用稳定的磁共振成像识别多发性硬化症复发的急性临床事件

IF 20.4 1区 医学 Q1 CLINICAL NEUROLOGY
Antoine Gavoille, Fabien Rollot, Romain Casey, Anne Kerbrat, Emmanuelle Le Page, Kevin Bigaut, Guillaume Mathey, Laure Michel, Jonathan Ciron, Aurelie Ruet, Elisabeth Maillart, Pierre Labauge, Hélène Zephir, Caroline Papeix, Gilles Defer, Christine Lebrun-Frenay, Thibault Moreau, Eric Berger, Bruno Stankoff, Pierre Clavelou, Eric Thouvenot, Olivier Heinzlef, Jean Pelletier, Abdullatif Al-Khedr, Olivier Casez, Bertrand Bourre, Philippe Cabre, Abir Wahab, Laurent Magy, Jean-Philippe Camdessanché, Inès Doghri, Solène Moulin, Haifa Ben-Nasr, Céline Labeyrie, Karolina Hankiewicz, Jean-Philippe Neau, Corinne Pottier, Chantal Nifle, Eric Manchon, Bertrand Lapergue, Sandrine Wiertlewski, Jérôme De Sèze, Sandra Vukusic, David Axel Laplaud
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引用次数: 0

摘要

重要性:了解多发性硬化症(MS)临床定义的复发与放射学活动之间的关联对于患者治疗和疗法开发至关重要:调查脑和脊髓磁共振成像(MRI)上被确定为复发但与新的T2病变或钆增强T1病变无关的临床事件:这项多中心观察性队列研究在 2015 年 1 月至 2023 年 6 月期间进行。数据于2023年6月8日从法国多发性硬化症登记处提取。如果复发缓解型多发性硬化症患者在事件发生前12个月和24个月内分别进行了脑部和脊髓磁共振成像,并在事件发生后50天内注射了钆,则所有报告为复发的临床事件均被纳入研究范围:如果脑或脊髓 MRI 上出现新的 T2 病变或钆增强的 T1 病变,则将事件归类为活动性 MRI 复发(RAM),否则归类为稳定性 MRI 急性临床事件(ACES):研究与ACES相关的因素;比较ACES和RAM患者的扩展残疾状态量表(EDSS)病程、复发率、确诊残疾累积(CDA)、复发相关恶化(RAW)、独立于复发活动的进展(PIRA)和向继发性进展(SP)多发性硬化症的转变,并估计每种疾病改变疗法(DMT)下的ACES和RAM发生率:在 31 885 例临床事件中,608 例患者中的 637 例(女性 493 例 [77.4%];平均 [SD] 年龄 35.8 [10.7] 岁)被纳入其中。ACES占166例(26.1%),在接受高效DMTs治疗、病程较长(几率比[OR],1.04;95% CI,1.01-1.07)或出现疲劳(OR,2.14;95% CI,1.15-3.96)的患者中更易发生。ACES 与 EDSS 评分的显著增加有关,但低于 RAM 的相关评分。在指数事件发生之前,ACES 患者的复发率(相对率 [RR],1.21;95% CI,1.01-1.46)、CDA(危险比 [HR],1.54;95% CI,1.13-2.11)和 RAW(HR,1.72;95% CI,1.20-2.45)明显更高。ACES 患者转为 SP 的风险明显更高(HR,2.58;95% CI,1.02-6.51)。虽然RAM率随着DMT的预期疗效而降低,但ACES率在不同DMT中保持稳定:本研究结果引入了多发性硬化症 ACES 的概念,ACES 占复发临床事件的四分之一。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Acute Clinical Events Identified as Relapses With Stable Magnetic Resonance Imaging in Multiple Sclerosis.

Importance: Understanding the association between clinically defined relapses and radiological activity in multiple sclerosis (MS) is essential for patient treatment and therapeutic development.

Objective: To investigate clinical events identified as relapses but not associated with new T2 lesions or gadolinium-enhanced T1 lesions on brain and spinal cord magnetic resonance imaging (MRI).

Design, setting, and participants: This multicenter observational cohort study was conducted between January 2015 and June 2023. Data were extracted on June 8, 2023, from the French MS registry. All clinical events reported as relapses in patients with relapsing-remitting MS were included if brain and spinal cord MRI was performed within 12 and 24 months before the event, respectively, and 50 days thereafter with gadolinium injection.

Exposures: Events were classified as relapses with active MRI (RAM) if a new T2 lesion or gadolinium-enhanced T1 lesion appeared on brain or spinal cord MRI or as acute clinical events with stable MRI (ACES) otherwise.

Main outcomes and measures: Factors associated with ACES were investigated; patients with ACES and RAM were compared regarding Expanded Disability Status Scale (EDSS) course, relapse rate, confirmed disability accrual (CDA), relapse-associated worsening (RAW), progression independent of relapse activity (PIRA), and transition to secondary progressive (SP) MS, and ACES and RAM rates under each disease-modifying therapy (DMT) were estimated.

Results: Among 31 885 clinical events, 637 in 608 patients (493 [77.4%] female; mean [SD] age, 35.8 [10.7] years) were included. ACES accounted for 166 (26.1%) events and were more likely in patients receiving highly effective DMTs, those with longer disease duration (odds ratio [OR], 1.04; 95% CI, 1.01-1.07), or those presenting with fatigue (OR, 2.14; 95% CI, 1.15-3.96). ACES were associated with significant EDSS score increases, lower than those found for RAM. Before the index event, patients with ACES experienced significantly higher rates of relapse (relative rate [RR], 1.21; 95% CI, 1.01-1.46), CDA (hazard ratio [HR], 1.54; 95% CI, 1.13-2.11), and RAW (HR, 1.72; 95% CI, 1.20-2.45). Patients with ACES were at significantly greater risk of SP transition (HR, 2.58; 95% CI, 1.02-6.51). Although RAM rate decreased with DMTs according to their expected efficacy, ACES rate was stable across DMTs.

Conclusions and relevance: The findings in this study introduce the concept of ACES in MS, which accounted for one-fourth of clinical events identified as relapses.

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来源期刊
JAMA neurology
JAMA neurology CLINICAL NEUROLOGY-
CiteScore
41.90
自引率
1.70%
发文量
250
期刊介绍: JAMA Neurology is an international peer-reviewed journal for physicians caring for people with neurologic disorders and those interested in the structure and function of the normal and diseased nervous system. The Archives of Neurology & Psychiatry began publication in 1919 and, in 1959, became 2 separate journals: Archives of Neurology and Archives of General Psychiatry. In 2013, their names changed to JAMA Neurology and JAMA Psychiatry, respectively. JAMA Neurology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.
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