文摘
摘要目的:报告2年期阶段希望和弦研究(NCT02637856)结果评价ocrelizumab复发缓和多发性硬化患者以前的疾病修饰治疗(名RRMS)和不良反应(DMT)。
背景:复发患者Ocrelizumab优于干扰素β-1a女士(歌剧I和II)。评估Ocrelizumab有效性DMT患者的不良反应是必要的。
设计/方法:和弦意向处理(ITT)人口(N = 608)不良反应(≥1复发,≥1钆增强病变T1 (s)或≥2新/扩大T2病灶)以前DMT稳定使用后(≥6个月)。患者接受ocrelizumab 600毫克每24周≤96周。主要终点是患者的比例免费protocol-defined临床或MRI活动(事件),评价修改ITT人口估算患者提前终止为缺乏功效或死亡事件,排除病人停止其他原因没有一个事件。关键二次端点包括复发年率(ARR)和扩展残疾状态量表(eds)从基线。安全评估在ITT人口。
结果:共有555名患者完成了治疗(基线的意思(SD)持续时间以来第一个女士的症状和诊断,5.4(3.24)和4.2(3.03)年,分别)。周96年,48.1%的患者免费protocol-defined事件。大多数没有经历protocol-defined复发(89.6%),任何钆增强病变T1(95.5%)或新/扩大T2病灶(59.5%)或24周证实残疾进展(89.6%)。是0.046的ARR ITT公司调整。七十一观察复发(第一年,50;第二年,21)。在96周,大多数患者稳定(< 1点变化;61.5%)或改进(≥1点降低;22.7%)eds的水平。安全符合整体ocrelizumab安全概要文件。
结论:这个分析演示了ocrelizumab治疗反应/ 2年名RRMS患者在疾病的早期相对另一个DMT和有经验的不良反应。
披露:Weinstock-Guttman博士已经收到个人赔偿咨询、担任科学顾问委员会来说,与生原体或其他活动,诺华公司基因泰克,EMD Serono, Abbvie,迈尔斯Mallickrodt、布里斯托尔. .Weinstock-Guttman博士已经收到了从生原体研究支持,诺华公司基因泰克,EMD Serono…博士。Bermel已收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,Genzyme,基因泰克,诺华。Bermel博士已经收到版税、许可费或合同权利支付知识产权的多发性硬化性能测试,目前注册的建筑健康和生原体。Bermel博士已经收到了从生原体研究支持,基因泰克,诺华。Csoboth博士已经收到个人赔偿咨询、担任科学顾问委员会说,基因泰克公司的员工或其他活动,Inc .)和f .罗氏公司有限公司股东。刀博士已经收到个人赔偿AMO制药,Argenix, Atara Bio-therapeutics,轴突,生原体,BioLineRx, Bio-therapeutics,头脑风暴细胞疗法,查尔斯顿实验室,Inc .)点击疗法,基因泰克,Genzyme,瓦制药,地平线制药、克莱因Buendel Inc . MedDay,落实的默克公司,默克和辉瑞,Neurim,诺华OPKO生物制剂,Orphazyme,毕达哥拉斯,Inc,套索制药、Receptos / Celgene公司,赛诺菲-安万特制药,罗氏,SciFluor, Somahlution, Teva Pharma-ceuticals, TG疗法,UTHealth休斯顿Teva NeuroscienceDr。弗里德曼已经收到个人赔偿咨询、担任科学顾问委员会说,与Actelion股价或其他活动,拜耳医疗、Idec, Chugai, Clene纳米,EMD Serono加拿大,Genzyme,默克公司Serono,诺华,f .罗氏公司,赛诺菲-安万特和加拿大Teva创新。弗里德曼博士已经收到赔偿服务Actelion股价的董事会,拜耳医疗、Idec, Clene纳米,f .罗氏公司,默克公司Serono, MedDay制药、诺华公司和赛诺菲-安万特。弗里德曼博士已经收到Genzyme加拿大的研究支持。 Dr. Leist has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Leist has received research support from received consultancy fees or clinical research grants from Acorda, Bayer, Biogen, Daiichi, EMD Serono, Novartis, ONO, Pfizer, Teva Neuroscience. Dr. Ma has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Musch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd.. Dr. Reder has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Merck Serono, Novartis and TG Therapeutics. Dr. Reder has received personal compensation in an editorial capacity for MedLink. Dr. Reder has received research support from Bayer, Biogen, F. Hoffmann-La Roche Ltd, Genentech, Inc., Mallinckrodt, Merck Serono and Novartis. Dr. Stankiewicz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, Genzyme, Genentech, Inc., EMD Serono, Novartis, and Celgene.Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Received compensation for consulting, scientific advisory boards, or other activities with Alkermes, Actelion, Acorda Therapeutics, Celgene, EMD Serono, GeNeuro, GW Pharma, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanof. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from Royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.
