Paller Amy S, Eichenfield Lawrence F, Irvine Alan D, Flohr Carsten, Wollenberg Andreas, Barbarot Sébastien, Bangert Christine, Spergel Jonathan M, Selfridge Andrew, Biswas Pinaki, Fan Haiyun, Alderfer Justine, Watkins Melissa, Koppensteiner Herwig
Northwestern University Feinberg School of Medicine and the Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, USA.
University of California San Diego and Rady Children's Hospital-San Diego, San Diego, California, USA.
Allergy. 2025 Aug;80(8):2213-2224. doi: 10.1111/all.16512. Epub 2025 Mar 3.
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.
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.
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]).
Efficacy and safety results support long-term abrocitinib use in adolescent patients.
ClinicalTrials.gov Identifiers NCT03349060, NCT03575871, NCT03796676, NCT03627767, NCT03422822.
阿布昔替尼已在患有中度至重度特应性皮炎（AD）的成人和青少年中显示出长期疗效（48周）和安全性（约4年）。本分析评估了阿布昔替尼在青少年中长达112周的疗效以及长达4.6年暴露时间的安全性。
数据来自JADE MONO-1（NCT03349060）、MONO-2（NCT03575871）、TEEN（NCT03796676）、REGIMEN（NCT03627767；仅安全性分析）研究中的青少年患者，以及正在进行的3期扩展试验EXTEND（NCT03422822；数据截止日期：2022年9月5日）。疗效评估包括达到研究者整体评估（IGA）评分为0或1的患者比例，以及湿疹面积和严重程度指数（EASI）改善≥75%/≥90%（EASI-75/-90）的患者比例。治疗中出现的不良事件（TEAE）和特别关注的不良事件按每100患者年的发生率报告。JADE TEEN研究的一项子研究评估了对疫苗接种的免疫反应。
分别在阿布昔替尼200mg和100mg治疗组的170例和187例患者中评估了疗效；中位暴露时间分别为971.0天和899.0天。在第112周时，接受阿布昔替尼（200mg、100mg）治疗的患者达到EASI-75（85%，83%）、EASI-90（62%，60%）和IGA 0/1（57%，57%）的比例相当。分别在阿布昔替尼200mg和100mg治疗组的289例和201例患者中评估了安全性；中位暴露时间分别为882.0天和863.0天。阿布昔替尼200mg组的发生率在数值上高于100mg组，严重TEAE（发生率[95%置信区间]：5.47[3.69-7.80]对3.45[1.89-5.80]）和导致停药的TEAE（6.78[4.80-9.31]对5.39[3.38-8.16]）的置信区间有重叠。
疗效和安全性结果支持在青少年患者中长期使用阿布昔替尼。
ClinicalTrials.gov标识符NCT03349060、NCT03575871、NCT03796676、NCT03627767、NCT03422822。
