Blood:长效重组VIII Fc融合蛋白药物Eloctate对严重A型血友病安全有效(A-LONG研究)

2013-11-20 MedSci MedSci原创

    Biogen Idec公司和瑞典Biovitrum公司宣布,该公司长效重组凝血因子VIII Fc融合蛋白药物ELOCTATE的临床3期研究(A-LONG研究)已完毕,研究成果发表在 Blood上,证明该药对严重的A型血友病患者安全有效,预防性注册该药,能够有效预防或减少出血。A-LONG研究是一个全球性的,开放标签,多中心3期研究,评估ELOCTATE的有效性,安全性和

    Biogen Idec公司和瑞典Biovitrum公司宣布,该公司长效重组凝血因子VIII Fc融合蛋白药物ELOCTATE的临床3期研究(A-LONG研究)已完毕,研究成果发表在 Blood上,证明该药对严重的A型血友病患者安全有效,预防性注册该药,能够有效预防或减少出血。

A-LONG研究是一个全球性的,开放标签,多中心3期研究,评估ELOCTATE的有效性,安全性和药代动力学( PK ) 。这项研究涉及60个血友病治疗中心,在六大洲19个国家,共招募了165例12岁及以上男性重型A型血友病患者。165位患者分为个性化注射药物 prophylaxis (25-65 IU/kg every 3-5 days, n = 118)和每周注射一次prophylaxis (65 IU/kg, n = 24),以及episodic 治疗(10-50 IU/kg, n = 23)。研究终点包括年出血率annualized bleeding rate (ABR),中和抗体出现,以及严重不良事件.该药半衰期为19小时,比此前药和半衰期长1.5倍.中位ABRs在三组分别为1.6, 3.6,和33.6.明显优于传统药物治疗。不良事件的发生多比较轻微,如鼻咽炎(感冒) ,关节痛(关节痛) ,头痛,上呼吸道感染,包括最常见的(发生率> = 5%),围手术期外发生。
    ELOCTATE使用的技术称为Fc融合,以延长治疗的时间在体内循环,这可能会延长预防性注射的间隔时间。现有的治疗需要预防性注射两到三次,每周或隔日。 ELOCTATE管理个性化的预防性治疗(每三到五天,个别需要根据药代动力学[PK]进行剂量调整) ,以及每周一次的预防性治疗。

    “这项研究标志着第一次同行评审出版物关键的第三阶段报告结果的潜在的长期持久的人与A型血友病的治疗选项,说:” Birgitte Volck博士如是说, “血友病患者有极大的兴趣,有潜力的选项,以减少必要的预防性注射,以防止或减少出血事件的频率。 ”

原始出处:

Phase 3 study of recombinant factor VIII Fc fusion protein in severe hemophilia A.

Mahlangu J, Powell JS, Ragni MV, Chowdary P, Josephson NC, Pabinger I, Hanabusa H, Gupta N, Kulkarni R, Fogarty P, Perry D, Shapiro A, Pasi KJ, Apte S, Nestorov I, Jiang H, Li S, Neelakantan S, Cristiano LM, Goyal J, Sommer JM, Dumont JA, Dodd N, Nugent K, Vigliani G, Luk A, Brennan A, Pierce GF.

Blood. 2013 Nov 13

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    2013-12-04 juliusluan78
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    2014-06-30 windight
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    2014-01-04 habb
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    2013-11-22 licz0427