Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
Department of Radiology and Nuclear Medicine, Amsterdam UMC, Amsterdam, The Netherlands.
Eur J Neurol. 2022 Jul;29(7):2024-2035. doi: 10.1111/ene.15314. Epub 2022 Apr 4.
In the REFLEX trial (ClinicalTrials.gov identifier: NCT00404352), patients with a first clinical demyelinating event (FCDE) displayed significantly delayed onset of multiple sclerosis (MS; McDonald criteria) when treated with subcutaneous interferon beta-1a (sc IFN β-1a) versus placebo. This post hoc analysis evaluated the effect of sc IFN β-1a on spatio-temporal evolution of disease activity, assessed by changes in T2 lesion distribution, in specific brain regions of such patients and its relationship with conversion to MS.
Post hoc analysis of baseline and 24-month magnetic resonance imaging data from FCDE patients who received sc IFN β-1a 44 μg once or three times weekly, or placebo in the REFLEX trial. Patients were grouped according to McDonald MS status (converter/non-converter) or treatment (sc IFN β-1a/placebo). For each patient group, a baseline lesion probability map (LPM) and longitudinal new/enlarging and shrinking/disappearing LPMs were created. Lesion location/frequency of lesion occurrence were assessed in the white matter.
At Month 24, lesion frequency was significantly higher in the anterior thalamic radiation (ATR) and corticospinal tract (CST) of converters versus non-converters (p < 0.05). Additionally, the overall distribution of new/enlarging lesions across the brain at Month 24 was similar in placebo- and sc IFN β-1a-treated patients (ratio: 0.95). Patients treated with sc IFN β-1a versus placebo showed significantly lower new lesion frequency in specific brain regions (cluster corrected): ATR (p = 0.025), superior longitudinal fasciculus (p = 0.042), CST (p = 0.048), and inferior longitudinal fasciculus (p = 0.048).
T2 lesion distribution in specific brain locations predict conversion to McDonald MS and show significantly reduced new lesion occurrence after treatment with sc IFN β-1a in an FCDE population.
REFLEX 试验（ClinicalTrials.gov 标识符：NCT00404352）中，与安慰剂相比，接受皮下注射干扰素 β-1a（sc IFN β-1a）治疗的首次临床脱髓鞘事件（FCDE）患者多发性硬化症（MS； McDonald 标准）的发病时间明显延迟。本事后分析评估了 sc IFN β-1a 对这些患者特定脑区疾病活动时空演变的影响，通过 T2 病变分布的变化来评估，并评估其与向 MS 转化的关系。
REFLEX 试验中接受 sc IFN β-1a44μg 每周一次或三次或安慰剂治疗的 FCDE 患者的基线和 24 个月磁共振成像数据的事后分析。根据 McDonald MS 状态（转化者/非转化者）或治疗（sc IFN β-1a/安慰剂）对患者进行分组。为每个患者组创建基线病变概率图（LPM）和纵向新/扩大和缩小/消失 LPM。评估白质中的病变位置/病变发生频率。
在第 24 个月时，转化者的前丘脑辐射（ATR）和皮质脊髓束（CST）中的病变频率明显高于非转化者（p<0.05）。此外，在第 24 个月时，安慰剂和 sc IFN β-1a 治疗患者大脑中总体新/扩大病变的分布相似（比值：0.95）。与安慰剂相比，接受 sc IFN β-1a 治疗的患者在特定脑区的新病变频率显著降低（簇校正）：ATR（p=0.025）、上纵束（p=0.042）、CST（p=0.048）和下纵束（p=0.048）。
特定脑区 T2 病变分布可预测向 McDonald MS 的转化，并在 FCDE 人群中接受 sc IFN β-1a 治疗后，新病变的发生明显减少。
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