文摘
摘要目的:细节其概要IgPro10丙种球蛋白和IgPro20 SCIG在慢性炎性脱髓鞘多神经病(CIDP)。
背景:路径研究的有效性和安全性SCIG (IgPro20 Hizentra®)作为CIDP的维持治疗。随机化前IgPro20或安慰剂,受试者接受丙种球蛋白撤军,在临床恶化,是re-stabilized丙种球蛋白(IgPro10, Privigen®)。IgPro10和IgPro20制造相同的唯一的区别是最后的免疫球蛋白浓度和管理路线。其档案IgPro10丙种球蛋白和IgPro20 SCIG评估。
设计/方法:丙种球蛋白re-stabilization由一个初始剂量的2 g / kg紧随其后的是3 - 4剂1克/公斤每隔三周。受试者被随机分配到每周SCIG维持治疗(0.2或0.4克/公斤)或安慰剂24周。不良事件(AE)概要和复发(变化调整炎性病变病因和治疗[INCAT]分数)对产品进行了分析。
结果:207例接受1620丙种球蛋白注入,随后115年收到了4225 SCIG注入。丙种球蛋白re-stabilization期间,48.3%的受试者有经验的AEs(率/注入0.18);27.5%是有因果联系。SCIG, AEs被报道在58%(注入率/ 0.08)和52%(注入率/ 0.05)0.2和0.4 g / kg,分别;有因果联系AEs报道在29.8%和34.5%的受试者,分别。最常见的AEs是头痛(丙种球蛋白:16.4%)和局部反应(SCIG: 19.3% 0.2;0.4)29.3%;绝大多数(分别为65%和95%)温和。头痛和恶心和丙种球蛋白更常见(16.4%和4.8%)比SCIG(7% / 0% / 6.9%和0%)。丙种球蛋白,7发生溶血AEs(所有较轻的和没有输血); none occurred with SCIG. No thromboembolic events, renal failures or deaths were reported. In total, 83% of subjects re-stabilized on IVIG; subsequently, 81% did not relapse on 0.4g/kg SCIG (0.2g/kg SCIG: 67%; placebo: 44%).
结论:丙种球蛋白和SCIG文献报告的预期效果,而系统性的AEs与SCIG剂量更低。
披露:Shebl博士已经收到个人赔偿咨询、担任科学顾问委员会说,与中超贝林GmbH或其他活动。Shebl博士已经收到赔偿在CSL贝林GmbH的董事会。贬责博士已经收到个人赔偿咨询、担任科学顾问委员会说,与中超贝林或其他活动。成Bril博士已经收到个人赔偿咨询、担任科学顾问委员会说,与中超贝林或其他活动,联合,Alnylam、Alexion, Grifols, Octapharma,夏尔,辉瑞和Bionevia。成Bril博士已经收到了来自中超贝林研究支持,联合,Alnylam、Alexion, Grifols, Octapharma,夏尔,Bionevia。Merkies博士已经收到个人赔偿咨询、担任科学顾问委员会,与Talecris来说,或其他活动。Merkies博士已经收到了个人在一篇社论中补偿能力周围神经学会》杂志上。哈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,Geneuro, Genzyme,落实的默克公司Receptos Celgene公司,诺华,罗氏,CSL贝林。刘易斯博士已经收到个人赔偿咨询、担任科学顾问委员会说,与中超贝林或其他活动,Axelacare, Pharnext,生物监测,Kedrion, NuFactor Optioncare, Grifols。刘易斯博士研究支持Neuraltus和Cytokinetics接收。 Dr. Sobue has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mitsubishi Tanabe Pharma Co; Takeda Pharmaceutical Company Limited. Dr. Lawo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring GmbH. Dr. Cornblath has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acetylon Pharmaceuticals Inc., Alnylam Pharmaceuticals, Annexon Biosciences, Akros Pharma, argenx BVBA, Biotest Pharmaceuticals, Inc., Boehringer Ingelheim, Cigna Health Management, Inc., CSL Behring, DP Clinical, Inc., Grifols S.A., Hansa Medical Inc., Karos Pharmaceuticals, Inc., Merrimack Pharmaceuticals, Inc., Neurocrine Biosciences, Novartis Corp., Octapharma AG, Pharnext SAS, Seattle Genetics, Inc., Sun Pharmaceuticals, Syntimmune. Data Safety Monitoring Board: Pfizer Inc., Ionis Pharmaceuticals, Axovant Sciences LTD., Ampio Pharmaceuticals, PledPharma, Momenta Pharma, Sanofi, GBS CIDP Foundation International. Dr. Cornblath has received personal compensation in an editorial capacity for JPNS. Dr. Cornblath has received compensation The Peripheral Nerve Society. Dr. Cornblath has received royalty, license fees, or contractual rights payments from Acetylon Pharmaceuticals Inc., Akros Pharma, AstraZeneca Pharmaceuticals, LP, Calithera Biosciences, Genentech Inc, Karos Pharma, Neurocrine Biosciences, Merrimack Pharmaceuticals, Inc. Seattle Genetics, Inc., Shire Development, LLC. Dr. Mielke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring GmbH. Dr. Van Schaik has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring, Baxter. Dr. Van Schaik has received personal compensation in an editorial capacity for Cochrane Neuromuscular Disease Group. Dr. Van Schaik has received research support from The Netherlands Organization for Scientific Research, Dutch Prinses Beatrix Fonds.
