课程介绍
我是 Linda Stein Gold 医生,同时担任皮肤病学临床研究部主任,任职于美国密歇根州底特律市的亨利・福特医疗体系。
欧洲皮肤病与性病学会(EADV)年会此次行程非常紧凑,期间安排了大量活动,我在会上分享了多个不同主题的内容。我们展示了几张海报,其中一张聚焦于乌帕替尼(Upadacitinib)在中重度特应性皮炎患者中的应用,并提出了相关问题:这类患者的情况如何?存在哪些风险?尤其是正在服用口服避孕药的患者,其真实风险究竟如何?我们重点关注了主要不良心血管事件及恶性肿瘤的发生风险,研究结果显示:对于年轻患者乃至中年患者,即便长期使用该药物,这类风险实际上也非常低。目前我们已获得针对特应性皮炎患者长达 7 年的安全性数据,且尚未发现明确的安全性风险信号,这无疑是个好消息。我还重点介绍了一种新药德戈替尼(Delgocitinib),该药物近期已获得美国食品药品监督管理局(FDA)批准在美国上市,它是一种非选择性 JAK 抑制剂,以外用乳膏形式存在,刚获得 FDA 批准适用于所有类型的慢性手部湿疹,包括特应性慢性手部湿疹、刺激性慢性手部湿疹和过敏性慢性手部湿疹。该药物通过每日两次外用,能够有效控制患者病情,并实现长期病情稳定,且具有良好的耐受性与安全性。最后,我还介绍了一种处于研究阶段的新型银屑病口服药物 —— 伊科托金拉(Icotrokinra),它是一种口服肽类药物,作用靶点为白细胞介素 - 23(IL-23)受体,可阻断 IL-23 的下游信号传导。我在会上展示了一项研究,该研究将这种药物与氘可来昔替尼(一种酪氨酸激酶 2 抑制剂)以及安慰剂进行直接疗效对比,结果显示,伊科托金拉的疗效显著更优,不仅优于安慰剂,也优于氘可来昔替尼 —— 即便在达成 “让患者银屑病完全清除” 这类高难度治疗目标时也是如此。事实上,这种新型口服肽类药物在实现患者皮损 “清除” 或 “接近清除” 方面,疗效是氘可来昔替尼的两倍;在安全性方面,其安全性特征与安慰剂相当。
总而言之,此次会议内容丰富,能参与其中我感到非常振奋,也期待未来能参加更多此类学术会议。
My name is Dr. Linda Stein Gold, and I'm the Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan in the United States.
The EADV has been a very busy conference, a lot of things going on, and I presented several different subjects. There were a few posters; one looked at Upadacitinib in patients with moderate to severe atopic dermatitis, and we asked the questions: what about those patients? What are the risks? Specifically, what are the true risks of patients who are on oral contraceptives? We focused on major adverse cardiovascular events and malignancy, and what we found was: for younger patients and even middle-aged adults, the risk really seems to be quite minimal, even when using this drug over time. We have safety data for seven years in atopic dermatitis, and we're still not seeing a true safety signal, so that's good news. I spoke a lot about a new drug (Delgocitinib) that was recently FDA-approved in the United States—it's a pan-JAK inhibitor. It’s a topical cream that just got FDA approval for all different types of chronic hand eczema, including atopic chronic hand eczema, irritant chronic hand eczema, and allergic chronic hand eczema. When used twice daily, this drug showed it was able to get patients’ conditions under control and keep them under control for the long term, with a very good tolerability and safety outcome. And then finally, I talked about a new oral medication in studies for psoriasis—this drug (Icotrokinra) is an oral peptide that targets the IL-23 receptor and prevents the downstream signaling of IL-23. I presented a study where we compared this drug directly to Deucravacitinib (a TYK2 inhibitor) and placebo, and this drug (Icotrokinra) actually showed better efficacy than not only placebo but also Deucravacitinib—even in reaching high bars like getting patients completely clear of their psoriasis. In fact, the new oral peptide had double the efficacy of Deucravacitinib in terms of getting these patients to "clear" or "almost clear." In terms of safety, it had a safety profile similar to placebo.
So the bottom line is, there's so much going on at the conference; it's been so exciting to participate, and I'm looking forward to many more congresses.