Amy S. Paller, Lawrence F. Eichenfield, Alan D. Irvine, Carsten Flohr, Andreas Wollenberg, Sébastien Barbarot, Christine Bangert, Jonathan M. Spergel, Andrew Selfridge, Pinaki Biswas, Haiyun Fan, Justine Alderfer, Melissa Watkins, Herwig Koppensteiner
{"title":"阿布替尼治疗青少年中重度特应性皮炎的综合疗效和安全性分析。","authors":"Amy S. Paller, Lawrence F. Eichenfield, Alan D. Irvine, Carsten Flohr, Andreas Wollenberg, Sébastien Barbarot, Christine Bangert, Jonathan M. Spergel, Andrew Selfridge, Pinaki Biswas, Haiyun Fan, Justine Alderfer, Melissa Watkins, Herwig Koppensteiner","doi":"10.1111/all.16512","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Abrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This analysis evaluated abrocitinib efficacy in adolescents through 112 weeks, and safety of up to 4.6 years of exposure.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Data were from adolescents in JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), REGIMEN (NCT03627767; safety analysis only), and the ongoing phase 3 extension trial, EXTEND (NCT03422822; data cutoff: September 5, 2022). Efficacy assessments included proportions of patients achieving an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) and ≥ 75%/≥ 90% improvement in Eczema Area and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Efficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions of patients treated with abrocitinib (200, 100 mg) achieved EASI-75 (85%, 83%), EASI-90 (62%, 60%), and IGA 0/1 (57%, 57%). Safety was assessed in 289 and 201 patients in the abrocitinib 200- and 100-mg arms, respectively; median exposure was 882.0 and 863.0 days. Incidence rates were numerically higher with abrocitinib 200 mg versus 100 mg, with overlapping confidence intervals for serious TEAEs (IR [95% CI]; 5.47 [3.69–7.80] vs. 3.45 [1.89–5.80]) and TEAEs leading to discontinuation (6.78 [4.80–9.31] vs. 5.39 [3.38–8.16]).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Efficacy and safety results support long-term abrocitinib use in adolescent patients.</p>\n </section>\n \n <section>\n \n <h3> Trail Registration</h3>\n \n <p>ClinicalTrials.gov Identifiers NCT03349060, NCT03575871, NCT03796676, NCT03627767, NCT03422822.</p>\n </section>\n </div>","PeriodicalId":122,"journal":{"name":"Allergy","volume":"80 8","pages":"2213-2224"},"PeriodicalIF":12.0000,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.16512","citationCount":"0","resultStr":"{\"title\":\"Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis\",\"authors\":\"Amy S. 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Efficacy assessments included proportions of patients achieving an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) and ≥ 75%/≥ 90% improvement in Eczema Area and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Efficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions of patients treated with abrocitinib (200, 100 mg) achieved EASI-75 (85%, 83%), EASI-90 (62%, 60%), and IGA 0/1 (57%, 57%). Safety was assessed in 289 and 201 patients in the abrocitinib 200- and 100-mg arms, respectively; median exposure was 882.0 and 863.0 days. Incidence rates were numerically higher with abrocitinib 200 mg versus 100 mg, with overlapping confidence intervals for serious TEAEs (IR [95% CI]; 5.47 [3.69–7.80] vs. 3.45 [1.89–5.80]) and TEAEs leading to discontinuation (6.78 [4.80–9.31] vs. 5.39 [3.38–8.16]).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>Efficacy and safety results support long-term abrocitinib use in adolescent patients.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trail Registration</h3>\\n \\n <p>ClinicalTrials.gov Identifiers NCT03349060, NCT03575871, NCT03796676, NCT03627767, NCT03422822.</p>\\n </section>\\n </div>\",\"PeriodicalId\":122,\"journal\":{\"name\":\"Allergy\",\"volume\":\"80 8\",\"pages\":\"2213-2224\"},\"PeriodicalIF\":12.0000,\"publicationDate\":\"2025-03-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1111/all.16512\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Allergy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/all.16512\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ALLERGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Allergy","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/all.16512","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ALLERGY","Score":null,"Total":0}
Integrated Efficacy and Safety Analysis of Abrocitinib in Adolescents With Moderate-to-Severe Atopic Dermatitis
Background
Abrocitinib has demonstrated long-term efficacy (48 weeks) and safety (~4 years) in adults and adolescents with moderate-to-severe atopic dermatitis (AD). This analysis evaluated abrocitinib efficacy in adolescents through 112 weeks, and safety of up to 4.6 years of exposure.
Methods
Data were from adolescents in JADE MONO-1 (NCT03349060), MONO-2 (NCT03575871), TEEN (NCT03796676), REGIMEN (NCT03627767; safety analysis only), and the ongoing phase 3 extension trial, EXTEND (NCT03422822; data cutoff: September 5, 2022). Efficacy assessments included proportions of patients achieving an Investigator's Global Assessment score of 0 or 1 (IGA 0/1) and ≥ 75%/≥ 90% improvement in Eczema Area and Severity Index (EASI-75/-90). Treatment-emergent adverse events (TEAEs) and AEs of special interest were reported as incidence rate/100 patient-years. A substudy of JADE TEEN assessed immune response to vaccination.
Results
Efficacy was assessed in 170 and 187 patients in the abrocitinib 200-mg and 100-mg arms, respectively; median exposure was 971.0 and 899.0 days. At Week 112, comparable proportions of patients treated with abrocitinib (200, 100 mg) achieved EASI-75 (85%, 83%), EASI-90 (62%, 60%), and IGA 0/1 (57%, 57%). Safety was assessed in 289 and 201 patients in the abrocitinib 200- and 100-mg arms, respectively; median exposure was 882.0 and 863.0 days. Incidence rates were numerically higher with abrocitinib 200 mg versus 100 mg, with overlapping confidence intervals for serious TEAEs (IR [95% CI]; 5.47 [3.69–7.80] vs. 3.45 [1.89–5.80]) and TEAEs leading to discontinuation (6.78 [4.80–9.31] vs. 5.39 [3.38–8.16]).
Conclusions
Efficacy and safety results support long-term abrocitinib use in adolescent patients.
期刊介绍：
Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality.
Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.
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