Ligelizumab自发为慢性荨麻疹。
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毛雷尔M, Gimenez-Arnau,苏斯曼G,梅斯M,贝克博士,鲍尔,伯恩斯坦是的,Brehler R,楚CY,钟WH, Danilycheva我,赫伯特J,格拉特C Katelaris C, Makris M, Meshkova R,萨维奇,辛克莱R,坐K, Staubach P, B Wedi Loffler J,勇敢,小林K,华E,雪华铃T, Janocha R
Ligelizumab自发为慢性荨麻疹。
郑传经地中海J。2019年10月3;381 (14):1321 - 1332。doi: 10.1056 / NEJMoa1900408。
- PubMed ID
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31577874 (在PubMed]
- 文摘
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背景:大多数患者自发慢性荨麻疹,大多数目前治疗不完整导致症状控制。Ligelizumab是新一代的高亲和性人性化单克隆ige抗体。数据是有限的剂量反应关系ligelizumab ligelizumab的疗效和安全性比omalizumab自发和安慰剂的患者有严重慢性荨麻疹与H1-antihistamines不足控制在批准或增加剂量,单独或结合H2-antihistamines或leukotriene-receptor拮抗剂。方法:在2 b期药物剂量摸索试验中,我们随机分配病人接受的剂量ligelizumab 24毫克,72毫克,或240毫克,omalizumab 300毫克的剂量,或安慰剂,每4周皮下接种一段20周,或一个120毫克剂量的ligelizumab。疾病症状的荨麻疹、瘙痒和血管性水肿是监控通过每周活动的成绩。的主要目标是确定剂量反应关系的完全控制蜂巢(由每周hives-severity得分为0,表示在一个范围从0到21日,得分越高表示更大的严重程度);这个响应的主要终点是在第12周的评估。完整的症状控制被每周荨麻疹表示活动得分为0(规模从0到42岁,得分越高表示更大的严重性)。安全在整个试验进行了分析。结果:共有382名患者进行了随机化。 At week 12, a total of 30%, 51%, and 42% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of hives, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. A dose-response relationship was established. At week 12, a total of 30%, 44%, and 40% of the patients treated with 24 mg, 72 mg, and 240 mg, respectively, of ligelizumab had complete control of symptoms, as compared with 26% of the patients in the omalizumab group and no patients in the placebo group. In this small and short trial, no safety concerns regarding ligelizumab or omalizumab emerged. CONCLUSIONS: A higher percentage of patients had complete control of symptoms of chronic spontaneous urticaria with ligelizumab therapy of 72 mg or 240 mg than with omalizumab or placebo. (Funded by Novartis Pharma; ClinicalTrials.gov number, NCT02477332.).
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