Novartis Pharma AG, Basel, Switzerland.
Brain Imaging Centre, Montreal Neurological Institute and Hospital, McGill University, Montréal, QC, Canada.
Mult Scler. 2021 Nov;27(13):2062-2076. doi: 10.1177/1352458520988637. Epub 2021 Jan 28.
The Oxford Big Data Institute, multiple sclerosis (MS) physicians and Novartis aim to address unresolved questions in MS with a novel comprehensive clinical trial data set.
The objective of this study is to describe the Novartis-Oxford MS (NO.MS) data set and to explore the relationships between age, disease activity and disease worsening across MS phenotypes.
We report key characteristics of NO.MS. We modelled MS lesion formation, relapse frequency, brain volume change and disability worsening cross-sectionally, as a function of patients' baseline age, using phase III study data (≈8000 patients).
NO.MS contains data of ≈35,000 patients (>200,000 brain images from ≈10,000 patients), with >10 years follow-up. (1) Focal disease activity is highest in paediatric patients and decreases with age, (2) brain volume loss is similar across age and phenotypes and (3) the youngest patients have the lowest likelihood (<25%) of disability worsening over 2 years while risk is higher (25%-75%) in older, disabled or progressive MS patients. Young patients benefit most from treatment.
NO.MS will illuminate questions related to MS characterisation, progression and prognosis. Age modulates relapse frequency and, thus, the phenotypic presentation of MS. Disease worsening across all phenotypes is mediated by age and appears to some extent be independent from new focal inflammatory activity.
牛津大数据研究所、多发性硬化症(MS)医生和诺华公司旨在利用一种新的综合临床试验数据集来解决 MS 中的未解决问题。
本研究旨在描述诺华-牛津多发性硬化症(NO.MS)数据集,并探讨 MS 表型之间的年龄、疾病活动度和疾病恶化之间的关系。
我们报告了 NO.MS 的关键特征。我们使用 III 期研究数据(约 8000 名患者),对 MS 病变形成、复发频率、脑体积变化和残疾恶化进行了横截面建模,作为患者基线年龄的函数。
NO.MS 包含了约 35000 名患者(来自约 10000 名患者的超过 200000 个脑图像)的数据,随访时间超过 10 年。(1)局灶性疾病活动度在儿科患者中最高,并随年龄下降,(2)脑体积丢失在年龄和表型之间相似,(3)年龄最小的患者在 2 年内残疾恶化的可能性最低(<25%),而在年龄较大、残疾或进展性 MS 患者中风险较高(25%-75%)。年轻患者从治疗中获益最大。
NO.MS 将阐明与 MS 特征、进展和预后相关的问题。年龄调节复发频率,从而调节 MS 的表型表现。所有表型的疾病恶化都受年龄的影响,在某种程度上似乎与新的局灶性炎症活动无关。