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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. 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
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-04-01 DOI: 10.1177/20552173231169463
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

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.

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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引用次数: 1
Severity and worsening of fatigue among individuals with multiple sclerosis. 多发性硬化症患者疲劳的严重程度和恶化程度。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-04-01 DOI: 10.1177/20552173231167079
Amber Salter, Alexander Keenan, Hoa H Le, Kavita Gandhi, Maria Ait-Tihyaty, Samantha Lancia, Gary R Cutter, Robert J Fox, Ruth Ann Marrie

Background: Fatigue is associated with reduced quality of life and social participation, and poor employment outcomes. However, most studies examining fatigue are limited by small sample sizes or short follow-up periods.

Objective: To characterize the natural history of fatigue.

Methods: The North American Research Committee on Multiple Sclerosis Registry participants with ≥7 years of longitudinal data between 2004 and 2019 and a relapsing disease course were included. A subset of participants enrolled within 5 years of diagnosis was identified. The Fatigue Performance Scale assessed fatigue and ≥1-point increase in Fatigue Performance Scale sustained at the next survey defined fatigue worsening.

Results: Of 3057 participants with longitudinal data, 944 were within 5 years of multiple sclerosis diagnosis. Most participants (52%) reported fatigue worsening during follow-up. Median time to fatigue worsening ranged from 3.5 to 5 years at lower levels of index fatigue. Fatigue worsening was associated with lower annual income, increasing disability, lower initial fatigue level, taking injectable disease-modifying therapies and increasing depression levels in the relapsing multiple sclerosis participants.

Conclusion: Most multiple sclerosis participants early in their disease suffer from fatigue and at least half reported fatigue worsening over time. Understanding factors associated with fatigue may help to identify populations most at risk of fatigue worsening will be informative for the overall management of patients with multiple sclerosis.

背景:疲劳与生活质量和社会参与度降低以及就业结果不佳有关。然而,大多数关于疲劳的研究都受到样本量小或随访时间短的限制。目的:了解疲劳的自然病程。方法:纳入北美多发性硬化症研究委员会登记的2004年至2019年纵向数据≥7年且病程复发的参与者。确定了在诊断5年内入组的参与者子集。疲劳性能量表评估疲劳和≥1点的疲劳性能量表持续在下一次调查定义疲劳恶化。结果:在3057名参与者的纵向数据中,944人在多发性硬化症诊断的5年内。大多数参与者(52%)报告在随访期间疲劳加重。在指数疲劳较低的情况下,疲劳恶化的中位时间为3.5至5年。在复发性多发性硬化症参与者中,疲劳恶化与年收入降低、残疾增加、初始疲劳水平降低、服用可注射的疾病改善疗法和抑郁水平增加有关。结论:大多数多发性硬化症的早期参与者都有疲劳症状,至少一半的人报告疲劳随着时间的推移而恶化。了解与疲劳相关的因素可能有助于确定疲劳恶化风险最大的人群,这将为多发性硬化症患者的整体管理提供信息。
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引用次数: 0
Multiple sclerosis health-related quality of life utility values from the UK MS register. 来自英国多发性硬化症登记册的多发性硬化症与健康相关的生活质量效用值。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-04-01 DOI: 10.1177/20552173231178441
A Heather, E Goodwin, C Green, N Morrish, O C Ukoumunne, R M Middleton, A Hawton

Background: New interventions for multiple sclerosis (MS) commonly require a demonstration of cost-effectiveness using health-related quality of life (HRQoL) utility values. The EQ-5D is the utility measure approved for use in the UK NHS funding decision-making. There are also MS-specific utility measures - e.g., MS Impact Scale Eight Dimensions (MSIS-8D) and MSIS-8D-Patient (MSIS-8D-P).

Objectives: Provide EQ-5D, MSIS-8D and MSIS-8D-P utility values from a large UK MS cohort and investigate their association with demographic/clinical characteristics.

Methods: UK MS Register data from 14,385 respondents (2011 to 2019) were analysed descriptively and using multivariable linear regression, with self-report Expanded Disability Status Scale (EDSS) scores.

Results: The EQ-5D and MSIS-8D were both sensitive to differences in demographic/clinical characteristics. An inconsistency found in previous studies whereby mean EQ-5D values were higher for an EDSS score of 4 rather than 3 was not observed. Similar utility values were observed between MS types at each EDSS score. Regression showed EDSS score and age were associated with utility values from all three measures.

Conclusions: This study provides generic and MS-specific utility values for a large UK MS sample, with the potential for use in cost-effectiveness analyses of treatments for MS.

背景:多发性硬化症(MS)的新干预措施通常需要使用与健康相关的生活质量(HRQoL)效用值来证明成本效益。EQ-5D是批准用于英国国民保健服务资助决策的实用措施。还有MS特定的效用测量-例如,MS影响量表八维度(MSIS-8D)和MSIS-8D-患者(MSIS-8D- p)。目的:从英国一个大型MS队列中提供EQ-5D、MSIS-8D和MSIS-8D- p的效用值,并调查它们与人口统计学/临床特征的关系。方法:采用多变量线性回归和自我报告的扩展残疾状态量表(EDSS)评分,对2011年至2019年14385名受访者的英国MS Register数据进行描述性分析。结果:EQ-5D和MSIS-8D对人口统计学/临床特征的差异都很敏感。在先前的研究中没有发现不一致的现象,即EDSS评分为4而不是3的平均EQ-5D值更高。在每个EDSS评分中,MS类型之间观察到相似的效用值。回归显示EDSS评分和年龄与所有三项测量的效用值相关。结论:该研究为英国大型多发性硬化症样本提供了通用和多发性硬化症特异性实用价值,具有用于多发性硬化症治疗的成本效益分析的潜力。
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引用次数: 0
Preserved T cell but attenuated antibody response in MS patients on fingolimod and ocrelizumab following 2nd and 3rd SARS-CoV-2 mRNA vaccine. 在第二次和第三次SARS-CoV-2 mRNA疫苗接种后,MS患者使用fingolimod和ocrelizumab保留T细胞,但抗体反应减弱。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-04-01 DOI: 10.1177/20552173231165196
Sarah Conway, Shrishti Saxena, Clare Baecher-Allan, Rajesh Krishnan, Maria Houtchens, Bonnie Glanz, Taylor J Saraceno, Mariann Polgar-Turcsanyi, Gauruv Bose, Rohit Bakshi, Shamik Bhattacharyya, Kristin Galetta, Tamara Kaplan, Christopher Severson, Tarun Singhal, Lynn Stazzone, Jonathan Zurawski, Anu Paul, Howard L Weiner, Brian C Healy, Tanuja Chitnis

Background: There is limited knowledge about T cell responses in patients with multiple sclerosis (MS) after 3 doses of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccine.

Objectives: Assess the SARS-CoV-2 spike antibody and T cell responses in MS patients and healthy controls (HCs) after 2 doses (2-vax) and 3 doses (3-vax) of SARS-CoV-2 mRNA vaccination.

Methods: We studied seroconversion rates and T cell responses by flow cytometry in HC and MS patients on fingolimod or ocrelizumab.

Results: After 2-vax, 8/33 (24.2%) patients in ocrelizumab group, 5/7 (71.4%) in fingolimod group, and 29/29 (100%) in HC group (P = 5.7 × 10-11) seroconverted. After 3-vax, 9/22 (40.9%) patients in ocrelizumab group, 19/21 (90.5%) in fingolimod group, and 7/7 (100%) in HC group seroconverted (P = 0.0003). The percentage of SARS-CoV-2 peptide reactive total CD4+ T cells increased in HC and ocrelizumab group but not in fingolimod group after 2-vax and 3-vax (P < 0.0001). The percentage of IFNγ and TNFα producing total CD4+ and CD8+ T cells increased in fingolimod group as compared to HC and ocrelizumab group after 2-vax and 3-vax (P < 0.0001).

Conclusions: MS patients on ocrelizumab and fingolimod had attenuated humoral responses, but preserved cytokine producing T cell responses compared to HCs after SARS-CoV-2 mRNA vaccination.

Clinical trials registration: NCT05060354.

背景:对3剂严重急性呼吸综合征冠状病毒2 (SARS-CoV-2) mRNA疫苗后多发性硬化症(MS)患者T细胞反应的了解有限。目的:评估2剂(2-vax)和3剂(3-vax) SARS-CoV-2 mRNA疫苗接种后MS患者和健康对照(hc)的SARS-CoV-2刺突抗体和T细胞反应。方法:采用流式细胞术研究芬戈莫德或奥克雷单抗治疗的HC和MS患者血清转化率和T细胞反应。结果:2-vax后,ocrelizumab组8/33例(24.2%),fingolimod组5/7例(71.4%),HC组29/29例(100%)血清转化(P = 5.7 × 10-11)。3-vax后,ocrelizumab组9/22(40.9%)、fingolimod组19/21(90.5%)、HC组7/7(100%)的患者血清转化(P = 0.0003)。2-vax和3-vax后,HC组和奥克雷珠单抗组的SARS-CoV-2肽反应性总CD4+ T细胞百分比增加,而芬戈莫德组则没有(P P)结论:与接种SARS-CoV-2 mRNA疫苗后的HC相比,奥克雷珠单抗和芬戈莫德组的MS患者的体液反应减弱,但细胞因子产生的T细胞反应保留。临床试验注册:NCT05060354。
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引用次数: 4
Detecting disability using self-reported and clinical assessments in early-stage relapsing-remitting multiple sclerosis: Looking for a complementary approach. 在早期复发缓解型多发性硬化症中使用自我报告和临床评估来检测残疾:寻找一种补充方法。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-04-01 DOI: 10.1177/20552173231169475
Susana Sainz de la Maza, Rocío Gómez-Ballesteros, Mónica Borges, Jesús Martín-Martínez, Javier Sotoca, Ana Alonso, Ana B Caminero, Laura Borrega, José L Sánchez-Menoyo, Francisco J Barrero-Hernández, Carmen Calles, Luis Brieva, María R Blasco-Quílez, Julio Dotor García-Soto, María Del Campo-Amigo, Laura Navarro-Cantó, Eduardo Agüera, Moisés Garcés-Redondo, Olga Carmona, Laura Gabaldón-Torres, Lucía Forero, Mariona Hervàs, Nicolás Medrano, Jorge Maurino, Tamara Castillo-Triviño

Disability accrual is mainly driven by progression independent of relapse activity, which is present even in early stages of relapsing-remitting multiple sclerosis (RRMS) and sometimes overlooked. This multicenter, non-interventional study evaluated whether patient-reported outcomes measures (PROMs) could capture disability in 189 early-stage RRMS patients (mean age: 36.1 ± 9.4 years, 71.4% female, mean disease duration: 1.4 ± 0.8 years, median EDSS: 1.0). The 9-Hole Peg Test (9-HPT), NeuroQoL Upper Extremity (NeuroQoL-UE), Timed 25-Foot Walk (T25-FW), Multiple Sclerosis Walking Scale (MSWS-12), Symbol Digit Modalities Test (SDMT), and Perceived Deficits Questionnaire (PDQ-5) were used to assess hand function, gait, and cognition, respectively. These functions were at least mildly affected in this early-stage population, finding significant correlations between PROMs and clinical assessments. PROMs could enable early-stage RRMS patients to communicate their perceived disability in different domains, assisting clinicians in disease monitoring and decision making.

残疾的增加主要是由独立于复发活动的进展驱动的,即使在复发缓解型多发性硬化症(RRMS)的早期阶段也存在,有时被忽视。这项多中心、非介入性研究评估了189例早期RRMS患者(平均年龄:36.1±9.4岁,71.4%为女性,平均病程:1.4±0.8年,中位EDSS: 1.0)的患者报告结局测量(PROMs)是否可以捕获残疾。采用9孔Peg测试(9-HPT)、NeuroQoL上肢(NeuroQoL- ue)、25英尺步行时间(T25-FW)、多发性硬化症步行量表(MSWS-12)、符号数字形态测试(SDMT)和感知缺陷问卷(PDQ-5)分别评估了手功能、步态和认知。在这些早期人群中,这些功能至少受到轻微影响,发现PROMs与临床评估之间存在显著相关性。PROMs可以使早期RRMS患者在不同领域交流他们感知到的残疾,帮助临床医生进行疾病监测和决策。
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引用次数: 0
Axonal and myelin changes and their inter-relationship in the optic radiations in people with multiple sclerosis. 多发性硬化症患者视辐射中轴突和髓鞘的变化及其相互关系。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-02-16 eCollection Date: 2023-01-01 DOI: 10.1177/20552173221147620
Eva A Krijnen, Chanon Ngamsombat, Ilena C George, Fang F Yu, Qiuyun Fan, Qiyuan Tian, Susie Y Huang, Eric C Klawiter

Background: The imaging g-ratio, estimated from axonal volume fraction (AVF) and myelin volume fraction (MVF), is a novel biomarker of microstructural tissue integrity in multiple sclerosis (MS).

Objective: To assess axonal and myelin changes and their inter-relationship as measured by g-ratio in the optic radiations (OR) in people with MS (pwMS) with and without previous optic neuritis (ON) compared to healthy controls (HC).

Methods: Thirty pwMS and 17 HCs were scanned on a 3Tesla Connectom scanner. AVF and MVF, derived from a multi-shell diffusion protocol and macromolecular tissue volume, respectively, were measured in normal-appearing white matter (NAWM) and lesions within the OR and used to calculate imaging g-ratio.

Results: OR AVF and MVF were decreased in pwMS compared to HC, and in OR lesions compared to NAWM, whereas the g-ratio was not different. Compared to pwMS with previous ON, AVF and g-ratio tended to be higher in pwMS without prior ON. AVF and MVF, particularly in NAWM, were positively correlated with retinal thickness, which was more pronounced in pwMS with prior ON.

Conclusion: Axonal measures reflect microstructural tissue damage in the OR, particularly in the setting of remote ON, and correlate with established metrics of visual health in MS.

背景:根据轴突体积分数(AVF)和髓鞘体积分数(MVF)估计的成像g比率是多发性硬化症(MS)微观结构组织完整性的一种新的生物标志物。目的:与健康对照组(HC)相比,评估有和无视神经炎(ON)的MS患者(pwMS)的轴突和髓鞘变化及其相互关系。方法:在3Tesla-Connectom扫描仪上对30个pwMS和17个HC进行扫描。AVF和MVF分别来源于多壳扩散方案和大分子组织体积,在正常出现的白质(NAWM)和OR内的病变中进行测量,并用于计算成像g-ratio。结果:与HC相比,pwMS的OR AVF和MVF降低,与NAWM相比,OR病变的OR AVF。与有既往ON的pwMS相比,没有既往ON的pwMS的AVF和g比率往往更高。AVF和MVF,特别是在NAWM中,与视网膜厚度呈正相关,这在有既往ON时更为明显。结论:轴索测量反映了OR中的微结构组织损伤,尤其是在远程ON的情况下,并与MS中视觉健康的已建立的指标相关。
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引用次数: 0
Intravenous immunoglobulin treatment during pregnancy and the post-partum period in women with multiple sclerosis: A prospective analysis. 妊娠期和产后静脉注射免疫球蛋白治疗多发性硬化症:一项前瞻性分析
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-01-01 DOI: 10.1177/20552173221151127
Shay Menascu, Michal Siegel-Kirshenbaum, Sapir Dreyer-Alster, Yehuda Warszawer, David Magalashvili, Mark Dolev, Mathilda Mandel, Gil Harari, Anat Achiron

Background: Relapsing-remitting multiple sclerosis (RRMS) affects predominantly young women within reproductive years. As an increased risk of relapses is known to occur during the post-partum period, it is important to consider treatment options.

Aim: Evaluate the effects of intravenous immunoglobulins (IVIg) to prevent post-partum relapses.

Methods: We prospectively followed 198 pregnant female RRMS patients, 67 treated with IVIg during pregnancy and the three months post-partum, and 131 untreated patients that served as controls.

Results: During the pre-gestation year, 41.4% were treated with immunomodulatory drugs, and 28.3% experienced a relapse. During pregnancy and the post-partum period, the number of relapsing patients significantly decreased in the IVIg group (37.3%, 10.4%, 8.9%, respectively, p = 0.0003), while no significant change was observed in the untreated group (23.7%, 17.6%, and 22.1%). During the three-month post-partum period, there were only mild and moderate relapses in the IVIg group, while in the untreated group, there were also severe relapses. Stepwise logistic regression that assessed the relation between three-month post-partum relapse and explanatory variables demonstrated that untreated patients had increased risk for post-partum relapse (odds ratio = 4.6, 95% CI [1.69, 12.78], p = 0.033).

Conclusions: IVIg treatment proved efficient to reduce the rate and severity of relapses during pregnancy and the three-month post-partum.

背景:复发缓解型多发性硬化症(RRMS)主要影响育龄期的年轻女性。由于已知在产后期间复发的风险增加,因此考虑治疗方案很重要。目的:评价静脉注射免疫球蛋白(IVIg)预防产后复发的效果。方法:对198例妊娠期女性RRMS患者进行前瞻性随访,其中67例在妊娠期及产后3个月接受IVIg治疗,131例未接受IVIg治疗的患者作为对照。结果:孕前一年,41.4%的患者接受免疫调节药物治疗,28.3%的患者复发。在妊娠期和产后,IVIg组复发率显著降低(分别为37.3%、10.4%、8.9%,p = 0.0003),而未治疗组复发率无显著变化(分别为23.7%、17.6%、22.1%)。在产后3个月期间,IVIg组仅有轻、中度复发,而未治疗组也有重度复发。逐步logistic回归评估了产后3个月复发与解释变量之间的关系,结果显示未经治疗的患者产后复发的风险增加(优势比= 4.6,95% CI [1.69, 12.78], p = 0.033)。结论:IVIg治疗可有效降低妊娠期及产后3个月的复发率和严重程度。
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引用次数: 1
Impact of treatment with dimethyl fumarate on sleep quality in patients with relapsing-remitting multiple sclerosis: A multicentre Italian wearable tracker study. 富马酸二甲酯治疗对复发缓解型多发性硬化症患者睡眠质量的影响:一项多中心意大利可穿戴追踪器研究
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-01-01 DOI: 10.1177/20552173221144229
Giancarlo Comi, Letizia Leocani, Luigi Ferini-Strambi, Marta Radaelli, Gloria D Costa, Roberta Lanzillo, Giacomo Lus, Valentina Bianchi, Sebastiano Traccis, Fioravante Capone, Luigi Me Grimaldi, Giuseppe Salemi, Alessandra Cardillo, Valentina Zipoli

Background: Sleep disorders are common in patients with multiple sclerosis and have a bidirectional interplay with fatigue and depression.

Objective: To evaluate the effect of treatment with oral dimethyl fumarate on the quality of sleep in relapsing-remitting multiple sclerosis.

Methods: This was a multicentre observational study with 223 relapsing-remitting multiple sclerosis subjects starting treatment with dimethyl fumarate (n=177) or beta interferon (n=46). All patients underwent subjective (Pittsburgh Sleep Quality Index) and objective (wearable tracker) measurements of quality of sleep. Fatigue, depression, and quality of life were also investigated and physical activity was monitored.

Results: Patients treated with dimethyl fumarate had significant improvement in the quality of sleep as measured with the Pittsburgh Sleep Quality Index (p<0.001). At all-time points, no significant changes in Pittsburgh Sleep Quality Index score were observed in the interferon group. Total and deep sleep measured by wearable tracker decreased at week 12 with both treatments, then remained stable for the total study duration. Depression significantly improved in patients treated with dimethyl fumarate. No significant changes were observed in mobility, fatigue and quality of life.

Conclusion: In patients with relapsing-remitting multiple sclerosis, the treatment with dimethyl fumarate was associated with improvements in patient-reported quality of sleep. Further randomised clinical trials are needed to confirm the benefits of long-term treatment with dimethyl fumarate.

背景:睡眠障碍在多发性硬化症患者中很常见,并且与疲劳和抑郁有双向相互作用。目的:探讨口服富马酸二甲酯对复发缓解型多发性硬化症患者睡眠质量的影响。方法:这是一项多中心观察性研究,223名复发缓解型多发性硬化症患者开始接受富马酸二甲酯(n=177)或干扰素(n=46)治疗。所有患者均接受主观(匹兹堡睡眠质量指数)和客观(可穿戴跟踪器)睡眠质量测量。还调查了疲劳、抑郁和生活质量,并监测了身体活动。结果:用匹兹堡睡眠质量指数(匹兹堡睡眠质量指数)测量,富马酸二甲酯治疗的患者睡眠质量有显著改善。结论:在复发-缓解型多发性硬化症患者中,富马酸二甲酯治疗与患者报告的睡眠质量改善有关。需要进一步的随机临床试验来证实长期使用富马酸二甲酯治疗的益处。
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引用次数: 1
Achieving no evidence of disease activity-3 in highly active multiple sclerosis patients treated with cladribine and monoclonal antibodies. 在接受克拉德滨和单克隆抗体治疗的高活性多发性硬化症患者中,无疾病活动性-3的证据。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-01-01 DOI: 10.1177/20552173231154712
Ricardo Alonso, Magdalena Casas, Luciana Lazaro, Nora Fernandez Liguori, Cecilia Pita, Leila Cohen, Juan Ignacio Rojas, Agustín Pappolla, Liliana Patrucco, Edgardo Cristiano, Marcos Burgos, Carlos Vrech, Raul Piedrabuena, Lopez Pablo, Norma Deri, Geraldine Luetic, Jimena Miguez, Mariela Cabrera, Alejandra Martinez, Gisela Zanga, Verónica Tkachuk, Santiago Tizio, Edgar Carnero Contentti, Eduardo Knorre, Felisa Leguizamon, Carolina Mainella, Pedro Nofal, Susana Liwacki, Javier Hryb, Maria Menichini, Claudia Pestchanker, Marina Alonso, Orlando Garcea, Berenice Silva

Background: We aimed to determine the proportion of highly active multiple sclerosis patients under high-efficacy therapies (HETs) achieve no evidence of disease activity-3 (NEDA-3) at 1 and 2 years, and to identify factors associated with failing to meet no evidence of disease activity 3 at 2 years.

Methods: This retrospective cohort study based on Argentina Multiple Sclerosis patient registry (RelevarEM), includes highly active multiple sclerosis patients who received HETs.

Results: In total, 254 (78.51%) achieved NEDA-3 at year 1 and 220 (68.12%) achieved NEDA-3 at year 2. Patients who achieved NEDA-3 at 2 years had a shorter duration of multiple sclerosis (p < 0.01) and a shorter time between first treatment and current treatment (p = 0.01). Early high-efficacy strategy patients reached NEDA-3 more frequently (p < 0.01). Being a naïve patient (odds ratio: 3.78, 95% confidence interval 1.50-9.86, p < 0.01) was an independent predictor to reach NEDA-3 at 2 years. No association was found between type of HETs and NEDA-3 at 2 years when adjusted for potential confounders (odds ratio: 1.73; 95% confidence interval 0.51-6.06, p 0.57).

Conclusion: We found a high proportion of patients who achieved NEDA-3 at 1 and 2 years. Early high-efficacy strategy patients had a higher probability of achieving NEDA-3 at 2 years.

背景:我们的目的是确定在高效治疗(HETs)下,在1年和2年达到无疾病活动证据3 (NEDA-3)的高活性多发性硬化症患者的比例,并确定在2年未能达到无疾病活动证据3的相关因素。方法:本回顾性队列研究基于阿根廷多发性硬化症患者登记处(RelevarEM),包括接受HETs治疗的高度活跃的多发性硬化症患者。结果:254例(78.51%)患者在1年达到NEDA-3, 220例(68.12%)患者在2年达到NEDA-3。2年达到NEDA-3的患者多发性硬化症持续时间较短(p p = 0.01)。早期高效策略患者达到NEDA-3的频率更高(p < p < 0.57)。结论:我们发现在1年和2年达到NEDA-3的患者比例很高。早期高效策略患者在2年时达到NEDA-3的概率更高。
{"title":"Achieving no evidence of disease activity-3 in highly active multiple sclerosis patients treated with cladribine and monoclonal antibodies.","authors":"Ricardo Alonso,&nbsp;Magdalena Casas,&nbsp;Luciana Lazaro,&nbsp;Nora Fernandez Liguori,&nbsp;Cecilia Pita,&nbsp;Leila Cohen,&nbsp;Juan Ignacio Rojas,&nbsp;Agustín Pappolla,&nbsp;Liliana Patrucco,&nbsp;Edgardo Cristiano,&nbsp;Marcos Burgos,&nbsp;Carlos Vrech,&nbsp;Raul Piedrabuena,&nbsp;Lopez Pablo,&nbsp;Norma Deri,&nbsp;Geraldine Luetic,&nbsp;Jimena Miguez,&nbsp;Mariela Cabrera,&nbsp;Alejandra Martinez,&nbsp;Gisela Zanga,&nbsp;Verónica Tkachuk,&nbsp;Santiago Tizio,&nbsp;Edgar Carnero Contentti,&nbsp;Eduardo Knorre,&nbsp;Felisa Leguizamon,&nbsp;Carolina Mainella,&nbsp;Pedro Nofal,&nbsp;Susana Liwacki,&nbsp;Javier Hryb,&nbsp;Maria Menichini,&nbsp;Claudia Pestchanker,&nbsp;Marina Alonso,&nbsp;Orlando Garcea,&nbsp;Berenice Silva","doi":"10.1177/20552173231154712","DOIUrl":"https://doi.org/10.1177/20552173231154712","url":null,"abstract":"<p><strong>Background: </strong>We aimed to determine the proportion of highly active multiple sclerosis patients under high-efficacy therapies (HETs) achieve no evidence of disease activity-3 (NEDA-3) at 1 and 2 years, and to identify factors associated with failing to meet no evidence of disease activity 3 at 2 years.</p><p><strong>Methods: </strong>This retrospective cohort study based on Argentina Multiple Sclerosis patient registry (RelevarEM), includes highly active multiple sclerosis patients who received HETs.</p><p><strong>Results: </strong>In total, 254 (78.51%) achieved NEDA-3 at year 1 and 220 (68.12%) achieved NEDA-3 at year 2. Patients who achieved NEDA-3 at 2 years had a shorter duration of multiple sclerosis (<i>p</i> < 0.01) and a shorter time between first treatment and current treatment (<i>p</i> = 0.01). Early high-efficacy strategy patients reached NEDA-3 more frequently (<i>p</i> < 0.01). Being a naïve patient (odds ratio: 3.78, 95% confidence interval 1.50-9.86, <i>p</i> < 0.01) was an independent predictor to reach NEDA-3 at 2 years. No association was found between type of HETs and NEDA-3 at 2 years when adjusted for potential confounders (odds ratio: 1.73; 95% confidence interval 0.51-6.06, <i>p</i> 0.57).</p><p><strong>Conclusion: </strong>We found a high proportion of patients who achieved NEDA-3 at 1 and 2 years. Early high-efficacy strategy patients had a higher probability of achieving NEDA-3 at 2 years.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":"9 1","pages":"20552173231154712"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/29/18/10.1177_20552173231154712.PMC9950613.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9341901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Disease associations of excessive daytime sleepiness in multiple sclerosis: A prospective study. 多发性硬化症患者日间过度嗜睡与疾病的关系:一项前瞻性研究。
IF 2.8 Q2 CLINICAL NEUROLOGY Pub Date : 2023-01-01 DOI: 10.1177/20552173231159560
Peter V Sguigna, Sabeen Toranian, Lauren M Tardo, Kyle M Blackburn, Lindsay A Horton, Darrel Conger, Ethan Meltzer, R Nick Hogan, Morgan C McCreary, Phyllis C Zee, Joseph S Takahashi, Benjamin M Greenberg

Background: Excessive daytime sleepiness (EDS) in multiple sclerosis (MS) can be a significant source of disability. Despite this, its prevalence as a patient-reported outcome in this condition has not been well established, and its causes are not well understood.

Methods: We prospectively assessed EDS as part of an observational study for patients referred for diagnostic neuro-ophthalmological testing. EDS was evaluated by the Epworth Sleepiness Scale (ESS), and visual data were also collected as part of a research protocol. Analysis with patient data was performed following the exclusion of patients with known primary sleep disorders.

Results: A total of 69 patients with MS were included in the analysis. The mean ESS was 6.5 with a SD of 4.3. ESS ≥ 10 was present in 23% of the cohort even in the presence of minimal mean neurological disability (Patient Determined Disease Steps (PDDS) = 1.5). The ESS score was not associated with age, sex, disease-related disability, retinal nerve fiber layer (RNFL), or optic neuritis (ON), but displayed an association with visual dysfunction.

Conclusions: There is an increased prevalence of EDS in MS. The increased values of the ESS are not explained by other sleep disorders, suggesting separate mechanisms. Further study of the underlying mechanisms is warranted.

背景:多发性硬化症(MS)患者白天过度嗜睡(EDS)可能是残疾的重要来源。尽管如此,在这种情况下,其作为患者报告的结果的患病率尚未得到很好的确定,其原因也未得到很好的理解。方法:我们前瞻性地评估EDS作为一项观察性研究的一部分,用于转诊进行诊断性神经眼科检查的患者。通过Epworth嗜睡量表(ESS)评估EDS,并收集视觉数据作为研究方案的一部分。在排除已知的原发性睡眠障碍患者后,对患者数据进行分析。结果:共有69例MS患者纳入分析。平均ESS为6.5,SD为4.3。即使存在最小的平均神经功能障碍,23%的队列也存在ESS≥10(患者确定疾病步骤(PDDS) = 1.5)。ESS评分与年龄、性别、疾病相关残疾、视网膜神经纤维层(RNFL)或视神经炎(ON)无关,但与视觉功能障碍有关。结论:多发性硬化症患者的EDS患病率增加,但其他睡眠障碍无法解释其升高的值,可能存在不同的机制。对潜在机制的进一步研究是必要的。
{"title":"Disease associations of excessive daytime sleepiness in multiple sclerosis: A prospective study.","authors":"Peter V Sguigna,&nbsp;Sabeen Toranian,&nbsp;Lauren M Tardo,&nbsp;Kyle M Blackburn,&nbsp;Lindsay A Horton,&nbsp;Darrel Conger,&nbsp;Ethan Meltzer,&nbsp;R Nick Hogan,&nbsp;Morgan C McCreary,&nbsp;Phyllis C Zee,&nbsp;Joseph S Takahashi,&nbsp;Benjamin M Greenberg","doi":"10.1177/20552173231159560","DOIUrl":"https://doi.org/10.1177/20552173231159560","url":null,"abstract":"<p><strong>Background: </strong>Excessive daytime sleepiness (EDS) in multiple sclerosis (MS) can be a significant source of disability. Despite this, its prevalence as a patient-reported outcome in this condition has not been well established, and its causes are not well understood.</p><p><strong>Methods: </strong>We prospectively assessed EDS as part of an observational study for patients referred for diagnostic neuro-ophthalmological testing. EDS was evaluated by the Epworth Sleepiness Scale (ESS), and visual data were also collected as part of a research protocol. Analysis with patient data was performed following the exclusion of patients with known primary sleep disorders.</p><p><strong>Results: </strong>A total of 69 patients with MS were included in the analysis. The mean ESS was 6.5 with a SD of 4.3. ESS ≥ 10 was present in 23% of the cohort even in the presence of minimal mean neurological disability (Patient Determined Disease Steps (PDDS) = 1.5). The ESS score was not associated with age, sex, disease-related disability, retinal nerve fiber layer (RNFL), or optic neuritis (ON), but displayed an association with visual dysfunction.</p><p><strong>Conclusions: </strong>There is an increased prevalence of EDS in MS. The increased values of the ESS are not explained by other sleep disorders, suggesting separate mechanisms. Further study of the underlying mechanisms is warranted.</p>","PeriodicalId":18961,"journal":{"name":"Multiple Sclerosis Journal - Experimental, Translational and Clinical","volume":"9 1","pages":"20552173231159560"},"PeriodicalIF":2.8,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/79/59/10.1177_20552173231159560.PMC10017949.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9152425","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
期刊
Multiple Sclerosis Journal - Experimental, Translational and Clinical
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