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：白癜风是一种常见的自身免疫性疾病，可导致皮肤及毛发色素脱失。贾纳斯激酶（Janus kinase, JAK）1/2抑制剂芦可替尼（ruxolitinib）乳膏在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，但当前真实世界相关数据仍较为有限。
研究目的：本研究旨在评估芦可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。
研究方法：本研究为单中心、单臂、观察性真实世界研究，患者每日两次外用1.5%芦可替尼乳膏，疗程为24周（每2周最大用药剂量为100g）。本研究的主要终点为第24周时面部白癜风面积评分指数（Facial Vitiligo Area Scoring Index, F-VASI）较基线改善≥75%（即F-VASI 75）。
研究结果：本研究共纳入111例患者，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用药部位瘙痒（33.3%）、用药部位痤疮（31.5%）、上呼吸道感染（22.5%）及用药部位脱屑（18.9%）。
研究局限：本研究的局限性包括样本量较小及随访周期较短。
研究结论：本研究证实，在真实世界场景下，芦可替尼乳膏可作为中国非节段型白癜风患者安全且有效的治疗选择。

搜集汇总

背景与挑战

背景概述

该数据集总结了一项关于鲁索替尼乳膏在中国非节段性白癜风患者中有效性和安全性的真实世界研究。研究显示，经过24周治疗后，49.5%的患者达到面部白癜风面积评分指数改善≥75%，主要不良反应包括应用部位瘙痒和痤疮，结论支持该药物作为一种安全有效的治疗选择。