BACKGROUND A significant proportion of patients with multiple sclerosis (MS) show cognitive impairment. OBJECTIVE To evaluate the effect of 2-year treatment with oral dimethyl fumarate (DMF) on cognition in relapsing remitting MS (RRMS). METHODS In this prospective single-arm study RRMS patients treated with DMF underwent a wide battery of tests, including an extensive neuropsychological evaluation, clinical and patient-reported outcomes (PROs) and quality of life (QoL). Primary endpoints were the proportion of patients with cognitive impairment at baseline and of patients with cognitive worsening over 2 years. RESULTS Overall, 217 patients (74.2% females, mean age 37.3 years) receiving DMF were recruited, and 156 (67.2%) completed the study. Of the 49 patients with cognitive impairment at baseline, 34 had 2-year data: 15 (44.1%) patients worsened and 19 (55.9%) did not. The cognitive impairment index improved in one third of patients at 2 years. Less than 20% of patients had relapses at 2 years (annualized relapse rate: 0.190). Few patients had disability progression. PROs (fatigue, depression, impairment in work/social activities), QoL, and most of neuropsychological tests significantly improved vs. baseline. CONCLUSION The 2-year treatment with DMF was associated with slowing of cognitive impairment and with significant improvements in QoL and psychosocial function.

中文翻译：

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富马酸二甲酯治疗2年对复发性多发性硬化症患者认知和功能障碍的影响。

背景技术患有多发性硬化症（MS）的患者中很大一部分显示出认知障碍。目的评价口服富马酸二甲酯（DMF）治疗两年对复发缓解型MS（RRMS）认知的影响。方法在这项前瞻性单臂研究中，接受DMF治疗的RRMS患者接受了一系列测试，包括广泛的神经心理学评估，临床和患者报告的结局（PRO）和生活质量（QoL）。主要终点是基线时认知功能障碍患者和两年内认知功能恶化患者的比例。结果总共招募了217位接受DMF的患者（女性74.2％，平均年龄37.3岁），其中156位患者（67.2％）完成了研究。在基线时有认知障碍的49位患者中，有34位具有2年数据：15位（44。1％的患者恶化，而19例（55.9％）没有恶化。2岁时三分之一的患者的认知障碍指数有所改善。不到20％的患者在2年时复发（年复发率：0.190）。很少有患者有残疾进展。与基线相比，PRO（疲劳，抑郁，工作/社交活动受损），QoL和大多数神经心理学测试均得到明显改善。结论DMF治疗2年与认知障碍减慢，生活质量和社会心理功能显着改善有关。和大多数神经心理学测试相比，基线水平有明显改善。结论DMF治疗2年与认知障碍减慢，生活质量和社会心理功能显着改善有关。和大多数神经心理学测试相比，基线水平有明显改善。结论DMF治疗2年与认知障碍减慢，生活质量和社会心理功能显着改善有关。