EN
登录

美国食品药品监督管理局批准治疗持续性湿疹的新方法

FDA Approves New Treatment for Persistent Eczema

WebMD 等信源发布 2024-09-17 00:30

可切换为仅中文


Sept. 17, 2024 – The FDA has approved a new treatment for persistent eczema called Ebglyss that eventually only needs to be taken once per month, offering a less frequent maintenance dose schedule than alternatives.Ebglyss is approved for people age 12 and older with moderate to severe atopic dermatitis, which is the most common type of eczema.

2024年9月17日,美国食品和药物管理局(FDA)批准了一种新的治疗持续性湿疹的方法,称为Ebglyss,最终只需要每月服用一次,其维持剂量表的频率低于替代品。Ebglyss被批准用于12岁及以上的中度至重度特应性皮炎患者,这是最常见的湿疹类型。

Ebglyss may be used when symptoms like dull to bright redness and rough skin patches, possibly with oozing and crusting, remain even after treatment with topical options like creams and ointments, according to the FDA.The medicine is a monoclonal antibody given by injection using a prefilled pen every 2 weeks at first but may be taken just once per month as a maintenance dose.

美国食品和药物管理局(FDA)表示,即使在使用面霜和软膏等局部选择治疗后,如果症状仍然存在,如暗红色至亮红色和粗糙的皮肤斑块,可能伴有渗出和结痂,也可以使用Ebglyss。这种药物是一种单克隆抗体,最初每两周用预填充笔注射一次,但作为维持剂量,可能每月只服用一次。

Alternative treatments typically involve daily pills or twice-monthly injections.“Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,' said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences, in a statement from drugmaker Eli Lilly.

替代疗法通常包括每日服用药片或每月两次注射。乔治华盛顿大学医学与健康科学学院皮肤病学副教授乔纳森·西尔弗伯格(JonathanSilverberg)在制药商礼来(Eli Lilly)的一份声明中说:“患者仍然难以用现有的治疗方法控制中度至重度特应性皮炎。许多患者的长期疾病控制不佳,严重的瘙痒会严重影响他们的日常生活。”。

Silverberg worked on two studies of the medicine.In clinical trials, 38% of people who took Ebglyss (generic name: lebrikizumab-lbkz) had clear or almost clear skin after 4 months, compared to 12% of people who took a placebo and reported similar results, according to a summary from Eli Lilly. Itch relief was among the top outcomes. For people who got results from the treatment, 77% maintained clear or almost clear skin after switching to once-per-month treatments for the remainder of the year.

西尔弗伯格从事了两项医学研究。根据礼来公司的一份总结,在临床试验中,服用Ebglyss(通用名:lebrikizumab lbkz)的人中有38%在4个月后皮肤清澈或几乎清澈,而服用安慰剂并报告类似结果的人中有12%。瘙痒缓解是最重要的结果之一。对于从治疗中获得结果的人来说,77%的人在今年剩下的时间里改用每月一次的治疗后,皮肤保持清澈或几乎清澈。

Study results also showed that some people could stop taking Ebglyss after 4 mon.

研究结果还表明,一些人可以在4个月后停止服用Ebglyss。