Department of Neurology, Pavol Jozef Šafárik University, Košice, Slovakia.
Department of Health Psychology and Methodology of Research, II. Internal clinic, Pavol Jozef Šafárik University, Košice, Slovakia.
Eur Neurol. 2021;84(4):272-279. doi: 10.1159/000515806. Epub 2021 May 25.
There is a need for blood biomarkers of disease activity in multiple sclerosis (MS). The aim of the study was to assess the relationship between plasma neurofilament light chain (pNfL) and disease activity as defined by the concept three-domain no evident disease activity (NEDA-3).
Levels of pNfL (SIMOA) were examined in 159 MS patients and analyzed in relationship to NEDA-3 status (absence of relapse, disability score worsening, and brain magnetic resonance activity) during the last 12 months. The accuracy of the proposed model was evaluated by calculating the area under the receiver operating characteristics (ROC) curve. From the pNfL cutoff, we evaluated the NEDA-NfL status (no relapse, no Expanded Disability Status Scale [EDSS] worsening, and pNfL below the cutoff value).
Levels of pNfL were significantly higher in MS patients than in healthy controls (p < 0.001). From a total of 159 patients, 80 (50.3%) achieved NEDA-3 status, while 79 (49.7%) patients showed evident disease activity (EDA) status. pNfL were significantly lower in the NEDA-3 group than in the EDA group (pNfL mean 7.06 pg/mL [standard deviation (SD) 2.37] vs. pNfL mean 13.04 pg/mL [SD 7.07]) (p < 0.001). ROC analysis showed that pNfL predicts NEDA-3 status (sensitivity and specificity were 80.5 and 72.7%, respectively, p < 0.001), and NEDA-NfL predicts NEDA-3 status (sensitivity and specificity were 97.1 and 82.9%, respectively, p < 0.001).
The results show that pNfL levels are a useful biomarker of disease activity determined by NEDA status in patients with MS and could be an alternative to brain magnetic resonance investigation.
多发性硬化症（MS）患者需要血液生物标志物来反映疾病活动度。本研究旨在评估血浆神经丝轻链（pNfL）与根据无明显疾病活动（NEDA-3）概念定义的疾病活动之间的关系。
在 159 名 MS 患者中检测了 pNfL（SIMOA）水平，并将其与过去 12 个月的 NEDA-3 状态（无复发、残疾评分恶化和脑磁共振活动）进行了分析。通过计算受试者工作特征曲线（ROC）下的面积来评估所提出模型的准确性。从 pNfL 截值，我们评估了 NEDA-NfL 状态（无复发、无扩展残疾状态量表 [EDSS]恶化和 pNfL 值低于截值）。
MS 患者的 pNfL 水平明显高于健康对照组（p<0.001）。在总共 159 名患者中，80 名（50.3%）达到了 NEDA-3 状态，而 79 名（49.7%）患者表现出明显的疾病活动（EDA）状态。NEDA-3 组的 pNfL 明显低于 EDA 组（pNfL 平均值 7.06 pg/mL [标准差（SD）2.37] vs. pNfL 平均值 13.04 pg/mL [SD 7.07]）（p<0.001）。ROC 分析表明，pNfL 可预测 NEDA-3 状态（敏感性和特异性分别为 80.5%和 72.7%，p<0.001），而 NEDA-NfL 可预测 NEDA-3 状态（敏感性和特异性分别为 97.1%和 82.9%，p<0.001）。
研究结果表明，pNfL 水平是 MS 患者通过 NEDA 状态确定的疾病活动的有用生物标志物，可作为脑磁共振检查的替代方法。
