Neurology Department, Hospital Universitario Ramón y Cajal, La Red Española de Esclerosis Multiple, Red de Enfermedades Inflamatorias, Instituto de Salud Carlos III (ISCIII), Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
Immunology Department, Hospital Universitario Ramón y Cajal, La Red Española de Esclerosis Multiple, Red de Enfermedades Inflamatorias, Instituto de Salud Carlos III, Instituto Ramón y Cajal de Investigación Sanitaria, Madrid, Spain.
Front Immunol. 2024 Aug 19;15:1454474. doi: 10.3389/fimmu.2024.1454474. eCollection 2024.
Alemtuzumab is a highly effective pulsed immune reconstitution therapy for multiple sclerosis (MS).
To evaluate serum neurofilament light chain (sNfL) and serum glial fibrillary acidic protein (sGFAP) in patients with relapsing-remitting MS who have been treated with Alemtuzumab over the course of 2 years.
This prospective study involved MS patients treated with Alemtuzumab at a referral MS center. Both sNfL and sGFAP were analyzed at baseline and then again at 6, 12, and 24 months post-treatment using the single molecule array (SiMoA) technique. We also recruited matched healthy controls (HCs) for comparison.
The study included 46 patients (with a median age of 34.2 [Interquartile range (IQR), 28.7-42.3] years, 27 of which were women [58%]) and 76 HCs. No differences in demographic characteristics were observed between patients and HC. The median disease duration was 6.22 (IQR, 1.56-10.13) years. The median annualized relapse rate before treatment was 2 (IQR, 1-3). At baseline, sNfL and sGFAP levels were higher in MS patients (median of 18.8 [IQR, 10.7-52.7] pg/ml and 158.9 [IQR, 126.9-255.5] pg/ml, respectively) when compared to HC (6.11 [IQR, 2.03-8.54] pg/ml and 91.0 [72.6-109] pg/ml, respectively) (p<0.001 for both comparisons). The data indicates that 80% of patients had high (≥10 pg/ml) sNfL values at baseline. We observed a significant decrease in sNfL levels at 6 (65%, p = 0.02), 12 (70.8%, p<0.001), and 24 (78.1%, p<0.001) months. sNfL reached similar levels to HC only after 24 months of Alemtuzumab treatment. During the follow-up period, no changes were identified in the sGFAP values.
Alemtuzumab leads to the normalization of sNfL values in MS patients after 2 years of treatment, with no apparent effect on sGFAP values.
阿仑单抗是一种用于多发性硬化症(MS)的高效脉冲免疫重建疗法。
评估接受阿仑单抗治疗的复发缓解型 MS 患者在 2 年内的血清神经丝轻链(sNfL)和血清神经胶质纤维酸性蛋白(sGFAP)水平。
本前瞻性研究纳入了在转诊 MS 中心接受阿仑单抗治疗的 MS 患者。使用单分子阵列(SiMoA)技术,在基线时以及治疗后 6、12 和 24 个月时,分别分析 sNfL 和 sGFAP。我们还招募了匹配的健康对照者(HCs)进行比较。
该研究纳入了 46 名患者(中位年龄 34.2 [四分位间距(IQR),28.7-42.3] 岁,其中 27 名为女性[58%])和 76 名 HCs。患者和 HCs 的人口统计学特征无差异。中位疾病持续时间为 6.22(IQR,1.56-10.13)年。治疗前的中位年化复发率为 2(IQR,1-3)。基线时,MS 患者的 sNfL 和 sGFAP 水平更高(中位数分别为 18.8(IQR,10.7-52.7)pg/ml 和 158.9(IQR,126.9-255.5)pg/ml),与 HCs(中位数分别为 6.11(IQR,2.03-8.54)pg/ml 和 91.0(72.6-109)pg/ml)相比,差异均具有统计学意义(p<0.001)。数据表明,80%的患者在基线时 sNfL 值较高(≥10pg/ml)。我们观察到治疗 6(65%,p=0.02)、12(70.8%,p<0.001)和 24(78.1%,p<0.001)个月后 sNfL 水平显著降低。仅在接受阿仑单抗治疗 24 个月后,sNfL 才达到与 HCs 相似的水平。在随访期间,sGFAP 值无变化。
阿仑单抗治疗 2 年后,MS 患者的 sNfL 值恢复正常,sGFAP 值无明显变化。