就在2021年12月14日，美国食品药品监督管理局（FDA）已经接受局部JAK抑制剂Opzelura (ruxolitinib,芦可替尼乳膏1.5%）的补充新药申请（sNDA）进行优先审查，作为青少年和成人(年龄≥12岁)白白的潜在冶辽方法。FDA授予优先审查可能在冶辽方面提供重大进展的药物，而目前还没有这种药物。两个月前，我在外网上看到了一篇关于鲁索利替尼 (ruxolitinib)/JAK抑制剂在局部白白冶辽中的研究数据。(来自于：medical news/Medpage today) , 扒下来跟大家分享一下。 原文章最早发布在我的另外那个号里。

不保证文章数据准确性！不保证文章翻译准确性！白癜风肤色纹身遮盖

题目： Topical JAK Inhibitor Shows Promise in Vitiligo

-- Half of patients had 90% improvement after 2 years of treatement

By Charles Bankhead

题目： JAK抑制剂在局部白白冶辽中的应用前景白癜风纹肤色

-经过两年的冶辽，有一半的患者得到了90%的改善

Half of patients with vitiligo achieved 90% improvement in facial repigmentation and more than a fourth had 75% improvement in total body repigmentation after long-term treatment with topical ruxolitinib (Jakafi), a randomized controlled study showed.

一项随机对照研究显示，半数白白朋友面部色素沉着改善了90%，超过四分之一的白白朋友经局部鲁克索利替尼(Jakafi)长期冶辽后，全身色素沉着率提高了75%。白癜风人工肤色修复

Measurable improvement occurred within 24 weeks and progressively increased during follow-up to 52 and 104 weeks. At the 104-week assessment, 83.6% of patients had at least 50% improvement in facial vitiligo, including 52% who had 90% improvement. With respect to total-body involvement, 58.2% of patients had at least 50% improvement at 104 weeks and 27.3% had 90% improvement.

可测量的改善发生在24周内，并在随访期间逐渐增加到52周和104周。在104周的评估中，83.6%的患者面部白白至少有50%的改善，其中52%的患者有90%的改善。在全身受累方面，58.2%的患者在104周时至少有50%的改善，27.3%的患者有90%的改善。

Additionally, 43.6% of the patients' physicians rated facial skin status as clear or almost clear, and a majority of patients said their condition was very much or much improved, as reported during the American Academy of Dermatology virtual meeting.

此外，43.6%的患者医生将面部皮肤状况评定为清楚或几乎清楚，大多数患者说他们的状况有了很大的改善，在美国皮肤病学会线上会议中报告。

"Treatment with ruxolitinib cream produced substantial facial and total body repigmentation of vitiligo lesions through 104 weeks of treatment," concluded John E. Harris, MD, PhD, of the University of Massachusetts Medical School in Worcester, and coinvestigators, in a poster presentation. "Longer duration of therapy was associated with greater repigmentation ... at weeks 24, 52, and 104. Ruxolitinib cream was well tolerated over a 2-year period, and no treatment-related serious AEs [adverse events] were reported."

伍斯特马萨诸塞大学医学院的约翰·E·哈里斯(John E.Harris)博士在海报展示中总结说：“通过104周的冶辽，鲁克索利替尼霜冶辽白白病变，产生了大量的面部和全身色素沉着。”较长的冶辽时间与更严重的色素沉着有关.在24、52和104周。鲁克索利替尼乳膏在2年内耐受性很好，没有任何与冶辽相关的严重不良事件的报道。植泰肤色纹色遮盖

A separate analysis of patients treated with topical ruxolitinib and phototherapy showed even greater improvement with the addition of narrow-band ultraviolet-B (nbUVB) from weeks 52 to 104.

一项单独的分析表明，在52至104周的窄带紫外线B(NbUVB)的加入，阿霉素和光疗冶辽的患者得到了更大的改善。

Vitiligo is a chronic autoimmune disease, with pathogenesis driven by interferon-gamma, which leads to activation of signaling pathways regulated by Janus kinase (JAK) 1 and 2. In a phase II randomized dose-finding study, a topical formulation of ruxolitinib, a JAK1/2 inhibitor, produced significant repigmentation over 52 weeks. Zhi Tai Harris and colleagues reported findings from continued follow-up to week 104.

白白是一种慢性自身免疫性疾bing，其发bing机制以干扰素-γ为主导，激活了由Janus激酶(Jak)1和2调控的信号通路。第二阶段随机剂量发现研究，一种JAK 1/2抑制剂Ruxolitinib的局部配方，在52周内产生明显的色素沉着。哈里斯和植泰的同事报告了第104周的后续调查纹色结果。

Patients eligible for the study had depigmentation of at least 0.5% of body surface area on the face and at least 3% on nonfacial areas. Key exclusions included confounding dermatologic conditions, prior JAK inhibitor exposure, and use of biologics, experimental therapy for vitiligo, phototherapy, or immunomodulating agents.

符合研究条件的患者在面部至少有0.5%的体表面积和至少3%的非面部区域。主要排除包括混淆皮肤病，先前的JAK抑制剂暴露，生物制剂的使用，白白的实验冶辽，光疗，或免疫调节剂。

Patients were randomized to four concentrations of ruxolitinib cream or cream vehicle, applied once or twice daily. At 24 weeks, patients in the vehicle arm were re-randomized to one of the three higher doses of ruxolitinib, as were patients who did not have at least 25% improvement with the lowest ruxolitinib concentration. The remaining patients continued treatment with their original ruxolitinib doses to week 52.

患者被随机分为四种浓度的鲁索利替尼乳膏或乳膏载体，每日一次或两次。24周时，车辆臂上的病人被重新随机分为三种高剂量的鲁索利替尼(Ruxolitinib)中的一种，而那些没有得到至少25%改善和最低鲁索利替尼浓度的huan者也是如此。其余的病人继续使用他们原来剂量的鲁克索利替尼治疗到52周。

Patients who completed 52 weeks of treatment had the option to continue open-label treatment with 1.5% ruxolitinib for an additional 104 weeks (156 weeks total follow-up). Optionally, patients could choose to have concomitant nbUVB during open-labeltreatment.