Wilken Jeffrey, Kane Robert L, Sullivan Cynthia L, Gudesblatt Mark, Lucas Sylvia, Fallis Robert, You Xiaojun, Foulds Pam
Department of Neurology, Georgetown University Hospital, and Washington Neuropsychology Research Group, LLC, Washington, DC, USA (JW, CLS); Department of Neurology, University of Maryland School of Medicine, Baltimore, MD, and Washington Neuropsychology Research Group, LLC, Washington, DC, USA (RLK); South Shore Neurologic Associates, Patchogue, NY, USA (MG); Department of Neurology, University of Washington, Seattle, WA, USA (SL); St. Thomas Hospital, Nashville, TN, USA (RF); and Biogen Idec Inc., Weston, MA, USA (XY, PF).
Int J MS Care. 2013 Fall;15(3):120-8. doi: 10.7224/1537-2073.2012-043.
Fatigue and cognitive impairment are debilitating features of multiple sclerosis (MS). ENER-G was a 12-month, open-label, multicenter, single-arm observational study designed to evaluate changes in fatigue and cognition in MS patients treated with natalizumab. Adults with relapsing MS and initiating natalizumab were enrolled. The primary endpoint was change in Visual Analog Scale for Fatigue (VAS-F) score over 12 weeks. Changes in Modified Fatigue Impact Scale (MFIS) score, Fatigue Severity Scale (FSS) score, and cognitive performance, using Automated Neuropsychological Assessment Metrics (ANAM), were also assessed. Patients (N = 89) had a mean age of 41 years and a median Expanded Disability Status Scale score of 3.0, and 83% had used at least two prior MS therapies. Significant improvements were observed and maintained at 12 weeks in VAS-F (mean ± SD baseline score, 77.7 ± 10.2; mean ± SD change, -14.9 ± 17.1; P < .0001), MFIS (mean baseline score, 59.1 ± 12.2; mean change, -7.4 ± 11.8; P < .0001), and FSS (median baseline score, 6.3 [range, 3.9-7.0]; median change, -0.4 [range, -2.9-1.4]; P < .0001). Cognitive performance remained stable or improved (depending on the ANAM measure). Thus significant improvements in fatigue were maintained over time, and cognitive performance improved or remained stable up to 48 weeks after initiation of natalizumab in MS patients with some degree of fatigue.
疲劳和认知障碍是多发性硬化症（MS）的致残特征。ENER-G是一项为期12个月的开放标签、多中心、单臂观察性研究，旨在评估接受那他珠单抗治疗的MS患者的疲劳和认知变化。纳入了复发型MS且开始使用那他珠单抗的成年人。主要终点是12周内疲劳视觉模拟量表（VAS-F）评分的变化。还评估了使用自动化神经心理评估指标（ANAM）的改良疲劳影响量表（MFIS）评分、疲劳严重程度量表（FSS）评分和认知表现。患者（N = 89）的平均年龄为41岁，扩展残疾状态量表评分中位数为3.0，83%的患者至少使用过两种先前的MS治疗方法。在12周时观察到VAS-F（平均±标准差基线评分，77.7±10.2；平均±标准差变化，-14.9±17.1；P <.0001）、MFIS（平均基线评分，59.1±12.2；平均变化，-7.4±11.8；P <.0001）和FSS（中位数基线评分，6.3[范围，3.9 - 7.0]；中位数变化，-0.4[范围，-2.9 - 1.4]；P <.0001）有显著改善并得以维持。认知表现保持稳定或有所改善（取决于ANAM测量指标）。因此，随着时间的推移，疲劳有显著改善，在开始使用那他珠单抗后长达48周，有一定程度疲劳的MS患者的认知表现有所改善或保持稳定。
