文摘
摘要目的:报告复发缓和多发性硬化患者的基线特征(名RRMS)进入前瞻性多中心、非盲、阶段希望和弦研究(NCT02637856)评估的有效性和安全性ocrelizumab足够在患者不良反应的疾病修饰治疗(DMT)。
背景:名RRMS患者经常经历疾病活动尽管接收DMT。Ocrelizumab演示与干扰素疗效优于beta-1a两三期试验(歌剧我;歌剧II)患者的复发。
设计/方法:关键的合格标准包括疾病持续时间≤12年,前6个月治疗≥≥1 DMT,与接触≤3与儿童,和最近的中止DMT由于疾病控制不佳,定义为≥1临床报道复发,≥1钆增强病变T1或≥2新/扩大T2病灶。Ocrelizumab管理作为600毫克每24周,静脉输液≥96周,4剂量,两个给定的初始剂量300毫克注入,14天。
结果:在和弦的研究中,608名患者(72%女性)登记和治疗,平均37.2(8.6)岁(SD)在基线。均值(SD)基线eds得分是2.5 (1.3);意味着(SD)持续时间以来第一次出现症状女士为5.4(3.2)年。大多数病人收到一个(56%)或两个(36%)与儿童入学前。最常用的DMT立即登记之前glatiramer醋酸(49%)。最常见的排位赛事件研究包含临床复发;44%的患者有≥1复发,没有MRI活动的证据,在招生。
结论:和弦的研究中,在美国和加拿大进行的,将描述ocrelizumab治疗的有效性和安全性的患者在疾病早期和持续的疾病活动而接受另一个不同。
研究支持:
由基因泰克公司。
披露:红博士已经收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,拜耳,Genzyme,基因泰克。红博士获得了个人在一篇社论中补偿Medlink能力。红色博士已经收到了从生原体研究支持,诺华公司,拜耳,Malinkrodt, Serono,基因泰克。Bermel博士已经收到个人赔偿咨询、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。Weinstock-Guttman博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动与魏因斯托克比安卡-格特曼收到酬金作为演讲者和顾问Idec,梯瓦制药、EMD Serono, Genzyme&Sanofi,诺华和Acorda。Weinstock-Guttman博士收到Weinstock-Guttman博士的研究支持研究资金收到Idec,梯瓦制药、EMD Serono, Genzyme&Sanofi,诺华,Acorda。Selchen博士已经收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,Teva, Serono,罗氏公司,诺华,赛诺菲。Leist博士已经收到个人赔偿咨询、担任科学顾问委员会说,基因泰克或其他活动,生原体,EMD Serono Teva, Sanofi-Genzyme,拜耳。Leist博士获得了研究支持约翰逊和约翰逊(Acelion);诺华、生原体Chugai Alkermes公司基因泰克。 Dr. Cutter has nothing to disclose. Dr. Stankiewicz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genentech, Genzyme, Teva neuroscience, Bayer, Novartis, Biogen Idec. Dr. Zheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Compensation from Genentech and stock in F. Hoffmann-La Roche Ltd as Genentech employee. Dr. Musch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Genentech. Dr. Csoboth has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Compensation from Genentech and stock in F. Hoffmann-La Roche Ltd as Genentech employee. Dr. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with has served on advisory boards and data monitoring or steering committees, has held consulting agreements or has received speaker honoraria from AbbVie, Alkermes, Biogen, Bionest, Clene Nanomedicine, EMD Serono, Forward Pharma, MedDay, Pharmaceuticals, Nov. Dr. Wolinsky has received royalty, license fees, or contractual rights payments from royalties for monoclonal antibodies out-licensed to Chemicon International through UTHealth.
