新型IL-17单抗Brodalumab（商品名：LUMICEF Subcutaneous Injection Syringe）是一种白细胞介素17(IL-17)受体的抑制剂，于2016年7月4日在日本批准上市，用于治疗寻常型银屑病、银屑病性关节炎、脓泡型银屑病和红皮症型银屑病。

ルミセフ皮下注210mgシリンジ

治疗类别名称
人抗IL-17受体的单克隆抗体制备
欧文商標名
LUMICEF Subcutaneous Injection 210mg Syringe
一般名
ブロダルマブ（遺伝子組換え）
Brodalumab (Genetical Recombination)
分子量
約147,000
本質
Burodarumabu是抗人白介素17受体A人IgG2单克隆抗体，在中国仓鼠卵巢细胞中产生。Burodarumabu是一个442氨基酸的H链（.gamma.2链）组成的氨基酸残基2和214个由氨基酸残基的L链（κ链）的2组成的糖蛋白。
操作注意事项
1.为了避免曝光，代理能够存储并把包装盒上。此外，外箱开口后也保存挡住光线。
2，包装打开之后立即使用
条件批准
对医药风险管理计划的发展，要正确实施。
药效药理
这种药物是针对人IL-17受体A（IL-17RA）的单克隆抗体，和选择性结合IL-17RA，IL-17A，IL-17F炎性细胞因子，IL-17A/ F异二聚体二聚体，通过IL-25（也称为IL-17E）和IL-17RA的IL-17C抑制信号转导。
(1) IL-17RA阻害作用
1）在体外试验中对人IL-17RA的高结合亲和力的人一定会竞争性的人IL-17RA和人IL-17A。
2）在体外研究，单核细胞的人淋巴细胞，粒细胞结合和各种人成纤维细胞，人IL-17A，IL-17F，IL-17A/ F异二聚体，IL-25和的细胞表面IL-它抑制由17C刺激诱导IL-17RA介导的生物活性。
(2) 针对牛皮癣的作用
1) 抗小鼠IL-17RA抗体，皮肤症状银屑病样通过腹膜内给药给小鼠银屑病模型（表皮增生，皮肤由于异常嗜中性细胞脓和角质形成细胞在皮肤层剥离）或病变它抑制了皮肤的各种炎症趋化因子和细胞因子mRNA的表达。
2) 本剂抑制IL-17A，IL-17F，IL-17C，IL-12B和IL-23A mRNA表达，角质形成细胞增殖和表皮增厚及炎性T细胞在银屑病患者的皮肤的损伤的表达（积累海外数据）。
(3) 对关节炎作用
抗小鼠IL-17RA抗体，并通过腹膜内给药给小鼠炎性关节炎模型（发红和肿胀）的关节炎病症的四肢，抑制骨破坏和关节软骨侵蚀与其相关联。
适应症
寻常型银屑病，关节病型银屑病，脓疱型银屑病，银屑病性红皮。
用法与用量
Lumicef®是一种皮下注射液，每只1.5mL注射器含210mg（brodalumab）。
推荐剂量为每周一次，每次210mg，首次于第0、1、2周给药，此后每2周一次。
包装规格
皮下注射：
210毫克注射器：1个注射器

制造厂商
协和发酵麒麟株式会社
原说明书资料附件：http://www.info.pmda.go.jp/go/pack/3999441G1029_1_02/
Announcement of Domestic Sales of Lumisep®for Psoriasis Treatment
Kyowa Hakko Kirin Co., Ltd. (Headquarters: Tokyo, President: Mr. Chen Yu Hui, hereinafter referred to as "Kyowa Hakko Kirin") has psoriasis vulgaris 1, arthropathic psoriasis 2, pustular psoriasis 3, psoriatic erythra We announce that we will begin selling "Lumisep® subcutaneous injection 210 mg syringe" (generic name: Brodarumab (Genetical recombination), hereinafter "Lumisep ®") with indication 4 as an indication on 30th September 2016. Lumisep ® is the first company in the world to be the first to sell in Japan.
Lumisep ® is a fully human antibody against interleukin (IL)-17 receptor A Note 5. This agent has a novel mechanism of action that inhibits the function of IL-17A, IL-17F, etc., 6 by specifically binding to IL-17 receptor A. It was approved in Japan on July 4, 2016, and was listed in the drug price standard on August 31 of the same year. This product is expected to improve the clinical symptoms and quality of life (quality of life) and the satisfaction level of treatment for diseased patients who have obtained approval.
The Kyowa Hakko Kirin Group pursues progress in life science and technology and contributes to the health and abundance of people around the world by creating new value.
. (Product information) Product name Lumisep®subcutaneous injection 210 mg syringe
Common name Brodalumab (Genetical recombination)
Indications/effects The following diseases that are ineffective in existing treatments
Psoriasis vulgaris, arthropathic psoriasis, pustular psoriasis, psoriatic erythroderma
Dosage and administration In general, adults receive 210 mg once as a brodullumab (genetical recombination) subcutaneously at an interval of 2 weeks after the first dose, 1 week and 2 weeks.
Packaging Lumisep®hypodermic injection 210mg syringe: 1 syringe
Approval acquisition date July 4, 2016
Drug price listing date August 31, 2016
Note 1 Psoriasis vulgaris
Psoriasis is a type of chronic skin disorder in which clear erythema with invasion/ thickening appears in the whole body and silvery white scales are observed. Approximately 90% of psoriasis is said to be plaque psoriasis.
2 Arthroscopic psoriasis
In addition to skin symptoms it calls for a disease type accompanied by the symptoms of arthritis. It is not necessarily correlated with the degree of skin rash, it may accompany strong joint swelling and pain. Although it shows symptoms similar to rheumatoid arthritis, rheumatoid reactions are not generally recognized in blood tests.
Note 3 Pustular psoriasis
With psoriasis, it is accompanied by fever and fatigue and calls for a disease type in which many pustules appear with redness on the skin of the whole body. It is severe in psoriasis and is life-threatening systemic inflammatory disease sometimes and it is designated as intractable disease in the country.
Note 4 Psoriatic erythroderma
It means that the rash of psoriasis spreads, spreads throughout the body and becomes red. Often accompanied by fever and malaise.
Note 5 IL-17 receptor A
It forms receptors for the inflammatory cytokines IL-17A, IL-17A/F, IL-17F and IL-17C.
Note 6 IL-17A, IL-17F, etc.
It is an inflammatory cytokine that induces inflammation and immune reactions and is known to be involved in the pathogenesis of autoimmune diseases including psoriasis.