Seneschal Julien, Wolkerstorfer Albert, Desai Seemal R, Grimes Pearl, Ezzedine Khaled, Pandya Amit G, Kornacki Deanna, Wei Shaoceng, Passeron Thierry, Rosmarin David
CHU de Bordeaux, Dermatology and Pediatric Dermatology, National Reference Center for Rare 25 Skin Disorders, Hôpital Saint-André, UMR 5164, 33000, Bordeaux, France.
Univ. Bordeaux, CNRS, ImmunoConcEpT, UMR 5164, 33000, Bordeaux, France.
Dermatol Ther (Heidelb). 2025 May;15(5):1227-1238. doi: 10.1007/s13555-025-01381-7. Epub 2025 Mar 29.
Two phase 3 trials (TRuE-V1 and TRuE-V2) demonstrated that a topical formulation of the Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib significantly improved repigmentation versus vehicle cream in adolescent and adult patients with vitiligo. This post hoc analysis of pooled TRuE-V1/TRuE-V2 data evaluated efficacy and safety by baseline demographics and clinical characteristics.
Patients aged ≥ 12 years with nonsegmental vitiligo were randomized to vehicle cream or 1.5% ruxolitinib cream twice daily for 24 weeks, after which all patients could apply ruxolitinib cream through Week 52. Efficacy was evaluated using achievement of ≥ 75% improvement from baseline in facial Vitiligo Area Scoring Index [F-VASI75] at Week 52. Safety assessments included the frequency of treatment-emergent adverse events (AEs) and treatment-related AEs.
The TRuE-V studies enrolled 674 patients. Week 52 F-VASI75 was achieved by 50.3% (176/350) of patients who applied ruxolitinib cream throughout and 28.2% (46/163) who crossed over from vehicle to ruxolitinib cream after Week 24. F-VASI75 responses were observed across subgroups regardless of patient age, sex, Fitzpatrick skin type, affected facial body surface area, disease duration, disease stability, and prior treatment status. Treatment-emergent AEs occurred in 52.1% (332/637) of patients, and treatment-related AEs occurred in 13.7% (87/637); rates were generally similar across demographic subgroups.
Adolescent and adult patients with vitiligo who applied ruxolitinib cream could achieve clinically meaningful repigmentation per F-VASI75 response at 1 year, regardless of their baseline demographics or clinical characteristics. Ruxolitinib cream was well tolerated, with a similar incidence of treatment-emergent and treatment-related AEs across subgroups.
NCT04052425/NCT04057573.
两项3期试验（TRuE-V1和TRuE-V2）表明，与赋形剂乳膏相比，Janus激酶（JAK）1/JAK2抑制剂芦可替尼的外用制剂在青少年和成人白癜风患者中显著改善了色素再沉着。这项对TRuE-V1/TRuE-V2汇总数据的事后分析，根据基线人口统计学和临床特征评估了疗效和安全性。
年龄≥12岁的非节段性白癜风患者被随机分配至赋形剂乳膏组或1.5%芦可替尼乳膏组，每日两次，持续24周，之后所有患者可在第52周前使用芦可替尼乳膏。使用第52周时面部白癜风面积评分指数（F-VASI75）较基线改善≥75%来评估疗效。安全性评估包括治疗中出现的不良事件（AE）和治疗相关AE的发生率。
TRuE-V研究共纳入674例患者。在第24周后从赋形剂乳膏组转换至芦可替尼乳膏组的患者中，有28.2%（46/163）达到了第52周的F-VASI75，在整个研究期间使用芦可替尼乳膏的患者中有50.3%（176/350）达到了该指标。无论患者年龄、性别、Fitzpatrick皮肤类型、面部受累体表面积、病程、疾病稳定性和既往治疗情况如何，在各亚组中均观察到了F-VASI75反应。52.1%（332/637）的患者出现了治疗中出现的AE，13.7%（87/637）的患者出现了治疗相关AE；各人口统计学亚组的发生率总体相似。
使用芦可替尼乳膏的青少年和成人白癜风患者，无论其基线人口统计学或临床特征如何，在1年时根据F-VASI75反应均能实现具有临床意义的色素再沉着。芦可替尼乳膏耐受性良好，各亚组中治疗中出现的AE和治疗相关AE的发生率相似。
NCT04052425/NCT04057573。
