Wilken J, Kane RL, Sullivan CL, Gudesblatt M, Lucas S, Fallis R, You X, Foulds P.Changes
in Fatigue and Cognition in Patients with Relapsing Forms of Multiple
Sclerosis Treated with Natalizumab: The ENER-G Study. Int J MS Care. 2013 Fall;15(3):120-8.
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.
This
study provides further evidence that on-going inflammation is part of
the problem with fatigue. Deal with the former and the latter get
relieved to some extent.
Labels: Fatigue