Chiesa Fuxench Zelma C, Lai Zhihong, Kuo YuTzu, Nawaz Haq, Cotliar Jonathan
Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Incyte Corporation, Wilmington, DE, USA.
J Dermatolog Treat. 2025 Dec;36(1):2480744. doi: 10.1080/09546634.2025.2480744. Epub 2025 Mar 25.
Ruxolitinib cream was evaluated in patients with facial/neck atopic dermatitis (AD) in a decentralized, double-blind, randomized clinical trial (NCT05127421).
Patients aged 12-70 years with AD (Investigator's Global Assessment [IGA] score 2/3, ≤20% affected body surface area [face/neck, ≥0.5%]) were randomized 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 4 weeks; thereafter, all patients applied as-needed ruxolitinib cream for 4 additional weeks. The primary endpoint was ≥75% improvement in head/neck Eczema Area and Severity Index (EASI-75) at Week 4 assessed by blinded central reader using photographs.
Among 77 randomized patients (median [range] age, 38.0 [17-66] y), 44.2% were Black. The mean (SD) baseline head/neck EASI was 1.2 (0.7). More patients who applied ruxolitinib cream vs vehicle achieved head/neck EASI-75 at Week 4 (37.0% vs 17.4%; = 0.091). Improvements with ruxolitinib cream vs vehicle were observed for facial/neck IGA treatment success (IGA 0/1 with ≥2-point improvement from baseline) and Patient-Oriented Eczema Measure (overall and itch). Ruxolitinib cream was well tolerated, including on the face and neck. Application site reactions were infrequent (ruxolitinib cream, 1.9% [ = 1]; vehicle, 8.7% [ = 2]).
Ruxolitinib cream improved signs and symptoms of facial/neck AD vs vehicle and was well tolerated.
在一项去中心化、双盲、随机临床试验（NCT05127421）中，对芦可替尼乳膏用于面部/颈部特应性皮炎（AD）患者进行了评估。
年龄在12 - 70岁的AD患者（研究者整体评估[IGA]评分为2/3，体表面积受累≤20%[面部/颈部，≥0.5%]）按2:1随机分组，分别每日两次使用1.5%芦可替尼乳膏或赋形剂，为期4周；此后，所有患者按需再使用芦可替尼乳膏4周。主要终点是在第4周时，由盲态的中心阅片者根据照片评估头部/颈部湿疹面积和严重程度指数（EASI - 75）改善≥75%。
在77例随机分组的患者中（中位[范围]年龄，38.0[17 - 66]岁），44.2%为黑人。基线时头部/颈部EASI的均值（标准差）为1.2（0.7）。与使用赋形剂相比，更多使用芦可替尼乳膏的患者在第4周时达到头部/颈部EASI - 75（37.0%对17.4%；P = 0.091）。在面部/颈部IGA治疗成功（IGA 0/1且较基线改善≥2分）以及患者导向性湿疹评估（总体和瘙痒）方面，观察到芦可替尼乳膏相对于赋形剂有改善。芦可替尼乳膏耐受性良好，包括在面部和颈部。用药部位反应不常见（芦可替尼乳膏，1.9%[n = 1]；赋形剂，8.7%[n = 2]）。
与赋形剂相比，芦可替尼乳膏改善了面部/颈部AD的体征和症状，且耐受性良好。
