鲁索替尼 (ruxolitinib)/JAK抑制剂在局部白癜风治疗中的临床数据！
这是一篇关于鲁索利替尼 (ruxolitinib)/JAK抑制剂在局部白癜风治疗中的研究数据。这篇文章是我从外网看到的，来自于：medical news/Medpage today，扒下来跟大家分享一下。不保证他的数据准确性！不保证翻译准确性！
题目： Topical JAK Inhibitor Shows Promise in Vitiligo-- Half of patients had 90% improvement after 2 years of treatementBy Charles Bankhead题目： JAK抑制剂在局部白癜风治疗中的应用前景 -经过两年的治疗，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，半数白癜风患者面部色素沉着改善了90%，超过四分之一的白癜风患者经局部鲁克索利替尼(Jakafi)长期治疗后，全身色素沉着率提高了75%。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%的患者面部白癜风至少有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 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周的治疗，鲁克索利替尼霜治疗白癜风病变，产生了大量的面部和全身色素沉着。”较长的治疗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，没有任何与治疗相关的严重不良事件的报道。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，阿霉素和光疗治疗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.白癜风是一种慢性自身免疫性疾病，其发病机制以干扰素-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。哈里斯和他的同事报告了第104周的后续调查结果。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，白癜风的实验治疗，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患者也是如此。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-label treatment.完成52周治疗的患者可以选择继续使用1.5%的鲁索利替尼进行开放标签治疗，为期104周(总共156周的随访)。在开放的治疗过程中，患者可以选择同时使用nbUVB.Vitiligo status was assessed by the facial (F) and total (T) Vitiligo Area Scoring Index (F or T-VASI) for improvement of ≥50% (VASI50), ≥75% (VASI75), and ≥90% (VASI90). Response was also assessed by the Physician's Global Vitiligo Assessment (PhGVA), with response defined as clear or almost clear skin. Patients rated their treatment outcome by means of the Patient Global Impression for Vitiligo (PaGIC-V), with response defined as very much or much improved.用面部(F)和总(T)白癜风面积评分指数(F或T-VASI)评定白癜风状态，以改善≥50%(VASI 50)、≥75%(VASI 75)和≥90%(VASI 90)。医生的全球白癜风评估(PhGVA)也对反应进行了评估，反应被定义为皮肤干净或几乎干净。植患泰者肤通色过纹患色者遮对盖白癜风的整体印象(PaGIC-V)来评估他们的治疗结果，其反应被定义为非常或有很大的改善。The report by Harris and colleagues focused on 55 patients who completed 104 weeks of treatment. The results showed that 38 of 94 patients (40.4%) had F-VASI50 responses at 24 weeks, increasing to 50.0% at 52 weeks, and 83.6% (46 of 55) at 104 weeks.哈里斯和他的同事的报告重点关注了完成104周治疗的55名患者。结果显示，94例患者中，38例(40.4%)24周出现F-VASI 50反应，52周时为50.0%，104周时为83.6%(46/55)。F-VASI75 response rates increased from 21.3% at 24 weeks to 37.2% at 52 weeks, and 65.5% at 104 weeks. The F-VASI90 response at 104 weeks was 52.7% as compared with 11.7% at 24 weeks.F-VASI 75的应答率从24周的21.3%上升到52周的37.2%，104周时提高到65.5%。104周时F-VASI 90有效率为52.7%，24周时为11.7%.T-VASI response rates also improved over time. T-VASI50 response increased 13.8% at 24 weeks to 30.9% at 52 weeks to 58.2% at 104 weeks. Corresponding values for T-VASI75 were 2.1%, 9.6%, and 27.3%. F-PhGVA response was 10.6% at 24 weeks, increasing to 21.5% at 52 weeks and 43.6% at 104 weeks. PaGIC-V responses stood at 26.4% at 24 weeks and increased to 42.3% at 52 weeks and 55.6% at 104 weeks.随着时间的推移，T-VASI的应答率也有所提高.T-VASI 50反应24周增加13.8%，52周增加30.9%，104周增加58.2%。T-VASI 75的相应值分别为2.1%、9.6%和27.3%.FPhGVA反应24周时为10.6%，52周时为21.5%，104周时为43.6%.PAGIC-V反应在24周时为26.4%，52周时为42.3%，104周时为55.6%。Patients initially randomized to ruxolitinib 1.5% BID and who continued treatment to 104 weeks had similar progressive improvement, Harris and co-authors reported. F-VASI50, 75, and 90 responses at 104 weeks were 89.5%, 73.7%, and 57.9%. The T-VASI50 response rate was 63.2%, and 26.3% of patients had T-VASI75 responses.哈里斯和他的合著者报告说，最初随机使用鲁索立替尼1.5%Bid并持续治疗104周的患者也有类似的进步。104周时F-VASI 50、75和90的应答率分别为89.5%、73.7%和57.9%.T-VASI 50有效率为63.2%，26.3%有T-VASI 75反应.The most common treatment-emergent adverse events (all grades) during the open-label phase were sinusitis (5.2%), nasopharyngitis (3.9%), upper respiratory tract infection (3.9%), and oral herpes (3.9%).最常见的急诊不良事件(所有级别)是鼻窦炎(5.2%)、鼻咽炎(3.9%)、上呼吸道感染(3.9%)和口腔疱疹(3.9%)。The analysis of nbUVB add-on therapy during open-label treatment with 1.5% ruxolitinib included 19 patients, as reported by Amit G. Pandya, MD, of Palo Alto Foundation Medical Group in California and the UT Southwestern Medical Center in Dallas, and coinvestigators.NbUVB加用1.5%鲁索利替尼在开放标签治疗中的分析包括19名患者，由加州Palo Alto基金会医疗集团和达拉斯UT西南医疗中心的Amit G.Pandya博士报告。F-VASI50 responses increased from 68% at 52 weeks to 89% at 104 weeks. F-VASI75 responses increased from 42% to 68% and F-VASI90 responses from 21% to 58%. T-VASI50 response rates were 42% at 52 weeks and 68% at 104 weeks, and the proportion of patients with T-VASI75 responses increased from 0% to 32%.F-VASI 50反应从52周时的68%上升到104周时的89%.F-VASI 75反应从42%增加到68%，F-VASI 90反应从21%上升到58%。52周时T-VASI 50有效率为42%，104周时为68%，T-VASI 75应答率由0%增至32%。In a small subgroup of patients who did not achieve F-VASI50 responses at 24 weeks, similar improvement from 52 to 104 weeks was observed with the add-on phototherapy.在一小部分在24周没有达到F-VASI 50反应的患者中，加用光疗也观察到了类似的改善，从52周到104周。JAK inhibitors are not FDA approved for vitiligo and continue to be evaluated in clinical trial settings. Additionally, the topical formulation used in the studies has to be prepared at a compounding pharmacy, said vitiligo specialist Seemal Desai, MD, of Innovative Dermatology in Plano, Texas, and UT Southwestern Medical Center.Jak抑制剂未经FDA批准用于白癜风，并继续在临床试验中进行评估。此外，白癜风专家说，研究中使用的外用制剂必须在一家综合性药房中配制。赛马尔德赛（Seemal Desai)，位于德克萨斯州普莱诺市和UT西南医学中心的创新型皮肤科。"We need more data, but at this point, they are promising," he told MedPage Today. "I typically reserve the treatment for smaller body surface areas because the product is expensive. If you try to use it on someone who has vitiligo all over their body, it becomes cost prohibitive.“我们需要更多的数据，但到目前为止，它们(JAK抑制剂)是有希望的，”他对记者说。“我通常会为较小的体表面积保留治疗，因为这种产品很昂贵。如果你试图将它用于全身有白癜风的人，就会导致成本过高。”"That said, I find it very helpful. I have combined it with UV light, and we now have data to show that these agents have a kind of synergistic effect with UV light. That doesn't mean the products don't work on their own, but we think that UV light may actually make them work better."“尽管如此，我觉得这很有帮助。我把它和紫外光结合在一起，我们现在有数据显示，这些药剂与紫外线有某种协同作用。这并不意味着产品本身就不能工作，但我们认为紫外光实际上可能会让它们工作得更好。”More than one JAK inhibitor is being evaluated in vitiligo. Different drugs target different components of the JAK signaling pathway, and more studies are needed to determine how to make optimal use of the topical products, said Desai.一个以上的JAK抑制剂正在评估白癜风。Desai说，不同的药物针对JAK信号通路的不同成分，需要更多的研究来确定如何最佳地利用这些外用产品。"I think the future of this is very bright," he added. "Topical JAK inhibitors are being looked at in other inflammatory skin diseases, like alopecia areata, atopic dermatitis, and psoriasis. The more we learn about these products, the more exciting the work becomes because we're really getting to see they have a broad (clinical) area and a broad scope."“在其他炎症性皮肤病(如斑秃、特应性皮炎和银屑病)中，局部JAK抑制剂正在被研究。我们对这些产品了解得越多，工作就越令人兴奋，因为我们真正看到它们具有广泛的(临床)领域和广阔的范围。”真心祝你们早日康复！
这个药怎么能买到
初六 发表于 2021-9-25 13:15 static/image/common/back.gif
这个药怎么能买到
快了
什么时候上市
tianyuetuzi 发表于 2021-9-25 15:40
什么时候上市
鲁索利替尼 (ruxolitinib)/JAK抑制剂的价格为1950美元每支，10月上市 植泰肤色 发表于 2021-9-25 18:20 static/image/common/back.gif
鲁索利替尼 (ruxolitinib)/JAK抑制剂的价格为1950美元每支，10月上市
真这么贵吗
德艺双馨 发表于 2021-9-25 18:30
真这么贵吗
我从外网上看到的帖子，不确定信息的真实性 有点贵，而且不好买，处方药医生应该需要见本人 71315 发表于 2021-9-26 21:07
有点贵，而且不好买，处方药医生应该需要见本人
如果真的有效 上有政策 下有对策
页:
[1]