Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis From Two Phase 3 Studies.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-03-29 DOI:10.1007/s13555-025-01381-7

Julien Seneschal, Albert Wolkerstorfer, Seemal R Desai, Pearl Grimes, Khaled Ezzedine, Amit G Pandya, Deanna Kornacki, Shaoceng Wei, Thierry Passeron, David Rosmarin

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引用次数: 0

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: NCT04052425/NCT04057573.

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简介两项3期试验（TRuE-V1和TRuE-V2）表明，Janus激酶（JAK）1/JAK2抑制剂ruxolitinib的外用制剂与载体霜相比，能显著改善青少年和成年白癜风患者的再色素沉着。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使用载体乳膏或1.5%芦可利替尼乳膏，每天两次，持续24周，之后所有患者均可使用芦可利替尼乳膏至第52周。疗效评估采用第52周时面部白癜风面积评分指数[F-VASI75]较基线改善≥75%的结果。安全性评估包括治疗突发不良事件（AEs）和治疗相关不良事件的发生频率：TRuE-V研究共招募了674名患者。在第52周，50.3%（176/350）的患者在整个治疗过程中使用了鲁索利替尼乳膏，28.2%（46/163）的患者在第24周后从药物转为使用鲁索利替尼乳膏，他们的F-VASI75达到了75。无论患者的年龄、性别、菲茨帕特里克皮肤类型、受累面部体表面积、病程、病情稳定性和先前治疗状况如何，各亚组都观察到了F-VASI75反应。52.1%的患者（332/637）发生了治疗引发的AEs，13.7%的患者（87/637）发生了治疗相关的AEs；不同人口亚组的发生率基本相似：结论：无论基线人口统计学或临床特征如何，使用鲁索利替尼乳膏的青少年和成人白癜风患者均能在1年后根据F-VASI75反应获得有临床意义的色素再沉着。Ruxolitinib乳膏的耐受性良好，各亚组治疗引起的和治疗相关的AE发生率相似：NCT04052425/NCT04057573.

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.