Effectiveness and safety of ruxolitinib cream in Chinese patients with nonsegmental vitiligo

Background: Vitiligo is a common autoimmune disease resulting in skin and hair depigmentation. A cream formulation of the Janus kinase 1/2 inhibitor ruxolitinib induced significant clinical improvement in patients with nonsegmental vitiligo in phase 3 trials, but real-world data are limited.
Objective: To evaluate the effectiveness and safety of ruxolitinib cream in Chinese patients with nonsegmental vitiligo.
Methods: In this single-center, single-arm, observational, real-word study, patients applied 1.5% ruxolitinib cream twice daily for 24 weeks (maximum dosage, 100 g every 2 weeks). The primary endpoint was a ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI 75) at week 24.
Results: In total, 111 patients were enrolled, 49.5% (95% confidence interval = 39.9–59.2) of whom achieved F-VASI 75 at week 24. The most common adverse events were application-site pruritus (33.3%), application-site acne (31.5%), upper respiratory tract infection (22.5%), and application-site exfoliation (18.9%).
Limitations: This study’s limitations included its small sample size and short follow-up period.
Conclusion This study highlighted the potential of ruxolitinib cream as a safe and effective therapeutic option for nonsegmental vitiligo in the Chinese population in a real-world setting.

背景：白癜风（Vitiligo）是一类常见的自身免疫性疾病，可导致皮肤及毛发色素脱失。Janus激酶1/2（Janus kinase 1/2）抑制剂鲁索替尼（ruxolitinib）的乳膏剂型，在III期临床试验中可使非节段型白癜风患者获得显著临床改善，但相关真实世界数据较为有限。
目的：评估鲁索替尼乳膏在中国非节段型白癜风患者中的有效性与安全性。
方法：本研究为单中心、单臂观察性真实世界研究，受试者每日两次外用1.5%鲁索替尼乳膏，疗程共24周（最大给药剂量为每2周100g）。主要终点为第24周时面部白癜风面积评分指数较基线改善≥75%（F-VASI 75）。
结果：共计纳入111例受试者，其中49.5%（95%置信区间：39.9~59.2）的患者在第24周时达到F-VASI 75。最常见的不良事件为给药部位瘙痒（33.3%）、给药部位痤疮（31.5%）、上呼吸道感染（22.5%）及给药部位脱屑（18.9%）。
局限性：本研究存在样本量较小、随访周期较短的局限性。
结论：本研究证实，在真实世界场景下，鲁索替尼乳膏可作为中国非节段型白癜风患者安全有效的治疗选择。

搜集汇总

背景与挑战

背景概述

该数据集研究了1.5%鲁索替尼乳膏在中国非节段性白癜风患者中的有效性和安全性，结果显示49.5%的患者在24周后达到F-VASI 75改善，常见不良反应包括应用部位瘙痒和痤疮。研究强调了鲁索替尼乳膏在中国人群中的潜在治疗效果。