as monotherapy (phase 2b; phase 3 JADE MONO‐1 and JADE MONO‐2) or in combination with topical therapy (phase 3 JADE COMPARE). Data from the ongoing long‐term JADE EXTEND trial (data cutoff April 2020) were also evaluated. Itch‐dominant AD was defined as baseline Peak Pruritus Numerical Rating Scale (PP‐NRS) score of 7−10 and Investigator's Global Assessment of 0−3 or Eczema Area and Severity Index of 0‒21. Assessments included a ≥4‐point improvement in PP‐NRS (PP‐NRS4), PP‐NRS score of 0 (no itch) or 1 (little itch) in patients with PP‐NRS score ≥2 at baseline, ≥4‐point improvement from baseline in Patient‐Oriented Eczema Measure (POEM‐4), Patient Global Assessment (PtGA) of clear or almost clear, and Dermatology Life Quality Index (DLQI) score of 0 or 1 (no impact or little impact of AD on quality of life [QoL]).In the pooled monotherapy trials, 37% of patients had itch‐dominant AD at baseline. As early as Week 2, more patients with itch‐dominant AD achieved PP‐NRS4 with abrocitinib 100 mg (35%) and abrocitinib 200 mg (57%) versus placebo (7%); 6% and 22% versus 0%, respectively, achieved PP‐NRS 0/1. More patients achieved a PtGA of clear/almost clear at Week 12 with abrocitinib 100 mg (28%) and abrocitinib 200 mg (45%) than placebo (9%). Additionally, abrocitinib led to clinically meaningful improvements in POEM and DLQI. Most patients with itch‐dominant AD experienced itch improvement over time with abrocitinib monotherapy or with concomitant topical therapy; 86%–87% and 62%–67% of patients had no itch‐moderate itch and clear‐moderate lesions by weeks 24 and 48, respectively.Abrocitinib is highly efficacious in patients with itch‐dominant AD, demonstrating rapid, deep, and sustained improvements in itch and clinically meaningful improvements in patients' QoL.NCT02780167; NCT03349060; NCT03575871; NCT03720470; NCT03422822.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
1.70
自引率
0.00%
发文量
0
审稿时长
10 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信