文摘
摘要目的:评估疗效/安全阿仑单抗在7年(y)复发缓和女士从CARE-MS II(名RRMS)患者。
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SC IFNB-1a / 2 y对之前治疗反应不足患者。在4 y扩展(持久的疗效观察NCT00930553;93%的学生,86%完成),病人可以接受阿仑单抗处理需复发/ MRI活动或者接受其他疾病修饰治疗(儿童)调查员的自由裁量权。病人完成扩展可以参加黄玉(n = 336), 5 y的一项研究(NCT02255656),为进一步评价。
设计/方法:在黄玉,病人可以接受阿仑单抗再处理(≥12个月)或其他与儿童在任何时候(每个调查员的自由裁量权)。核磁共振扫描每年执行。评估:年复发率(ARR);6个月确认残疾恶化(CDW);6个月确认改善残疾(CDI);没有证据表明疾病活动(NEDA);AEs。
结果:317名患者(94%)完成了黄玉Y1启动阿仑单抗后(日元)。加勒比海盗仍然低(日元:0.14);51%的人在Y3-7不复发。稳定患者的百分比/改善eds分数与基线仍然很高(日元:73%)。在日元,69%是6个月CDW-free, 44% 6个月CDI实现。大多数病人实现NEDA每年(日元:60%)。47%收到任何额外的治疗(阿仑单抗或其他DMT)在最初的2课程。总体发病率AE, infusion-associated反应,随着时间的推移和感染下降。甲状腺AE发病率在Y3(17%)达到高峰,然后下降。
结论:阿仑单抗疗效维持7 y在CARE-MS II的病人,尽管自最初的2 47%接受没有额外治疗课程。44%的病人还显示改善残疾。阿仑单抗安全性保持一致;随着时间的推移整体AE发病率下降。阿仑单抗可能为患者提供一个独特的治疗方法,提供持久的功效没有连续的治疗。
研究支持:赛诺菲和拜耳保健药品。
披露:Singer已收到个人赔偿咨询、担任科学顾问委员会说,与Acorda或其他活动,拜耳,生原体,EMD Serono,基因泰克,诺华赛诺菲Genzyme, Teva。Singer收到Acorda研究支持,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,默克公司诺华,罗氏,Sanofi-Genzyme。Alroughani博士已经收到了从生原体研究支持,诺华,Sanofi-Genzyme。Brassat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,MedDay,默克公司Serono,诺华,Sanofi-Genzyme,罗氏,Teva。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。哈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Idec, GeNeuro,赛诺菲安万特Genzyme,默克公司,诺华制药、Octapharma, Opexa疗法,梯瓦制药、落实的拜耳医疗、医药,和罗氏。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,默克公司Serono,诺华,Receptos,罗氏公司,赛诺菲,和梯瓦;由教育部支持捷克共和国(普洛古莱问/ LF1)。 Dr. Kim has nothing to disclose. Dr. Oreja-Guevara has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alexion, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva. 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. Selmaj has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Celgene, Novartis, Merck, Roche. Dr. Vermersch has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Servier, and Teva. Dr. Vermersch has received research support from Almirall, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Servier, and Teva. Dr. Wray has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Bayer, Biogen, EMD Serono, Genzyme, Novartis, Questcor, Receptos, Genentech/Roche, Teva. Dr. Margolin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Chung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Daizadeh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Chirieac has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Coles has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi.
