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}
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.