Fingolimod减少复发缓和多发性硬化患者复发年率:自由二研究亚组分析(P07.102)

文摘

摘要目的:报告fingolimod与安慰剂对年复发率的影响(ARR)自由II预定义的患者亚组。

背景:自由二世是一个两年,双盲,随机,安慰剂对照研究评估患者接受fingolimod 0.5毫克和1.25毫克。

设计/方法:病人子组是基于1)人口:年龄、性别、疾病和治疗历史2)基线活动:复发前1年或前2年研究入口之前,基线残疾和MRI的活动。总arr基于证实复发为子组提出了批准剂量的0.5毫克。

结果:71.8%(779/1083)患者完成了研究。加勒比海盗是类似的男性(fingolimod安慰剂0.22和0.35;p = 0.092,下降38.5%)和女性(fingolimod安慰剂0.21和0.41;50.3%,p < 0.001)。加勒比海盗是减少> 50%和安慰剂在年轻患者中,年龄≤40年(0.23和0.48;p < 0.001, 52.3%),有效的病人年龄> 40年(0.18和0.30;38.5%,p = 0.013)。以前治疗和首次治疗病人少ARR与安慰剂(0.23和0.41,p < 0.001, 44.3%;0.15和0.36,p = 0.005, 57.9%)。其他组比较:轻度残疾患者(eds < 3.0: 0.18和0.39,p < 0.001, 53.5%)和moderate-severe残疾(eds≥3.0: 0.27和0.43,p = 0.019, 37%); patients with no Gd T1 lesions (0.18 versus 0.37, p<0.001, 50.4% ), 1-2 lesions (0.26 versus 0.36, p=0.203, 25.8%) and ≥3 lesions (0.24 versus 0.65, p<0.001, 62.6%); relapses in the previous year: no relapse (0.12 versus 0.40, p=0.087, 70.2%), single relapse (0.19 versus 0.35, p<0.001, 47.1%) and ≥2 relapses (0.27 versus 0.50, p=0.003, 46.1%); relapses in the previous 2 years: single relapse (0.15 versus 0.27, p=0.036, 43.8%), 2-3 relapses (0.25 versus 0.48, p<0.001, 48.2%), >5 relapses (0.30 versus 0.67, p=0.184, 54.8%).

结论:fingolimod 0.5毫克减少ARR治疗与安慰剂比较二自由研究中无论基线人口状况、疾病活动或疾病严重程度。

诺华制药公司支持:瑞士巴塞尔。

披露:Goodin博士已经收到个人活动与Ares-Serono补偿,默克公司Serono,诺华,Berlex实验室,拜耳先灵葆雅医疗、Idec,先灵葆雅AG)和Teva神经科学。Goodin博士已经收到了诺华的研究支持。杰弗瑞博士已经收到个人活动与补偿Berlex实验室、公司,葛兰素史克,Inc .)、辉瑞(pfe . n:行情),Serono Inc .和梯瓦神经学。Jeffrey博士已经收到Berlex研究支持,辉瑞公司,Serono Inc .和梯瓦神经学。卡珀斯博士接受个人补偿活动Actelion股价,Advancell, Allozyne, BaroFold,拜耳保健药品,拜耳先灵葆雅制药,Bayhill, Idec, BioMarin, CLC贝林,锐气,Genmark GeNeuro SA和葛兰素史克公司。卡珀斯博士获得了研究已经收到Acorda研究支持的支持,Actelion股价,Allozyne, BaroFold,拜耳医药保健、拜耳先灵葆雅,Bayhill疗法,Idec,勃林格殷格翰的发言,卫材,锐气,公司,葛兰素史克,Glenmark,默克公司Serono, MediciNova和新星。卢布林博士收到拜耳医疗药品、个人赔偿咨询Idec, EMD Serono Inc .)、诺华、辉瑞、神经科学Teva)公司,Medicinova, Actelion股价,赛诺菲-安万特(sanofi - aventis) Acorda, Questcor,罗氏,Celgene公司,雅培,强生,Revalesio Coronado生物科学,GenFL。卢布林博士获得了爱思唯尔的补偿担任联席首席编辑多发性硬化症和相关疾病。Radue博士已经收到个人活动与补偿的目的,Idec,和诺华作为顾问。Radue博士已经收到Actelion股价研究支持,拜耳制药公司、Idec,默克公司Serono,诺华。 Dr. Rammohan has received personal compensation for activities with BIOGEN IDEC, TEVA, NOVARTIS, EMD SERONO, PFIZER, ROCHE GENENTECH, QUESTCOR AND ACORDA as a speaker and consultant. Dr. Rammohan has received research support from BIOGEN IDEC, TEVA, EMD SERONO, NOVARTIS, GSK, NIH, ACORDA. Dr. Reder has received personal compensation for activities with Bayer, Genentek, Genzyme, Merck, Novartis, Questcor, Serono, Teva Neuroscience, Caremark, Canadian MSS, NMSS, State of IL, State of IN. Dr. Reder received personal compensation in an editoral capacity for Medlink/Neurobase electronic journal. Dr. Vollmer has received personal compensation for activities with Genzyme Corporation, Acorda Therapeutics, Accelerated Cure Projects for MS, Bristol-Myers Squibb Company, Teva Neuroscience, Biogen Idec, Novartis, and Hoffman-LaRoche. Dr. Vollmer has received research support from Teva Neuroscience, Genzyme Corporation, Ono Pharmaceutical, Biogen Idec, Janssen, and the National Institutes of Health. Dr. Agius has received personal compensation for activities with Teva Neuroscience, Biogen Idec, Berlex Labs and Serono as a speaker and consultant. Dr. Agius has received research support from Novartis, Teva, Biogen, Genzyme, Roche, Immune Tolerance Network, Actelion, and Acorda. Dr. Stites has received personal compensation for activities with Novartis Pharmaceuticals Corporation as an employee. Dr. Li has received personal compensation for activities with Novartis as an employee. Dr. Cappiello has received personal compensation for activities with Novartis. Dr. Von Rosenstiel has received personal compensation for activities with Novartis. Dr. Calabresi has received personal compensation for activities with Biogen Idec, Teva Neuroscience, Genzyme Corporation, Vaccinex, Vertex, and Novartis. Dr. Calabresi has received research support from the National Institutes of Health, the National Multiple Sclerosis Society, Nancy Davis Foundation, Biogen Idec, Vertex, Genentech, Inc., Abbott, and Bayer.