文摘
摘要目的:评估的有效性satralizumab SA237 SAkuraSky子组的研究(NCT02028884)。
背景:Satralizumab,回收anti-IL-6受体单克隆抗体,显著降低协议定义复发的风险(PDR) NMOSD患者62%与安慰剂相比,除了基线处理的总人口SAkuraSky研究。在基线,66.3%的患者AQP4-antibody (Ab)积极和33.7%是AQP4-Ab负面的。
设计/方法:SAkuraSky是一个随机、双盲、第三阶段研究satralizumab相比安慰剂作为附加基线治疗(免疫抑制剂和/或糖皮质激素,在一个稳定的剂量)。受试者被随机分配到satralizumab南卡罗来纳州(120毫克)或安慰剂在周0,2,4,Q4W之后。主要终点是时候第一PDR、临床终点委员会裁决。预先确定子群分析包括评估响应治疗AQP4-Ab serostatus,基线治疗和地区。群体间的风险比率是基于Cox比例风险模型。
结果:Satralizumab风险减少79%的PDR与安慰剂相比动/ NMOSD AQP4-Ab积极子群(HR 0.21;95%可信区间,0.06 - -0.75)。复发比例免费周48和96年分别为91.5%(95%可信区间,69.6% - -97.8%)和91.5%(95%可信区间,69.6% -97.8%)satralizumab和59.9%(95%可信区间,36.3% -77.3%)和53.3%(95%可信区间,29.3% -72.4%)与安慰剂组,分别。动/ NMOSD AQP4-Ab负子群,satralizumab显示PDR的风险减少34%相比安慰剂(HR 0.66;95%置信区间,0.20 - -2.23),复发比例免费周48和96年分别为84.4%(95%可信区间,50.4% - -95.9%)和56.3%(95%可信区间,24.2% -79.2%)与satralizumab和75.5%(95%可信区间,41.6% -91.4%)和67.1%(95%可信区间,34.2% -86.2%)与安慰剂组,分别。
结论:子群的数据表明,satralizumab是有效地降低PDR,尤其是动/ NMOSD AQP4-Ab阳性患者。结果和结论从额外的子组将在会议上提出。
披露:Yamamura博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动与日本有限公司,武田制药有限公司,有限公司,诺华制药株式会社、三菱田边制药公司,日本住友制药有限公司,有限公司,第一三共制药有限公司,有限公司医疗审查有限公司Chiome生物科学有限公司Miraca研究所。Yamamura博士已经收到赔偿在田边三菱制药公司的董事会,诺华,日本,Santen,雅培日本卫材、日本,日本住友,拜耳控股和安斯泰来制药公司和武田制药有限公司. .Yamamura博士收到义制药株式会社、研究支持有限公司日本有限公司,诺华制药株式会社Chiome生物科学公司,Miraca研究所。Kleiter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,Chugai,默克公司,诺华制药、罗氏公司和赛诺菲安万特Genzyme。藤博士已经收到个人赔偿生原体,Mitsubishi-Tanabe,武田,诺华、卫材、日本,帝人,小野,朝日医疗、Apothecom。宫博士已经收到个人赔偿咨询、担任科学顾问委员会说,与默克公司Serono或其他活动,Idec,诺华,Teva, Chugai制药公司和拜耳先灵葆雅,Alexion,罗氏公司Genzyme,落实EuroImmun, MedDay、容忍和ARGENX . .宫博士收到女士的社会,研究支持Guthie杰克逊基金会NIHR,牛津健康服务研究委员会,伊甸园,MRC, GMSI,约翰。格林伯格博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动与诺华,Alexion EMD Serono。格林伯格博士已经收到Chugai研究支持,落实的基因泰克,MedDay, PCORI, NIH, nms Guthy杰克逊慈善基金会为动。Zakrzewska-Pniewska博士已经收到和/或接收支持科学会议和咨询工作从罗氏谢礼,Chugai,生原体,默克公司诺华公司,拜耳,落实的Teva,赛诺菲-安万特和爱力根。 Dr. Patti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Almirall, Bayer, Biogen, Celgene, Merck, Myalin, Novartis, Roche, Sanofi-Genzyme and Teva. Dr. Patti has received research support from MIUR (Ministero Italiano della Università della Ricerca Scientifica), FISM (Fondazione Italiana Sclerosi Multipla), Biogen and Merck. Dr. Tsai has nothing to disclose. Dr. Saiz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck-Serono, Sanofi, Biogen, Roche, TEVA, Novartis, and Bayer-Schering. Dr. Haramura has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Chugai Pharmaceutical Co., Ltd. Dr. Terada has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Chugai Pharmaceutical Co., Ltd. Dr. Kawata has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Chugai Pharmaceutical Co., Ltd. Dr. De Seze has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Sanofi-Genzyme, Teva, Novartis, Roche, Chugai, and Alexion. Dr. De Seze has received research support from Sanofi.
