Stephen Krieger , Myassar Zarif , Barbara Bumstead , Marijean Buhse , Olivia Kaczmarek , Jared Srinivasan , Nuno Barros , Diana Sima , Annemie Ribbens , Wim Van Hecke , James B. Lewin , Jason P. Mendoza , Mark Gudesblatt
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引用次数: 0
摘要
目的：评估富马酸二甲酯（DMF）对复发缓解型多发性硬化症（RRMS）患者亚临床生物标志物的实际影响，并将结果与之进行比较：评估富马酸二甲酯（DMF）对复发缓解型多发性硬化症（RRMS）患者亚临床生物标志物的实际影响，并与临床试验结果进行比较：方法：回顾性收集102例RRMS患者的磁共振成像（MRI）数据，并使用icobrain进行处理，以评估脑萎缩情况并辅助半人工病灶计数：结果：DMF启动后头3年的平均（±SD）年化脑容量变化百分比为分别为-0.33±0.68%/年、-0.10±0.60%/年和-0.35±0.71%/年。73.7%、77.3%和73.3%的患者在第1年、第2年和第3年未发现新的FLAIR病变：这项真实世界研究的结果与之前的 DMF III 期临床试验结果一致，支持临床试验中观察到的效果在真实世界临床环境中的可推广性。
Evaluating the effect of dimethyl fumarate on subclinical biomarkers in a real-world patient cohort
Objective
Evaluate the real-world effect of dimethyl fumarate (DMF) on subclinical biomarkers in patients with relapsing-remitting multiple sclerosis (RRMS) and compare with results from clinical trials.
Methods
Magnetic resonance imaging (MRI) data from 102 RRMS patients were retrospectively collected and processed using icobrain to assess brain atrophy and to assist semi-manual lesion count.
Results
Mean (±SD) annualized percent brain volume change in the first 3 years after DMF-initiation were: −0.33 ± 0.68, −0.10 ± 0.60, and − 0.35 ± 0.71%/year, respectively. No new FLAIR lesions were detected in 73.7%, 77.3%, and 73.3% of the patients during years 1, 2, and 3.
Conclusions
Results of this real-world study were consistent with previous DMF phase III clinical trials, supporting the generalizability of the effects observed in clinical trials to the real-world clinical setting.
期刊介绍：
The Journal of Neuroimmunology affords a forum for the publication of works applying immunologic methodology to the furtherance of the neurological sciences. Studies on all branches of the neurosciences, particularly fundamental and applied neurobiology, neurology, neuropathology, neurochemistry, neurovirology, neuroendocrinology, neuromuscular research, neuropharmacology and psychology, which involve either immunologic methodology (e.g. immunocytochemistry) or fundamental immunology (e.g. antibody and lymphocyte assays), are considered for publication.
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