文摘
摘要目的:调查的有效性和安全性teriflunomide之前定义的子组治疗合用的因果分析的第二阶段和第三阶段TEMSO学习,塔,,核心和扩展研究。
背景:teriflunomide的疗效和安全性已建立在第二阶段的研究(NCT01487096)和第三阶段TEMSO (NCT00134563),塔(NCT00751881),,(NCT00883337)的研究。
设计/方法:在核心的研究中,病人被随机分为安慰剂(阶段2 / TEMSO /塔),皮下干扰素beta-1a 44μg(干扰素)(,),或teriflunomide 7毫克或14毫克(2 / TEMSO /塔/,阶段)。在扩展,teriflunomide-treated病人继续原来的剂量(2 / TEMSO阶段)或接收14毫克不管原始剂量(塔/,),和安慰剂,或者IFN-treated患者重新分配1:1 teriflunomide 7毫克或14毫克(阶段2,TEMSO)或teriflunomide 14毫克(,,)。因果分析的年复发率(ARR)进行患者接受安慰剂或teriflunomide根据之前定义的子组治疗女士:组1,没有之前的DMT;组2,DMT之前≤6个月;和组3、DMT在之前> 6≤24个月。集中核心和扩展数据报告teriflunomide患者14毫克。将安全数据。
结果:有912、511和163名患者在组1、2和3分别。意味着调整arr(95%置信区间)在第一年和8年是0.300(0.262,0.338)和0.092(0.038,0.146)组1;0.265(0.218,0.311)和0.115(0.000,0.341)组2;0.135和0.553(0.428,0.677)和(0.000,0.288)3组,分别。
结论:在这个因果分析,加勒比海盗被降低为所有组相比,8年1。
披露:Comi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,拜耳,生原体,默克公司Serono,诺华赛诺菲,Serono座谈会国际基金会和梯瓦。弗里德曼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,Chugai, EMD加拿大,罗氏公司,默克公司Serono,诺华公司,赛诺菲安万特Genzyme Teva加拿大创新。参与公司赞助扬声器Genzyme的局。弗里德曼博士获得了个人在一篇社论中补偿Actelion股价的能力,拜耳医疗、生原体,罗氏公司,默克公司Serono,诺华,Opexa,赛诺菲Genzyme。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、生原体,罗氏公司,默克公司Serono,诺华,Opexa,赛诺菲Genzyme。台面式晶体管博士Lallana已收到个人赔偿咨询、担任科学顾问委员会说,与Almirall或其他活动,生原体,Genzyme,默克公司Serono,诺华,罗氏公司和梯瓦。Vermesch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,罗氏、诺华、Teva,赛诺菲,Celgene公司Actelion股价和默克。Vermesch博士已经收到罗氏的研究支持,赛诺菲,诺华和生原体。金医生没有披露。Parajeles博士没有披露。 Dr. Edwards has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Genzyme, EMD Serono. Dr. Edwards has received research support from Biogen, Eli Lilly, Genentech, Genzyme/Sanofi, Hoffmann-La Roche, and Novartis. Dr. Gold has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Baxter, Bayer Schering, Biogen, CLB Behring, Celgene, Genzyme, Merck Serono, Novartis, Roche, Stendhal, Talecris, and Teva Pharmaceuticals. 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. Overell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi Genzyme, Roche, Biogen, Merck Serono, Medday, Web MD Global, Allergan and Novartis. Dr. Overell has received personal compensation in an editorial capacity for I serve on the steering group for the Neurocompass website, funded by Biogen. Dr. Overell has received research support from Sanofi Genzyme, Roche, Biogen and Novartis. Dr. Korideck has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi. Dr. Chavin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi-Aventis Pharmaceuticals, Inc. Dr. Poole has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Sanofi. Dr. Coyle has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Received consulting fees from Accordant, Acorda, Bayer, Biogen Idec, Celgene, Genentech/Roche, Genzyme/Sanofi, Novartis, Serono and Teva. Dr. Coyle has received research support from Research support from Actelion, Genentech/Roche, MedDay, Novartis and NINDS.
