复发缓解型多发性硬化症患者血清神经丝轻链水平和长期治疗结果:随机CombiRx试验的事后分析

Gary Cutter, Richard A Rudick, Carl de Moor, Carol M Singh, Elizabeth Fisher, Thijs Koster, Fred D Lublin, Jerry S Wolinsky, Henry McFarland, Steven Jacobson, Maria L Naylor
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引用次数: 1

摘要

背景:CombiRx是一项随机、双盲、安慰剂对照的3期试验,研究对象是首次接受治疗的复发-缓解型多发性硬化症(RRMS)患者,随机接受肌肉注射干扰素β -1a (IM IFN β -1a)、醋酸格拉替默(GA)或两种治疗。目的:本分析研究了治疗后血清神经丝轻链(sNfL)水平的变化,并评估了基线sNfL作为复发的预测因子。方法:纳入IM IFN β -1a每周30µg +安慰剂(n = 159)、GA每天20 mg/mL +安慰剂(n = 172)或IM IFN β -1a + GA (n = 344)治疗的RRMS患者。线性混合模型比较了sNfL值随时间的变化。Cox回归模型分析了基线sNfL和钆增强(Gd+)病变作为复发的预测因子。结果:在所有治疗组中,sNfL≥16pg /mL的患者比例从基线到6个月显著下降,并维持在36个月。与sNfL患者相比,基线sNfL≥16 pg/mL和≥1 Gd+病变的患者在90天内复发的比例明显更高。结论:sNfL水平在6个月内降低,并在36个月时保持低水平。结果表明,病灶活动性和sNfL的结合比单独的任何因素都更能预测复发。
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Serum neurofilament light-chain levels and long-term treatment outcomes in relapsing-remitting multiple sclerosis patients: A post hoc analysis of the randomized CombiRx trial.

Background: CombiRx was a randomized, double-blind, placebo-controlled phase 3 trial in treatment-naive relapsing-remitting multiple sclerosis (RRMS) patients randomized to intramuscular interferon beta-1a (IM IFN beta-1a), glatiramer acetate (GA), or both therapies.

Objective: This analysis investigated changes in serum neurofilament light-chain (sNfL) levels in response to treatment and assessed baseline sNfL as a predictor of relapse.

Methods: RRMS patients treated with IM IFN beta-1a 30 µg weekly + placebo (n = 159), GA 20 mg/mL daily + placebo (n = 172), or IM IFN beta-1a + GA (n = 344) were included. A linear mixed model compared sNfL values over time. Cox regression models analyzed baseline sNfL and gadolinium-enhancing (Gd+) lesions as predictors of relapse.

Results: In all treatment arms, the proportion of patients with sNfL ≥16 pg/mL decreased significantly from baseline to 6 months and was maintained at 36 months. A significantly higher percentage of patients with both baseline sNfL ≥16 pg/mL and ≥1 Gd+ lesion experienced relapses within 90 days compared to patients with sNfL <16 pg/mL and/or no Gd+ lesions.

Conclusion: sNfL levels were reduced within 6 months and remained low at 36 months. Results suggest that the combination of lesion activity and sNfL was a stronger predictor of relapse than either factor alone.

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来源期刊
CiteScore
4.70
自引率
0.00%
发文量
54
审稿时长
15 weeks
期刊最新文献
Cannabinoids for spasticity in patients with multiple sclerosis: A systematic review and meta-analysis. Treatment effect modifiers of immunotherapies for relapsing-remitting multiple sclerosis-A systematic review and meta-analysis. Cesarian sections in women with multiple sclerosis: A Canadian prospective pregnancy study. Exploring the relationship between neurologists and older persons with multiple sclerosis through the lens of social support theory. Illness representation in patients with multiple sclerosis: A preliminary narrative medicine study.
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