Ruxolitinib膏治疗白癜风:随机控制,第二阶段试验。

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Rosmarin D,迪亚AG) Lebwohl M,格兰姆斯P, Hamzavi我Gottlieb AB,巴特勒K,郭F,太阳K,霁T,豪厄尔博士哈里斯我

Ruxolitinib膏治疗白癜风:随机控制,第二阶段试验。

柳叶刀》。2020年7月11日,396 (10244):110 - 120。doi: 10.1016 / s0140 - 6736 (20) 30609 - 7。

PubMed ID
32653055 (在PubMed
]
文摘

背景:白癜风是一种慢性自身免疫性疾病导致皮肤脱色和降低生活质量。没有批准可以治疗白癜风的药物治疗和当前功效有限,强调需要改进治疗方案。我们调查ruxolitinib奶油白癜风患者的治疗潜力和报告的有效性和安全性结果52周的双盲治疗。方法:我们做了一个多中心、随机、双盲、第二阶段研究成人白癜风患者在26个美国在18个州的医院和医疗中心。褪色的0.5%或者更多的患者面部身体表面积(BSA)和3%或者更多的非面部BSA被随机分配(1:1:1:1:1)通过使用交互式响应技术系统接收ruxolitinib奶油(每天两次1.5%,1.5%每天一次,每天一次0.5%,或0.15%每天一次)或车辆(对照组)每天两次在病变构成20%或更少的BSA 24周。对照组患者除了患者的0.15%每天一次组不显示基线的25%或更高的改善面部白癜风区域得分指数(F-VASI)在24周re-randomised三种高ruxolitinib霜剂(0.5%的每天一次,1.5%的每天一次,1.5%每天两次)。每天一次病人的0.5%,1.5%每天一次,或1.5%每天两次团体保持在原来的剂量达到52周。患者、调查和研究赞助商(除了成员的临时数据分析和主要终点分析监控团队)仍然掩盖整个研究治疗任务。主要终点是患者的比例达到50%或更高的改进从基线F-VASI (F-VASI50)在24周,意向处理人口的评估。这项研究是在ClinicalTrials.gov注册,NCT03099304。 FINDINGS: Between June 7, 2017, and March 21, 2018, 205 patients were screened for eligibility, 48 were excluded and 157 patients (mean age, 48.3 years [SD 12.9]; 73 [46%] male and 84 [54%] female) were randomly assigned to either an intervention group or the control group. 32 (20%) of 157 were assigned to the control group, 31 (20%) to the 0.15% once daily group, 31 (20%) to the 0.5% once daily group, 30 (19%) to the 1.5% once daily group, and 33 (21%) to the 1.5% twice daily group. F-VASI50 at week 24 was reached by significantly more patients given ruxolitinib cream at 1.5% twice daily (15 [45%] of 33) and 1.5% once daily (15 [50%] of 30) than were treated with vehicle (one [3%] of 32). Four patients had serious treatment-emergent adverse events (one patient in the 1.5% twice daily group developed subdural haematoma; one patient in the 1.5% once daily group had a seizure; one patient in the 0.5% once daily group had coronary artery occlusion; and one patient in the 0.5% once daily group had oesophageal achalasia), all of which were unrelated to study treatment. Application site pruritus was the most common treatment-related adverse event among patients given ruxolitinib cream (one [3%] of 33 in the 1.5% twice daily group; three [10%] of 30 in the 1.5% once daily group; three [10%] of 31 in the 0.5% once daily group; and six [19%] of 31 in the 0.15% once daily group)with three [9%] of 32 patients showing application site pruritis in the control group. Acne was noted as a treatment-related adverse event in 13 (10%) of 125 patients who received ruxolitinib cream and one (3%) of 32 patients who received vehicle cream. All treatment-related adverse events were mild or moderate in severity and similar across treatment groups. INTERPRETATION: Treatment with ruxolitinib cream was associated with substantial repigmentation of vitiligo lesions up to 52 weeks of treatment, and all doses were well tolerated. These data suggest that ruxolitinib cream might be an effective treatment option for patients with vitiligo. FUNDING: Incyte.

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