Abstract：
OBJECTIVE: Blood neurofilament light chain (NfL) is robustly associated with disease worsening in multiple sclerosis (MS), though potentially affected by concomitant factors also determining neuro-axonal loss. We investigated the association between plasma NfL (pNfL) measured with Lumipulse™ immunoassay and demographic and clinical variables in MS.
METHODS: This cross-sectional study included 685 people with MS (age 49.7 ± 12.4 years; sex 65.55% females). On the same day, we collected plasma samples, along with demographics, comorbidities, and clinical variables (MS disease duration, expanded disability status scale (EDSS), Symbol Digit Modalities Test (SDMT), descriptor of disease progression, current disease modifying treatment (DMT), number of previous DMTs, evidence of disease activity in the past year (i.e. relapse or MRI new lesions), EDSS progression). pNfL was evaluated using Lumipulse™ fully automated chemiluminescent enzyme immunoassay.
RESULTS: On multivariable linear regression model, higher pNfL was associated with higher EDSS (Coeff = 1.73; 95%CI 0.78, 2.68; p < 0.01), recent disease activity (Coeff = 15.70; 95%CI = 5.35, 26.06; p < 0.01), and presence of cardiovascular comorbidity (Coeff = 3.84; 95%CI 0.48, 7.20; p = 0.025). Lower pNfL was found in patients on DMT treatment (Coeff = -10.23; 95%CI -18.42, -2.04; p = 0.015), when compared with no DMT (reference). For 77.81% of our population there was correspondence between pNfL levels and two previously-validated cutoffs.
CONCLUSIONS: pNfL measured using Lumipulse™ confirms known associations with MS activity, disability and treatments, and related confounding (e.g., cardiovascular comorbidity), thus granting further utilization in research and clinical practice.
METHODS: This cross-sectional study included 685 people with MS (age 49.7 ± 12.4 years; sex 65.55% females). On the same day, we collected plasma samples, along with demographics, comorbidities, and clinical variables (MS disease duration, expanded disability status scale (EDSS), Symbol Digit Modalities Test (SDMT), descriptor of disease progression, current disease modifying treatment (DMT), number of previous DMTs, evidence of disease activity in the past year (i.e. relapse or MRI new lesions), EDSS progression). pNfL was evaluated using Lumipulse™ fully automated chemiluminescent enzyme immunoassay.
RESULTS: On multivariable linear regression model, higher pNfL was associated with higher EDSS (Coeff = 1.73; 95%CI 0.78, 2.68; p < 0.01), recent disease activity (Coeff = 15.70; 95%CI = 5.35, 26.06; p < 0.01), and presence of cardiovascular comorbidity (Coeff = 3.84; 95%CI 0.48, 7.20; p = 0.025). Lower pNfL was found in patients on DMT treatment (Coeff = -10.23; 95%CI -18.42, -2.04; p = 0.015), when compared with no DMT (reference). For 77.81% of our population there was correspondence between pNfL levels and two previously-validated cutoffs.
CONCLUSIONS: pNfL measured using Lumipulse™ confirms known associations with MS activity, disability and treatments, and related confounding (e.g., cardiovascular comorbidity), thus granting further utilization in research and clinical practice.
摘要：
目的：血液神经丝轻链（NfL）与多发性硬化症（MS）的疾病恶化密切相关，尽管可能受到伴随因素的影响，也决定了神经轴突丢失。我们调查了用Lumipulse™免疫测定法测定的血浆NfL（pNfL）与MS的人口统计学和临床变量之间的关联。
方法：这项横断面研究包括685名MS患者（年龄49.7±12.4岁；性别为65.55％女性）。在同一天,我们采集了血浆样本,随着人口统计学，合并症,和临床变量(MS疾病持续时间，扩展残疾状况量表(EDSS)，符号数字模式测试(SDMT),疾病进展描述符，当前的疾病改善治疗（DMT），以前的DMT的数量，过去一年疾病活动的证据（即复发或MRI新病变），EDSS进展）。使用Lumipulse™全自动化学发光酶免疫测定来评估pNfL。
结果：关于多元线性回归模型，较高的pNfL与较高的EDSS相关(Coeff=1.73；95CI0.78，2.68；p<0.01)，近期疾病活动（Coeff=15.70；95CI=5.35，26.06；p<0.01），和心血管合并症的存在（Coeff=3.84；95CI0.48，7.20；p=0.025）。在接受DMT治疗的患者中发现pNfL较低（Coeff=-10.23；95CI-18.42，-2.04；p=0.015），当与没有DMT（参考）相比。对于77.81％的人口，pNfL水平与两个先前验证的截止值之间存在对应关系。
结论：使用Lumipulse™测量的pNfL证实了与MS活性的已知关联，残疾和治疗，和相关的混杂因素(例如，心血管合并症)，从而在研究和临床实践中给予进一步的利用。
方法：这项横断面研究包括685名MS患者（年龄49.7±12.4岁；性别为65.55％女性）。在同一天,我们采集了血浆样本,随着人口统计学，合并症,和临床变量(MS疾病持续时间，扩展残疾状况量表(EDSS)，符号数字模式测试(SDMT),疾病进展描述符，当前的疾病改善治疗（DMT），以前的DMT的数量，过去一年疾病活动的证据（即复发或MRI新病变），EDSS进展）。使用Lumipulse™全自动化学发光酶免疫测定来评估pNfL。
结果：关于多元线性回归模型，较高的pNfL与较高的EDSS相关(Coeff=1.73；95CI0.78，2.68；p<0.01)，近期疾病活动（Coeff=15.70；95CI=5.35，26.06；p<0.01），和心血管合并症的存在（Coeff=3.84；95CI0.48，7.20；p=0.025）。在接受DMT治疗的患者中发现pNfL较低（Coeff=-10.23；95CI-18.42，-2.04；p=0.015），当与没有DMT（参考）相比。对于77.81％的人口，pNfL水平与两个先前验证的截止值之间存在对应关系。
结论：使用Lumipulse™测量的pNfL证实了与MS活性的已知关联，残疾和治疗，和相关的混杂因素(例如，心血管合并症)，从而在研究和临床实践中给予进一步的利用。
