Teprotumumab眼球运动眼病。

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史密斯TJ Kahaly GJ,以斯拉DG,弗莱明JC, Dailey RA,唐RA,哈里斯GJ,安东内利,Salvi M,戈德堡RA, Gigantelli JW,沙发SM,施赖弗EM,哈耶克BR, EM劳务,伍德沃德RM,加布里埃尔K,马尼G,道格拉斯RS

Teprotumumab眼球运动眼病。

郑传经地中海J。2017年5月4日,376 (18):1748 - 1761。doi: 10.1056 / NEJMoa1614949。

PubMed ID

28467880 (在PubMed

]

文摘

背景:眼球运动眼病,通常与坟墓有关的疾病,仍然是处理不当。当前医学疗法,它们主要包括糖皮质激素,有有限的疗效和安全问题。抑制的胰岛素样生长因子受体(IGF-IR)是一种新的治疗策略,以减弱底层自身免疫性眼病的发病机制。方法:我们进行了一项多中心、双盲、随机、安慰剂对照试验,以确定teprotumumab的疗效和安全性,人类单克隆抗体抑制剂IGF-IR,患者的活跃,是严重眼病。共有88名患者被随机分配接受安慰剂或活性药物静脉注射接种每隔3周总共八个输液。研究的主要终点是响应的眼睛。这种反应被定义为减少2点或更多的临床活动得分(分数范围从0到7分> / = 3表示活动眼球运动眼病)和减少2毫米或更多在24周的时候突出。次要终点,测量作为连续变量,包括突出,临床活动得分,结果坟墓的ophthalmopathy-specific生活质量调查问卷。不良事件进行评估。结果:意向处理人口,29岁的42个病人teprotumumab(69%),与9 45病人安慰剂相比(20%),有一个反应在24周(P < 0.001)。 Therapeutic effects were rapid; at week 6, a total of 18 of 42 patients in the teprotumumab group (43%) and 2 of 45 patients in the placebo group (4%) had a response (P<0.001). Differences between the groups increased at subsequent time points. The only drug-related adverse event was hyperglycemia in patients with diabetes; this event was controlled by adjusting medication for diabetes. CONCLUSIONS: In patients with active ophthalmopathy, teprotumumab was more effective than placebo in reducing proptosis and the Clinical Activity Score. (Funded by River Vision Development and others; ClinicalTrials.gov number, NCT01868997 .).

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药物

Teprotumumab