Multiple sclerosis associated fatigue during natalizumab treatment.
OBJECTIVE
To assess multiple sclerosis (MS) associated fatigue after the first 6 months of natalizumab treatment.


METHODS
Prospective, open-label, uncontrolled study. Fatigue was measured before treatment initiation and at month 6 with the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) in 42 patients. Subjective impression of well-being was assessed with a visual analogue scale (1-10).


RESULTS
42 patients were followed (mean age 35.1 years, 60% female, mean EDSS 3.7). The mean total MFIS were 45.8 (17.5) at baseline and decreased to 40.1 (18.0) (p<0.01) at month 6. Mean scores on the VAS for subjective impression of well-being increased from 5.5 (1.9) to 6.1 (2.1) at month 6 (p<0.01). Pre-treatment annual relapse rate decreased from 2.2 to 0.2, gadolinium enhancing lesions were reduced by 96% with natalizumab. There was no correlation of gadolineum enhancing lesions and fatigue scores.


CONCLUSIONS
Fatigue and well-being improved after treatment initiation with natalizumab. A randomized controlled trial is necessary to come to definite conclusions as to a potential effect of natalizumab on fatigue in MS.
Putzki
Norman
N
Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. norman.putzki@uni-due.de
Yaldizli
Ozgür
O
Tettenborn
Barbara
B
Diener
Hans Christoph
HC
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015331:Cohort Studies; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D005260:Female; D005682:Gadolinium; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D000069442:Natalizumab; D011446:Prospective Studies; D012008:Recurrence; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab; D005682:Gadolinium