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多发性硬化症患者抗那他珠单抗抗体的早期发育。

Early development of anti-natalizumab antibodies in MS patients.

机构信息

Research Laboratory, Institute of Clinical Neurosciences, Hospital Regional Universitario Carlos Haya, Hospital Civil, Pabellón 5, sótano, 29009 Málaga, Spain.

出版信息

J Neurol. 2013 Sep;260(9):2343-7. doi: 10.1007/s00415-013-6991-2. Epub 2013 Jun 14.

Abstract

The purpose of this study is to monitor the development of anti-natalizumab antibodies to evaluate their first appearance in multiple sclerosis patients, since their presence has been associated with a reduction in the efficacy of the treatment and an increase of adverse events. A total of 134 multiple sclerosis patients were included in the trial. Anti-natalizumab antibodies were monthly detected by ELISA up to the first year of treatment and subsequently, a determination was made at 18 months. 15.7% of the patients were positive, being 7.5% transiently positive and 8.2% persistently positive. The first appearance of anti-natalizumab antibodies occurred after the first month of treatment onset in 72% of positive patients; 18% did so after the second month, and 9.7% after the third month. Antibodies were never detected for the first time after the fourth infusion. The development of anti-natalizumab antibodies occurs very early after treatment onset. This observation should be considered when standardizing the follow up of patients treated with this drug in order to minimize the risks and optimize the treatment.

摘要

本研究的目的是监测抗natalizumab 抗体的发展,以评估其在多发性硬化症患者中的首次出现,因为它们的存在与治疗效果降低和不良事件增加有关。共有 134 名多发性硬化症患者参与了试验。在治疗的第一年,通过 ELISA 每月检测抗 natalizumab 抗体,随后在 18 个月时进行测定。15.7%的患者呈阳性,其中 7.5%为一过性阳性,8.2%为持续性阳性。在 72%的阳性患者中,抗 natalizumab 抗体在治疗开始后的第一个月出现;18%在第二个月出现,9.7%在第三个月出现。在第四个输液后从未第一次检测到抗体。抗 natalizumab 抗体在治疗开始后很快就出现了。在对接受该药物治疗的患者进行标准化随访时,应考虑到这一观察结果,以最大限度地降低风险并优化治疗。

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