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
{"title":"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","authors":"Gary Cutter,&nbsp;Richard A Rudick,&nbsp;Carl de Moor,&nbsp;Carol M Singh,&nbsp;Elizabeth Fisher,&nbsp;Thijs Koster,&nbsp;Fred D Lublin,&nbsp;Jerry S Wolinsky,&nbsp;Henry McFarland,&nbsp;Steven Jacobson,&nbsp;Maria L Naylor","doi":"10.1177/20552173231169463","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>This analysis investigated changes in serum neurofilament light-chain (sNfL) levels in response to treatment and assessed baseline sNfL as a predictor of relapse.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/30/f5/10.1177_20552173231169463.PMC10150429.pdf","citationCount":"1","resultStr":"{\"title\":\"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.\",\"authors\":\"Gary Cutter,&nbsp;Richard A Rudick,&nbsp;Carl de Moor,&nbsp;Carol M Singh,&nbsp;Elizabeth Fisher,&nbsp;Thijs Koster,&nbsp;Fred D Lublin,&nbsp;Jerry S Wolinsky,&nbsp;Henry McFarland,&nbsp;Steven Jacobson,&nbsp;Maria L Naylor\",\"doi\":\"10.1177/20552173231169463\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>This analysis investigated changes in serum neurofilament light-chain (sNfL) levels in response to treatment and assessed baseline sNfL as a predictor of relapse.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":18961,\"journal\":{\"name\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2023-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/30/f5/10.1177_20552173231169463.PMC10150429.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Multiple Sclerosis Journal - Experimental, Translational and Clinical\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/20552173231169463\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/20552173231169463","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
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.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1