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Guidelines on use of anti-IFN-beta antibody measurements in multiple sclerosis: report of an EFNS Task Force on IFN-beta antibodies in multiple sclerosis.

机译:在多发性硬化症中使用抗IFN-β抗体测量的指南:关于多发性硬化症中IFN-β抗体的EFNS工作队的报告。

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摘要

Therapy-induced binding and neutralizing antibodies is a major problem in interferon (IFN)-beta treatment of multiple sclerosis. The objective of this study was to provide guidelines outlining the methods and clinical use of the measurements of binding and neutralizing antibodies. Systematic search of the Medline database for available publications on binding and neutralizing antibodies was undertaken. Appropriate publications were reviewed by one or more of the task force members. Grading of evidence and recommendations was based on consensus by all task force members. Measurements of binding antibodies are recommended for IFN-beta antibody screening before performing a neutralizing antibody (NAB) assay (Level A recommendation). Measurement of NABs should be performed in specialized laboratories with a validated cytopathic effect assay or MxA production assay using serial dilution of the test sera. The NAB titre should be calculated using the Kawade formula (Level A recommendation). Tests for the presence of NABs should be performed in all patients at 12 and 24 months of therapy (Level A recommendation). In patients who remain NAB-negative during this period measurements of NABs can be discontinued (Level B recommendation). In patient with NABs, measurements should be repeated, and therapy with IFN-beta should be discontinued in patients with high titres of NABs sustained at repeated measurements with 3- to 6-month intervals (Level A recommendation).
机译:治疗诱导的结合和中和抗体是多发性硬化症的干扰素(IFN)-β治疗中的主要问题。这项研究的目的是提供概述结合和中和抗体测量方法和临床使用的指南。对Medline数据库进行系统搜索,以获取有关结合和中和抗体的可用出版物。一个或多个工作队成员审查了适当的出版物。证据和建议的分级基于所有工作组成员的共识。建议在进行中和抗体(NAB)分析之前,对结合抗体进行测量以进行IFN-β抗体筛查(建议A级)。 NAB的测量应在专业实验室中进行,使用经过验证的细胞血清稀释度的经验证的细胞病变效应测定或MxA产生测定。应使用Kawade公式(建议A级)计算NAB滴度。应在治疗12个月和24个月的所有患者中进行NABs的检测(推荐A级)。在此期间NAB阴性的患者可以停止NAB的测量(B级推荐)。对于NAB患者,应重复测量,并应在3到6个月的间隔内重复测量持续高滴度NAB的患者中停用IFN-β治疗(建议为A级)。

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