文摘
摘要目的:免疫球蛋白的时间演变特征(Ig)水平和严重感染的风险(SIs)第三阶段基线搞笑四分位数的歌剧我(NCT01247324),歌剧二世(NCT01412333)和清唱剧(NCT01194570)审判ocrelizumab多发性硬化症,开放的扩展。
背景:减少血清观察搞笑水平超过6年的ocrelizumab治疗,剩下搞笑水平高于正常的下限(LLN)对于大多数病人。明显减少之间的联系搞笑水平和SIs以前报道。
设计/方法:血清搞笑水平测量至少每24周。基线免疫球蛋白,IgM IgA四分位数(g / L)测定对歌剧、清唱剧;Q1代表患者基线水平最低。LLNs免疫球蛋白,IgM IgA被定义为5.65 g / L, 0.40 g / L和0.70 g / L,分别。一段搞笑< LLN和SI利率每基线质量进行评估。
结果:超过6年的治疗,意味着免疫球蛋白水平的变化,g / L(变化百分比)每年基线四分位数:Q1,−0.24 (−2.9%);Q2,−0.32 (−3.2%);第三,−0.40 (−3.6%);第四季度,−0.40(−3.0%)在歌剧,Q1,−0.23 (−2.9%);Q2,−0.28 (−2.9%);第三,−0.35 (−3.1%);第四季度,−0.51(−3.8%)清唱剧。如果利率/ 100 (95% CI)白细胞数量:Q1, 1.63 (0.95 - -2.61);Q2, 1.55 (0.90 - -2.48);第三,1.51 (0.86 - -2.45); Q4, 1.11 (0.57–1.94) in OPERA, and Q1, 4.04 (2.66–5.87); Q2, 3.81 (2.46–5.62); Q3, 5.39 (3.76–7.50); Q4, 2.17 (1.22–3.59) in ORATORIO. Changes in IgM/IgA levels, and patient demographics and disease characteristics, for each quartile will also be presented.
结论:低基线患者免疫球蛋白水平少了绝对免疫球蛋白下降与患者免疫球蛋白高基线水平。在四分位观察类似的百分比跌幅。总体而言,利率的SIs /基线免疫球蛋白四分位相似,仍然很低。
披露:阿米特酒吧或作为一个演讲者参与会议主办,并得到了咨询费,Atara Biotherapeutics, Idec, Celgene公司/ Receptos Genentech /罗氏,詹森/ Actelion股价,MAPI,落实默克/ EMD Serono,诺华和Sanofi-Genzyme。格兰特詹森的支持/ Actelion股价,Atara Biotherapeutics, Idec, Celgene公司/ Receptos,罗氏/基因泰克,MAPI,落实默克/ EMD Serono,诺华和Sanofi-Genzyme.Dr。Bermel已收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,Genzyme,基因泰克,诺华。Bermel博士已经收到版税、许可费或合同权利支付知识产权的多发性硬化性能测试,目前注册的建筑健康和生原体。Bermel博士已经收到了从生原体研究支持,基因泰克,诺华。博士韦伯收到了个人赔偿咨询、担任科学顾问委员会说,与m . s .韦伯收到旅行社或其他活动经费和/或演讲者从Biogen-Idec谢礼,默克公司Serono,诺华,罗氏,TEVA,拜耳和Genzyme . .韦伯博士获得了个人在一篇社论中补偿硕士的能力韦伯作为编辑的《公共科学图书馆•综合》杂志上。韦伯博士收到m . s .韦伯的研究支持接收来自德意志Forschungsgemeinschaft研究支持脱硫;我们3547/5-1),诺华,TEVA, Biogen-Idec,罗氏,默克和ProFutura哥廷根夏洛蒂的方针。休斯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f .罗氏公司有限公司林博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动在罗氏产品有限公司. . Dr. Wang has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employed at Roche Products Ltd.. Dr. Sauter has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of F. Hoffmann-La Roche Ltd. Dr. Koendgen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with · H Koendgen is an employee and shareholder of F. Hoffmann-La Roche Ltd. Dr. Koendgen has received research support from Employee and shareholder of F. Hoffmann-La Roche. Dr. Craveiro has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Hoffmann-La Roche. Dr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix. Dr. Hauser has received compensation for serving on the Board of Directors of Neurona. Dr. Hauser has received research support from F. Hoffmann-La Roche Ltd, and Novartis.Dr. Derfuss has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Tobias Derfuss serves on scientific advisory boards for Novartis Pharmaceuticals, Merck Serono, Biogen, Genzyme, GeNeuro, and Mitsubishi Pharma; has received funding for travel and/or speaker honoraria from Biogen, Genzyme, Novartis, and Merck Serono. Dr. Derfuss’ wife is an employee of Novartis and holds stock options of Novartis, which sponsored research in which Dr. Derfuss was involved as an investigator. Dr. Derfuss holds stock and/or stock options in His wife is an employee of Novartis and holds stock options of Novartis.. Dr. Derfuss has received research support from His institution received research support from Biogen and Novartis..
