INTRODUCTION 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. OBJECTIVE 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. MATERIALS AND METHODS 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. RESULTS 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. CONCLUSIONS 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.

中文翻译：

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芬戈莫德治疗的复发缓解型多发性硬化症 (RRMS) 患者血浆 IL-31 和 sCD40L 水平的相关性


简介 多发性硬化症 (MS) 是一种慢性、自身免疫性、中枢神经系统 (CNS) 脱髓鞘疾病。目前，针对 MS 的不同阶段描述了几种协议。在这项纵向研究中，我们的目的是量化单独接受芬戈莫德治疗或接受醋酸格拉默 (GA) 或干扰素-β (IFN-β) 治疗的多发性硬化症患者的血浆细胞因子浓度，以便比较两种治疗方法并描述是否可能使用它们作为生物标志物。目的 比较两种不同类型的药物治疗，并描述单独使用芬戈莫德或在 GA 或 IFN-β 治疗后的 RRMS 患者中可能的免疫生物标志物。材料和方法 这是一项对照、非随机临床试验。在为期一年的随访中，评估了两组患者的 IL-31、sCD40L 和其他九种细胞因子的血浆浓度。第 1 组 (n = 12)：在研究前至少接受 GA 或 IFN-β 治疗 6 个月的 RRMS 患者，6 个月后改为芬戈莫德治疗；第 2 组 (n = 12)：首次接受 GA 或 IFN-β 治疗的 RRMS 患者芬戈莫德。我们使用ANOVA双向分析细胞因子和Spearman系数来评估相关性。结果 尽管第 2 组开始时每个疾病持续时间的复发次数较多，但芬戈莫德治疗可有效降低该参数以及 12 个月内的 EDSS。然而，第 1 组的 GA 或 IFN-β 治疗显示出 6 个月随访后复发次数增加的趋势，而当治疗改为芬戈莫德时，复发次数减少。 在一年内对 11 种细胞因子进行评估后，我们发现 IL-31 和 sCD40L 是与经典生物标志物相比表现出更大差异的生物标志物，遵循治疗期间的临床模式。结论 我们的研究描述了两种有前途的血浆生物标志物（IL-31 和 sCD40L）的存在，它们在芬戈莫德治疗时间后降低了 RRMS 患者的血浆水平，尽管需要更多的研究来证明其有效性。