Institute of Clinical Neurosciences, Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Mult Scler. 2011 Mar;17(3):368-71. doi: 10.1177/1352458510385508. Epub 2010 Dec 21.
Natalizumab is a monoclonal antibody shown to be highly effective in the treatment of relapsing-remitting multiple sclerosis (RRMS). Patients treated with natalizumab can develop antibodies directed against this agent that may affect the efficacy and safety of the drug. In this observational study, the kinetics of the appearance and the incidence of anti-natalizumab antibodies were followed prospectively for 18 months in a cohort of 64 consecutive patients treated with natalizumab for relapsing MS. Blood samples were drawn immediately before starting natalizumab therapy and each month afterwards. The presence of antibodies against natalizumab was assessed by enzyme-linked immunosorbent assay (ELISA) in all patients. Anti-natalizumab antibodies were detected in nine (14.1%) natalizumab-treated patients, three (4.68%) of whom were transiently positive while six (9.37%) were persistently positive (these patients discontinued natalizumab). All positive titres were observed during the first 4 months of treatment. One patient with a hypersensitivity reaction also had persistent antibodies. We conclude that antibodies against natalizumab develop early, within the first 6 months of therapy with natalizumab. Although no antibodies were detected after 4 months of therapy in this particular study, this does not rule out their development later on in exceptional cases.
那他珠单抗是一种单克隆抗体，已被证明在治疗复发缓解型多发性硬化症（RRMS）方面非常有效。接受那他珠单抗治疗的患者可能会产生针对该药物的抗体，这可能会影响药物的疗效和安全性。在这项观察性研究中，我们前瞻性地随访了 64 例连续接受那他珠单抗治疗 RRMS 的患者，在 18 个月的时间里监测了该抗体出现的动力学和发生率。在开始那他珠单抗治疗前以及此后的每个月，都抽取了患者的血样。通过酶联免疫吸附试验（ELISA）在所有患者中评估针对那他珠单抗的抗体。在 9 例（14.1%）接受那他珠单抗治疗的患者中检测到了抗那他珠单抗抗体，其中 3 例（4.68%）为一过性阳性，6 例（9.37%）为持续性阳性（这些患者停用了那他珠单抗）。所有阳性滴度均在治疗的前 4 个月观察到。1 例过敏反应患者也存在持续性抗体。我们的结论是，针对那他珠单抗的抗体在接受那他珠单抗治疗的前 6 个月内就会早期出现。尽管在这项特定研究中，在治疗 4 个月后没有检测到抗体，但这并不能排除在特殊情况下它们会在以后出现。
