罗索利替尼乳膏单药治疗可迅速改善青少年和成人头颈部及其他解剖区域轻度至中度特应性皮炎的程度和体征:两项三期研究的汇总结果。

Eric L Simpson, Robert Bissonnette, Zelma C Chiesa Fuxench, Howard Kallender, Daniel Sturm, Haobo Ren, Linda F Stein Gold
{"title":"罗索利替尼乳膏单药治疗可迅速改善青少年和成人头颈部及其他解剖区域轻度至中度特应性皮炎的程度和体征:两项三期研究的汇总结果。","authors":"Eric L Simpson, Robert Bissonnette, Zelma C Chiesa Fuxench, Howard Kallender, Daniel Sturm, Haobo Ren, Linda F Stein Gold","doi":"10.1080/09546634.2024.2310633","DOIUrl":null,"url":null,"abstract":"<p><p><b>Purpose:</b> Ruxolitinib (selective Janus kinase [JAK] 1 and JAK2 inhibitor) cream demonstrated efficacy and safety in patients with atopic dermatitis (AD) in the phase 3 TRuE-AD studies. In TRuE-AD1/TRuE-AD2 (NCT03745638/NCT03745651), adults and adolescents with mild to moderate AD were randomized to apply twice-daily ruxolitinib cream or vehicle for eight weeks. Here, we evaluated the efficacy and tolerability of ruxolitinib cream by anatomic region, focusing on head/neck (HN) lesions that are typically difficult to manage and disproportionately affect quality of life (QoL).<b>Materials and methods:</b> Eczema Area and Severity Index (EASI) responses in anatomic regions were evaluated in the pooled population (<i>N</i> = 1208) and among patients with baseline HN involvement (<i>n</i> = 663). Itch, Investigator's Global Assessment (IGA), QoL, and application site tolerability were also assessed.<b>Results:</b> By Week 2 (earliest assessment), ruxolitinib cream application resulted in significant improvements across all EASI anatomic region subscores and AD signs versus vehicle, with further improvements through Week 8. Significantly more patients with HN involvement who applied ruxolitinib cream versus vehicle achieved clinically meaningful improvements in itch, IGA, and QoL. Application site reactions with ruxolitinib cream were infrequent (<3%), including in patients with HN involvement.<b>Conclusions:</b> These results support the use of ruxolitinib cream for AD treatment across all anatomic regions, including HN.</p>","PeriodicalId":94235,"journal":{"name":"The Journal of dermatological treatment","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ruxolitinib cream monotherapy demonstrates rapid improvement in the extent and signs of mild to moderate atopic dermatitis across head and neck and other anatomic regions in adolescents and adults: pooled results from 2 phase 3 studies.\",\"authors\":\"Eric L Simpson, Robert Bissonnette, Zelma C Chiesa Fuxench, Howard Kallender, Daniel Sturm, Haobo Ren, Linda F Stein Gold\",\"doi\":\"10.1080/09546634.2024.2310633\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Purpose:</b> Ruxolitinib (selective Janus kinase [JAK] 1 and JAK2 inhibitor) cream demonstrated efficacy and safety in patients with atopic dermatitis (AD) in the phase 3 TRuE-AD studies. In TRuE-AD1/TRuE-AD2 (NCT03745638/NCT03745651), adults and adolescents with mild to moderate AD were randomized to apply twice-daily ruxolitinib cream or vehicle for eight weeks. Here, we evaluated the efficacy and tolerability of ruxolitinib cream by anatomic region, focusing on head/neck (HN) lesions that are typically difficult to manage and disproportionately affect quality of life (QoL).<b>Materials and methods:</b> Eczema Area and Severity Index (EASI) responses in anatomic regions were evaluated in the pooled population (<i>N</i> = 1208) and among patients with baseline HN involvement (<i>n</i> = 663). Itch, Investigator's Global Assessment (IGA), QoL, and application site tolerability were also assessed.<b>Results:</b> By Week 2 (earliest assessment), ruxolitinib cream application resulted in significant improvements across all EASI anatomic region subscores and AD signs versus vehicle, with further improvements through Week 8. Significantly more patients with HN involvement who applied ruxolitinib cream versus vehicle achieved clinically meaningful improvements in itch, IGA, and QoL. Application site reactions with ruxolitinib cream were infrequent (<3%), including in patients with HN involvement.<b>Conclusions:</b> These results support the use of ruxolitinib cream for AD treatment across all anatomic regions, including HN.</p>\",\"PeriodicalId\":94235,\"journal\":{\"name\":\"The Journal of dermatological treatment\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Journal of dermatological treatment\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/09546634.2024.2310633\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/31 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Journal of dermatological treatment","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/09546634.2024.2310633","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/31 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

目的在 TRuE-AD 3 期研究中,Ruxolitinib(选择性 Janus 激酶 [JAK] 1 和 JAK2 抑制剂)乳膏对特应性皮炎(AD)患者的疗效和安全性得到了证实。在TRuE-AD1/TRuE-AD2(NCT03745638/NCT03745651)研究中,患有轻度至中度特应性皮炎的成人和青少年被随机分配到每天两次使用鲁索利替尼乳膏或药物,为期八周。在此,我们按解剖区域评估了Ruxolitinib乳膏的疗效和耐受性,重点是头颈部(HN)皮损,这些皮损通常难以控制,对生活质量(QoL)的影响更大:在汇总人群(1208 人)和基线 HN 受累患者(663 人)中评估解剖区域的湿疹面积和严重程度指数(EASI)反应。此外,还评估了瘙痒、研究者总体评估(IGA)、生活质量和应用部位耐受性:结果:第2周(最早的评估)时,涂抹芦可利替尼乳膏与涂抹药物相比,所有EASI解剖区域子评分和AD体征均有显著改善,第8周时进一步改善。使用芦可利替尼乳膏的 HN 受累患者在瘙痒、IGA 和 QoL 方面获得有临床意义改善的人数明显多于使用药物的患者。使用Ruxolitinib乳膏后,用药部位的反应并不常见(结论:这些结果支持使用Ruxolitinib乳膏:这些结果支持将Ruxolitinib乳膏用于包括HN在内的所有解剖区域的AD治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Ruxolitinib cream monotherapy demonstrates rapid improvement in the extent and signs of mild to moderate atopic dermatitis across head and neck and other anatomic regions in adolescents and adults: pooled results from 2 phase 3 studies.

Purpose: Ruxolitinib (selective Janus kinase [JAK] 1 and JAK2 inhibitor) cream demonstrated efficacy and safety in patients with atopic dermatitis (AD) in the phase 3 TRuE-AD studies. In TRuE-AD1/TRuE-AD2 (NCT03745638/NCT03745651), adults and adolescents with mild to moderate AD were randomized to apply twice-daily ruxolitinib cream or vehicle for eight weeks. Here, we evaluated the efficacy and tolerability of ruxolitinib cream by anatomic region, focusing on head/neck (HN) lesions that are typically difficult to manage and disproportionately affect quality of life (QoL).Materials and methods: Eczema Area and Severity Index (EASI) responses in anatomic regions were evaluated in the pooled population (N = 1208) and among patients with baseline HN involvement (n = 663). Itch, Investigator's Global Assessment (IGA), QoL, and application site tolerability were also assessed.Results: By Week 2 (earliest assessment), ruxolitinib cream application resulted in significant improvements across all EASI anatomic region subscores and AD signs versus vehicle, with further improvements through Week 8. Significantly more patients with HN involvement who applied ruxolitinib cream versus vehicle achieved clinically meaningful improvements in itch, IGA, and QoL. Application site reactions with ruxolitinib cream were infrequent (<3%), including in patients with HN involvement.Conclusions: These results support the use of ruxolitinib cream for AD treatment across all anatomic regions, including HN.

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
自引率
0.00%
发文量
0
期刊最新文献
Efficacy and safety of 308-nm Excimer lamp combined with Tacrolimus 0.1% ointment vs Tacrolimus 0.1% ointment as monotherapy in treating children with limited vitiligo: a randomized controlled trial. The wide variety of methotrexate dosing regimens for the treatment of atopic dermatitis: a systematic review. Comparing Mohs micrographic surgery and wide local excision in the management of head and neck dermatofibrosarcoma protuberans: a scoping review. The primary role of sebum in the pathophysiology of acne vulgaris and its therapeutic relevance in acne management. Paradoxical skin lesions induced by IL-17 inhibitors in SAPHO syndrome.
×
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
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 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 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1