Cancer Immunotherapy and Regenerative Medicine Department, Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran; Student's Research Committee, Semnan University of Medical Sciences, Semnan, Iran.
Department of Neurology, School of Medicine and Isfahan Neuroscience Research Centre, Isfahan University of Medical Sciences, Isfahan, Iran.
Int Immunopharmacol. 2018 Sep;62:109-113. doi: 10.1016/j.intimp.2018.06.032. Epub 2018 Jul 7.
Human recombinant interferon beta (IFN-β) is one of the first line treatments for Relapsing-Remitting Multiple Sclerosis (RRMS). However, the production of neutralizing antibodies (NAb) can impair its function. The aim of this study was to investigate the production of neutralizing antibodies against Rebif® and ReciGen® (two brands of IFN-β-1a) and to evaluate its correlation with Expanded Disability Status Scale (EDSS).
Serum samples of 71 RRMS patients (34 in ReciGen®, 37 in Rebif® group) were collected. Neutralizing antibody was measured by Myxo-virus resistance protein A (MxA) assay using A549 cell line. The MxA concentration was measured by enzyme-linked immunosorbent assay (ELISA) kit.
The median period of treatment with IFN-β-1a was 18 months in ReciGen® and 24 months in Rebif® arms. The percentage of patients with positive titer of neutralizing antibody (NAb+) had no statistically significant difference between groups (P = 0.6). In both ReciGen® and Rebif® groups, the increase in EDSS score was significantly higher in NAb+ patients compared to NAb- patients (p ≤ 0.05). The duration of using ReciGen® or Rebif® for >24 months was influential in the NAb positivity (OR = 3.78).
Receiving interferon beta-1a for >24 months is correlated with higher possibility of NAb production. The type of IFN-β used in the study had no significant impact on NAb positivity. In addition, both groups had comparable EDSS score changes, and NAb status of patients was correlated with their EDSS score.
人重组干扰素 β（IFN-β）是治疗复发缓解型多发性硬化症（RRMS）的一线治疗药物之一。然而，中和抗体（NAb）的产生会使其功能受损。本研究旨在调查针对 Rebif®和 ReciGen®（两种 IFN-β-1a 品牌）产生中和抗体的情况，并评估其与扩展残疾状况量表（EDSS）的相关性。
收集了 71 例 RRMS 患者（ReciGen®组 34 例，Rebif®组 37 例）的血清样本。通过使用 A549 细胞系的 Myxo-virus resistance protein A（MxA）测定法测量中和抗体。通过酶联免疫吸附测定（ELISA）试剂盒测量 MxA 浓度。
在 ReciGen®组和 Rebif®组中，IFN-β-1a 的中位治疗期分别为 18 个月和 24 个月。两组患者的中和抗体阳性率（NAb+）无统计学差异（P=0.6）。在 ReciGen®和 Rebif®组中，与 NAb-患者相比，NAb+患者的 EDSS 评分增加显著更高（p≤0.05）。使用 ReciGen®或 Rebif®>24 个月与 NAb 阳性率相关（OR=3.78）。
接受干扰素 β-1a>24 个月与产生 NAb 的可能性增加相关。研究中使用的 IFN-β 类型对 NAb 阳性率没有显著影响。此外，两组的 EDSS 评分变化相当，患者的 NAb 状态与 EDSS 评分相关。
