文摘
摘要目的:评估siponimod对认知的影响在二级进展型多发性硬化症(spm)患者。
背景:认知障碍影响50 - 70%的病人和女士比复发严重进步认知加工速度(CPS)女士是最常受影响的认知领域。符号位模式测试(SDMT)和节奏的听觉串行测试(PASAT的)通常被用来评估CPS在临床试验中,尽管SDMT需要更少的工作记忆,更可靠的和敏感的。10%的回答者定义或4点变化对SDMT也成为标准。短暂的视觉空间的内存Test-Revised (BVMT-R)评估视觉/空间记忆。
设计/方法:spm病人siponimod (N = 1099)和安慰剂(N = 546)的扩展研究经历了SDMT PASAT和BVMT-R基线,在6个月(M), 12、18、24。群体间的比较,从基线进行全分析集使用重复测量模型(访问分类因素),调整后的治疗和基线的分数。亚组分析包括患者复发(rSPMS)和没有(nrSPMS)在2年前基线。持续时间6个月3和4点变化对SDMT由Cox比例风险模型来评估。
结果:在基线,意味着SDMT和PASAT的得分分别为39.09和39.10。在M24 SDMT分数提高siponimod与安慰剂(2.47分的差距调整手段,p = 0.0004), PASAT或BVMT-R成绩无显著差异。rSPMS病人,M24-SDMT M24-PASAT青睐siponimod(区别:2.57 (p = 0.0151)和2.42 (p = 0.0275))在nrSPMS病人,这种差别十分明显只有SDMT (2.44, p = 0.0099)。的风险持续SDMT变化3和4分降低了28.6% (p = 0.0002)和21.3% (p = 0.0157)和siponimod和安慰剂。
结论:rSPMS nrSPMS子组,siponimod演示了一个重要的和临床对CPS以SDMT有意义的积极影响。
研究支持:
这项研究是由诺华制药公司在瑞士巴塞尔
披露:本尼迪克特博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动已经收到个人补偿活动Actelion股价、Idec,拜耳、诺华作为顾问。克里族博士已经收到个人赔偿咨询、担任科学顾问委员会说,与Abbvie或其他活动,生原体,EMD Serono, GeNEuro,诺华,赛诺菲安万特Genzyme。克里族已经收到Acorda研究支持博士霍夫曼罗氏,落实的诺华,Receptos和梯瓦。Tomic博士已经收到个人赔偿咨询、担任科学顾问委员会说,诺华制药公司的员工或其他活动。福克斯博士已经收到个人赔偿咨询、担任科学顾问委员会说,与获得赔偿或其他活动担任顾问或演讲者从Allozyne Avanir, Idec,诺华,Questcor,和梯瓦制药产业。福克斯博士收到生原体研究支持(临床试验合同)和诺华(研究支持)。Giovannoni博士已经收到个人赔偿咨询、担任科学顾问委员会说,与获得赔偿或其他活动参与顾问委员会有关临床试验设计、试验指导委员会和数据和安全监测委员会:Abbvie, Almirall, Atara生物生原体,Sanofi-Genzyme,基因泰克,葛兰素史克公司,默克公司诺华。Giovannoni博士获得了个人在一篇社论中补偿容量为爱思唯尔MSARDs的编辑。Giovannoni博士接受了武田的研究支持。酒吧或者博士没有披露。 Dr. Gold has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, and Novartis. Dr. Gold has received personal compensation in an editorial capacity for Therapeutic Advances in Neurological Diseases, Experimental Neurology and the Journal of Neuroimmunology. Dr. Gold has received research support from Teva Pharmaceutical Industries Ltd., Biogen Idec, Bayer Schering Pharma, Genzyme, Merck Serono, and Novartis. 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. Pohlmann has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Novartis Pharma AG. Dr. Karlsson has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Novartis. Dr. Dahlke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Novartis. Dr. Kappos has received research support from Bayer HealthCare Pharmaceuticals, Biogen, F. Hoffmann-La Roche Ltd and Genentech,Novartis, Research grants from: the European Union, Roche Research Foundation, Swiss Multiple Sclerosis Society and Swiss National Research Foundation.
