文摘
摘要目的:评估疗效/安全阿仑单抗在8年(y) CARE-MS II的病人。
背景:在CARE-MS二世(NCT00548405),阿仑单抗(12毫克/天;基线:5天;12个月后:3天)显著提高临床/核磁共振结果与复发缓和女士的SC IFNB-1a / 2 y(名RRMS)患者对之前治疗反应不足。功效是保持在一个4 y扩展(NCT00930553),病人可以接受额外的,需阿仑单抗(12毫克/天,3天;疾病活动≥12个月)或其他疾病修饰治疗(DMT)调查员自由裁量权。在最初4 y扩展后,患者可以继续在黄玉(NCT02255656),一个额外的5 y扩展。
设计/方法:黄玉的患者可以接受额外的阿仑单抗(≥12个月)或其他DMT(在任何时候),每个调查员的自由裁量权。
结果:300/435例(69%)完成Y2黄玉启动阿仑单抗后(日元)。44%收到额外的阿仑单抗和另一个DMT通过日元。在日元,复发年率0.18;85%的人不复发。从核心研究基线日元,70%的患者有稳定/ eds分值提高;变化是+ 0.17 eds评分的平均值。通过日元,64%的患者免费6个月确认残疾恶化;47%达到6个月确认残疾改进。在日元,58%的患者没有疾病活动的证据,70%是MRI疾病活动的自由,89%是免费的新Gd-enhancing病变,70%是免费的新/扩大T2 hyperintense病变。平均累积脑容量损失(BVL)从基线到日元−1.06%; annual BVL was ≤0.19% in Y3–8. Incidence of overall adverse events (AEs) and infections decreased through Y8. Thyroid AE incidence peaked at 17% in Y3, declining thereafter.
结论:阿仑单抗临床效果、MRI和BVL结果保持在8 y没有连续治疗CARE-MS II的病人,一个一致的和可管理的安全性。
披露:Singer已收到个人赔偿咨询、担任科学顾问委员会说,与Acorda疗法或其他活动,拜耳,生原体,EMD Serono,基因泰克,诺华制药、赛诺菲安万特Genzyme, Teva。Singer收到Acorda研究支持疗法,Alkermes公司生原体,落实的诺华,罗氏公司,赛诺菲安万特Genzyme。Alroughani博士已经收到个人赔偿咨询、担任科学顾问委员会说,与拜耳或其他活动,生原体,Biologix, Genpharm,葛兰素史克SmithKline, Lundbeck公司,它是一家默克公司Serono,诺华公司和赛诺菲。Alroughani博士收到拜耳,研究支持生原体,Biologix, Genpharm,葛兰素史克SmithKline, Lundbeck公司,它是一家默克公司Serono,诺华公司和赛诺菲。Broadley博士已经收到个人赔偿咨询、担任科学顾问委员会说,与Bayer-Schering或其他活动,生原体,默克公司Serono,诺华公司和赛诺菲。Broadley博士接到生原体研究支持。博士Eichau Madueno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,默克公司Serono,诺华,罗氏公司,赛诺菲,Teva。哈博士已经收到个人赔偿咨询、担任科学顾问委员会说,与拜耳医疗或其他活动,生原体,Geneuro, Genzyme,落实的默克公司Receptos Celgene公司,诺华,罗氏,CSL贝林。Havrdova博士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,生原体,Celgene公司,默克公司诺华赛诺菲Genzyme和梯瓦。金医生已收到个人赔偿咨询、担任科学顾问委员会说,与Celltrion或其他活动,卫材、HanAll生物制药,MediImmune,默克公司Serono,诺华制药、赛诺菲安万特Genzyme, Teva-Handok。 Dr. Kim has received personal compensation in an editorial capacity for co-editor for MS Journal-Experimental, Translational and Clinical and Journal of Clinical Neurology. Dr. Nakamura has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroRx Research and Sanofi Genzyme. Dr. Nakamura has received royalty, license fees, or contractual rights payments from license fee from Biogen Idec. Dr. Nakamura has received research support from Biogen Idec, Sanofi Genzyme, and Novartis. Dr. Navas has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer-Schering Pharma, Genzyme, Merck Serono, Novartis, Roche, and Stendhal. Dr. Navas has received research support from Merck Serono, Novartis, and Roche. Dr. Pozzilli has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Biogen, Merck, Novartis, Sanofi, and Teva. Dr. Pozzilli has received research support from Actelion, Biogen, Merck, Novartis, Sanofi, and Teva. Dr. Rovira has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Bayer, Biogen, Bracco, Icometrix, Novartis, Roche, Sanofi, and SyntheticMR. Dr. Vermersch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Bayer, Biogen, Celgene, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, Servier, and Teva. Dr. Vermersch has received research support from Almirall, Bayer, Biogen, Celgene, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, Servier, and Teva. Dr. Wray has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alkermes, Bayer, Biogen, EMD Serono, Genentech/Roche, Novartis, Sanofi, Teva, and TG Therapeutics. Dr. Chung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi-Aventis Pharmaceuticals, Inc. Dr. Daizadeh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi. Dr. Afsar has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi. Dr. Selmaj has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Celgene, Novartis Pharmaceuticals, Synthon, Merck, Roche, and Biogen. Dr. Selmaj has received research support from Merck..
