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Interim Results: Inycte Clinical Trial For Topical Ruxolitinib
Hi everyone, I promised to use this newsletter to keep everyone up to date about cutting-edge developments in vitiligo, and it’s time to let you in on some breaking news! Minutes ago, we announced the interim results from the Inycte clinical trial for topical ruxolitinib, which was the first large, randomized clinical trial to test a treatment for vitiligo. The presentation was at the World Congress of Dermatology in Milan, Italy and it generated lots of interest in the crowd.
For some background, we and a few others reported that the JAK inhibitors tofacitinib and ruxolitinib were effective treatments in a small number of patients with vitiligo. The rationale for using these treatments was based on the cytokine signaling pathways resp**ible for driving vitiligo, which you can read more about in detail here:
https://go.umassmed.edu/e/184882/go-research-adaptive-immunity-/2lj9nrj/2191094899?h=zEsI4dyx0pQ0ShDQ9rq4WGavCJFryYu7uR-NqS2lPYY
These inhibitors were used both orally and topically in a few patients, and Incyte was the first company to initiate a clinical trial in vitiligo to test these treatments formally. As a quick reminder, here is the blog post I wrote in the summer of 2017 announcing the study:
https://go.umassmed.edu/e/184882/effective-for-facial-vitiligo-/2lj9nrl/2191094899?h=zEsI4dyx0pQ0ShDQ9rq4WGavCJFryYu7uR-NqS2lPYY
The trial was started in the spring of 2017 and recruited 157 participants, completing enrollment for the study in the fall of 2018. During the first 6 months, participants were randomized to placebo or 4 different treatment doses of the drug. For the next 6 months, those who were initially randomized to placebo were re-randomized to one of the higher doses of the drug. For the following year, all participants were given the highest dose of the drug and allowed to use phototherapy if they wanted.
At the meeting in Milan on Saturday morning, we reported the results from the first 6 months of treatment, and they were outstanding! 139 out of 157 participants completed this portion of the study, and these included an equal representation of men and women, with a mean age of 48 years old. Participants were well represented from the medium skin tones, but those with very light skin and very dark skin were under-represented. The company wants to improve the representation in these categories in future studies. Most subjects had been on some prior treatment without satisfactory results.
Within 8 weeks, participants randomized to the treatment were already seeing significant improvement, particularly on the face (and some just after 4 weeks). There was clear separation from placebo by 12 weeks. By the end of the 6-month period, 50% of subjects on the 2 highest doses of treatment had achieved a F-VASI-50, meaning they had 50% of the pigment back in their spots on their face, and this was expected to continue with further treatment. Just over 30% of participants on the highest dose had even achieved a F-VASI-75, meaning they had at least 75% of their pigment back on their face in 6 months, which is fast. The placebo resp**e was very low, with only 3% achieving an F-VASI-50, and nobody achieving F-VASI-75. While not reported in the short presentation, subjects saw improvement on non-facial areas of their body as well. Side effects of using the medication c**isted primarily of increased acne in 10-15% of participants, while other reported side effects were not more common in patients using the drug compared to those using the placebo, and very few discontinued the treatment because of any side effects.
These results are really good, and we fully expect that the 1-year results will be even better, since the trajectory of improvement was still increasing at the 6-month time point. Because of these promising results, there is word that Incyte is strongly c**idering a worldwide Phase III study for this drug, which would allow them to seek FDA-approval to market the drug for vitiligo patients. If this happens, it would be the first FDA-approved medical treatment to reverse vitiligo. Keep your eyes open for more results and announcements, this is only the beginning!
We will soon be announcing a new clinical trial that we will start at UMass and other sites around the world. Expect a newsletter VERY soon with this information.
If you interested in reading the presentation from the World Congress of Dermatology in Milan, Italy, you can download it here.
Sincerely,
Dr. John E. Harris
翻译如下：
中期结果:局部应用鲁索利替尼的Inycte临床试验
大家好，我答应过用这个通讯来让大家了解白癜风的最新进展，是时候让你了解一些突发新闻了!几分钟前，我们宣布了Inycte局部应用鲁索利替尼临床试验的中期结果，这是第一个测试白癜风治疗的大型随机临床试验。这次演讲是在意大利米兰举行的世界皮肤病学大会上进行的，引起了很多人的兴趣。
由于一些背景，我们和其他一些人报道了JAK抑制剂tofacitinib和ruxolitinib是少数白癜风患者的有效治疗。使用这些疗法的理由是基于细胞因子信号通路，而细胞因子信号通路是导致白癜风的原因。
https://go.umassmed.edu/e/184882/go-research-adaptive-immunity-/2lj9nrj/2191094899?h=zEsI4dyx0pQ0ShDQ9rq4WGavCJFryYu7uR-NqS2lPYY
这些抑制剂在少数患者中同时口服和局部使用，Incyte是第一个正式启动白癜风临床试验的公司。提醒一下，我在2017年夏天写的一篇博文宣布了这项研究:
https://go.umassmed.edu/e/184882/effective-for-facial-vitiligo-/2lj9nrl/2191094899?h=zEsI4dyx0pQ0ShDQ9rq4WGavCJFryYu7uR-NqS2lPYY
该试验于2017年春季开始，招募了157名参与者，并于2018年秋季完成了该研究的注册。在前6个月，参与者被随机分配到安慰剂组或4种不同剂量的药物治疗组。在接下来的6个月里，那些最初被随机分配到安慰剂组的人被重新随机分配到更高剂量的药物组。在接下来的一年里，所有的参与者都被给予了最高剂量的药物，如果他们愿意，还可以使用光疗。
在周六上午米兰的会议上，我们报告了治疗前6个月的结果，他们非常出色!157名参与者中有139人完成了这项研究的这一部分，其中男性和女性的比例相等，平均年龄为48岁。中等肤色的参与者有很好的代表性，但是那些肤色很浅和很黑的参与者没有很好的代表性。公司希望在未来的研究中提高这些类别的代表性。大多数受试者曾接受过一些先前的治疗，但没有得到满意的结果。
在8周内，随机分配到治疗组的参与者已经看到了明显的改善，尤其是面部(有些在4周后)。安慰剂与安慰剂在12周后明显分离。在6个月的试验结束时，接受两种最高剂量治疗的受试者中有50%的人达到了f - vasi50，这意味着他们脸上的斑点中有50%的色素残留在脸上，这一情况有望在进一步的治疗中继续下去。在服用最高剂量的受试者中，超过30%的人甚至达到了f - vsi -75，这意味着他们在6个月内至少有75%的色素回到了脸上，这是很快的。安慰剂反应非常低，只有3%的人达到f - vasi50，没有人达到f - vasi75。虽然在简短的陈述中没有报告，但受试者也发现他们身体的非面部区域有所改善。使用该药物的副作用主要包括10-15%的参与者痤疮增加，而其他报道的副作用在使用该药物的患者中并不比使用安慰剂的患者更常见，而且很少有人因为任何副作用而停止治疗。
这些结果非常好，我们完全预计1年的结果会更好，因为在6个月的时间点，改善的轨迹仍然在增加。由于这些有希望的结果，有消息称，Incyte正强烈考虑在全球范围内对这种药物进行III期研究，这将使他们能够寻求fda的批准，为白癜风患者销售这种药物。如果发生这种情况，这将是fda批准的第一个治疗逆转白癜风的药物。关注更多的结果和公告，这只是开始!
我们将很快宣布一项新的临床试验，我们将开始在马萨诸塞州立大学和世界各地的其他地点。期待与此信息通讯很快。
如果你有兴趣阅读意大利米兰世界皮肤病学大会的演示文稿，可以在这里下载。
真诚地,
约翰·e·哈里斯博士
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发表于 2019-6-15 17:12:35
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