Povorcitinib治疗非节段型白癜风：两项随机、对照、3期STOP-V试验。
完整摘要 · 中文译文
对于适合接受系统性治疗的非节段性白癜风（NSV）患者，仍存在未被满足的复色治疗需求。本文报告了两项平行、3期、随机、双盲、安慰剂对照试验的52周主要结果，这两项试验评估每日一次povorcitinib（口服、高选择性JAK1抑制剂）30 mg用于中度至重度NSV成人患者（STOP-V1和STOP-V2）。STOP-V1和STOP-V2分别入组467例和449例患者。在这两项研究中，均达到了第52周面部白癜风面积评分指数改善≥75%（F-VASI75）的主要终点，显示与安慰剂相比，povorcitinib具有统计学显著且临床意义的复色作用（STOP-V1：18.9%对6.8%；比值比3.1；95%置信区间1.6-5.9；P = 0.0003；STOP-V2：18.9%对3.1%；比值比7.5；95%置信区间3.0-18.6；P < 0.0001）。povorcitinib耐受性良好；两项研究中povorcitinib组与安慰剂组发生任何治疗中出现的不良事件（TEAE）的患者百分比相似（STOP-V1/STOP-V2，68.7%/66.7%对63.7%/62.7%）。povorcitinib最常见的TEAE为鼻咽炎（STOP-V1/STOP-V2，11.2%/11.3%对安慰剂9.8%/11.1%）、痤疮（10.7%/10.8%对3.0%/2.2%）和上呼吸道感染（6.9%/14.0%对9.0%/10.7%）。严重TEAE通常为单一事件，Janus激酶抑制剂类药物特异性TEAE未出现或罕见。这些结果支持每日一次povorcitinib作为中度至重度NSV成人患者有效且耐受性良好的系统性治疗。C ClinicalTrials.gov 标识符：NCT06113445、NCT06113471。
完整摘要 · 英文原文
There is an unmet need for repigmentation therapies for patients with nonsegmental vitiligo (NSV) who are candidates for systemic therapy. Here, 52-week primary results are reported from two parallel phase 3, randomized, double-blind, placebo-controlled trials of once-daily povorcitinib (oral, highly selective JAK1 inhibitor) 30 mg in adults with moderate-to-severe NSV (STOP-V1 and STOP-V2). STOP-V1 and STOP-V2 enrolled 467 and 449 patients, respectively. In both studies, the primary endpoint of ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) at week 52 was met, demonstrating statistically significant and clinically meaningful repigmentation with povorcitinib versus placebo (STOP-V1: 18.9% versus 6.8%; odds ratio, 3.1; 95% confidence interval 1.6-5.9; P = 0.0003; STOP-V2: 18.9% versus 3.1%; odds ratio, 7.5; 95% confidence interval 3.0-18.6; P < 0.0001). Povorcitinib was well tolerated; the percentage of patients with any treatment-emergent adverse event (TEAE) was similar between the povorcitinib and placebo groups in both studies (STOP-V1/STOP-V2, 68.7%/66.7% versus 63.7%/62.7%). The most common TEAEs with povorcitinib were nasopharyngitis (STOP-V1/STOP-V2, 11.2%/11.3% versus placebo, 9.8%/11.1%), acne (10.7%/10.8% versus 3.0%/2.2%) and upper respiratory tract infection (6.9%/14.0% versus 9.0%/10.7%). Serious TEAEs were generally single events, and Janus kinase inhibitor class-specific TEAEs were absent or rare. These results support once-daily povorcitinib as an effective and well-tolerated systemic treatment for adults with moderate-to-severe NSV. ClinicalTrials.gov identifiers: NCT06113445 , NCT06113471 .