Gonçalves Marcus Vinícius Magno, Brandão Wesley Nogueira, Longo Carla, Peron Jean Pierre Schatzmann, Dos Passos Giordani Rodrigues, Pagliarini Gabriela Löw, do Nascimento Osvaldo Jose Moreira, Marinowic Daniel Rodrigo, Machado Denise Cantarelli, Becker Jefferson
Department of Neurology, Universidade Federal Fluminense (UFF), Niterói, Brazil.
Department of Immunology, Institute of Biological Sciences, Universidade de São Paulo (ICB-USP), São Paulo, Brazil.
J Neuroimmunol. 2020 Nov 5;350:577435. doi: 10.1016/j.jneuroim.2020.577435.
Multiple Sclerosis (MS) is a chronic, autoimmune, demyelinating disease of the central nervous system (CNS). Currently, several protocols are described for the different phases of MS. In this longitudinal study, we aim to quantify the concentration of plasma cytokines of MS patients treated with Fingolimod alone or after Glatiramer Acetate (GA) or Interferon-beta (IFN-β), in order to compeer both treatments and describes if it is possible to use them as biomarkers.
Compare the two different types of drug treatment and describes possible immune biomarkers in RRMS patients treated with Fingolimod alone or after GA or IFN-β.
This is a controlled, non-randomized clinical trial. Plasma concentrations of IL-31, sCD40L and nine others cytokines were evaluated in two groups of patients with a one-year follow-up. Group 1 (n = 12): RRMS patients treated with GA or IFN-β for at least six months before the study who changed therapy to Fingolimod after six months, and Group 2 (n = 12): naïve RRMS patients who started treatment with Fingolimod. We used ANOVA two-way to analyze the cytokines and Spearman coefficient to evaluate the correlation.
Although Group 2 started with a greater number of relapses per disease duration, Fingolimod treatment was effective in decreasing this parameter, as well as EDSS over 12 months. However, the treatment with GA or IFN-β on Group 1 showed a tendency to increase the number of relapses after 6 months of follow-up, which decrease when the therapy was changed to Fingolimod. After the evaluation of 11 cytokines in one year, we found that IL-31 and sCD40L were the biomarkers that demonstrated a more difference when compared to the classical ones, following the clinical pattern over the treatment period.
Our study describes the existence of two promising plasmatic biomarkers (IL-31 and sCD40L), which reduced plasmatic levels in RRMS patients followed the treatment time of Fingolimod, despite that more studies are needed to prove their efficiency.
多发性硬化症（MS）是一种中枢神经系统（CNS）的慢性自身免疫性脱髓鞘疾病。目前，针对MS的不同阶段描述了几种治疗方案。在这项纵向研究中，我们旨在量化单独使用芬戈莫德或在醋酸格拉替雷（GA）或干扰素-β（IFN-β）治疗后MS患者血浆细胞因子的浓度，以便比较这两种治疗方法，并描述是否可以将它们用作生物标志物。
比较两种不同类型的药物治疗，并描述在单独使用芬戈莫德或在GA或IFN-β治疗后复发缓解型多发性硬化症（RRMS）患者中可能的免疫生物标志物。
这是一项对照、非随机临床试验。在两组患者中评估了IL-31、sCD40L和其他九种细胞因子的血浆浓度，并进行了为期一年的随访。第1组（n = 12）：在研究前接受GA或IFN-β治疗至少六个月，六个月后改为芬戈莫德治疗的RRMS患者；第2组（n = 12）：开始使用芬戈莫德治疗的初治RRMS患者。我们使用双向方差分析来分析细胞因子，并使用斯皮尔曼系数来评估相关性。
尽管第2组在每个疾病持续时间内开始时复发次数较多，但芬戈莫德治疗在降低该参数以及12个月内的扩展残疾状态量表（EDSS）方面是有效的。然而，第1组接受GA或IFN-β治疗在随访6个月后复发次数有增加的趋势，当治疗改为芬戈莫德时复发次数减少。在对一年内的11种细胞因子进行评估后，我们发现IL-31和sCD40L是与经典细胞因子相比表现出更大差异的生物标志物，并且在治疗期间遵循临床模式。
我们的研究描述了两种有前景的血浆生物标志物（IL-31和sCD40L）的存在，尽管需要更多研究来证明它们的有效性，但在RRMS患者中，随着芬戈莫德治疗时间的延长，它们的血浆水平会降低。
