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自从常规分析中和抗体成为临床实践以来,针对干扰素β的抗体的流行率已经降低。

Prevalence of anti-drug antibodies against interferon beta has decreased since routine analysis of neutralizing antibodies became clinical practice.

机构信息

Department of Clinical Neuroscience, Karolinska Institutet, Sweden.

出版信息

Mult Scler. 2012 Dec;18(12):1775-81. doi: 10.1177/1352458512446036. Epub 2012 May 2.

Abstract

BACKGROUND

Neutralizing antibodies (NAbs) against interferon beta (IFNβ) lead to loss of treatment efficacy in multiple sclerosis patients. The seroprevalence of NAbs in multiple sclerosis patients treated with IFNβ during 2003-2004 was 32% in a cross-sectional analysis of routine data.

OBJECTIVES

The aim of this study was to investigate whether the seroprevalence of NAbs, the levels of NAb titres and the IFNβ preparations used for treatment of multiple sclerosis patients had changed in 2009-2010.

METHODS

This study included 1296 patients, analysed for NAbs with the myxovirus resistance protein A gene expression assay in 2009-2010.

RESULTS

The seroprevalence of NAbs had decreased to 19% in 2009-2010, which is significantly lower compared with the previous study in 2003-2004 (p<0.0001). This decrease was attributed to the IFNβ-1a preparations only, not to IFNβ-1b. The frequency of patients with high positive titres decreased the most, from 16% to 7% (p<0.0001).

CONCLUSIONS

NAb seroprevalence has decreased since NAb monitoring became clinical practice in 2003, especially for patients with high NAb titres. This might be due to the stricter monitoring of NAb titres that prompt NAb positive patients to stop treatment, to preferential use of less immunogenic drugs and to alteration of drug formulations.

摘要

背景

针对干扰素β(IFNβ)的中和抗体(NAb)会导致多发性硬化症患者失去治疗效果。2003-2004 年对常规数据进行的横断面分析显示,接受 IFNβ治疗的多发性硬化症患者中 NAb 的血清阳性率为 32%。

目的

本研究旨在调查 2009-2010 年,多发性硬化症患者中 NAb 的血清阳性率、NAb 效价水平以及用于治疗的 IFNβ制剂是否发生了变化。

方法

本研究纳入了 1296 例患者,于 2009-2010 年采用抗甲病毒蛋白基因表达分析(myxovirus resistance protein A gene expression assay)检测 NAb。

结果

2009-2010 年 NAb 的血清阳性率下降至 19%,与 2003-2004 年的先前研究相比显著降低(p<0.0001)。这种下降仅归因于 IFNβ-1a 制剂,而非 IFNβ-1b。高阳性效价患者的频率下降最多,从 16%降至 7%(p<0.0001)。

结论

自 2003 年 NAb 监测成为临床实践以来,NAb 血清阳性率下降,尤其是高 NAb 效价患者。这可能是由于更严格地监测 NAb 效价,促使 NAb 阳性患者停止治疗,更倾向于使用免疫原性较低的药物以及改变药物制剂。

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