Sustained efficacy of natalizumab in the treatment of relapsing-remitting multiple sclerosis independent of disease activity and disability at baseline: real-life data from a Swiss cohort.
OBJECTIVE
Therapy for relapsing-remitting multiple sclerosis with natalizumab (Tysabri; Biogen Idec) has been shown to be effective in the reduction of the clinical relapse rate and disability progression. However, real-life longitudinal data, including years before baseline, are rare.


METHODS
An observational single-center study was carried out. We analyzed data from 64 consecutive patients with multiple sclerosis.


RESULTS
After 1 year of treatment (n = 64), score on the Expanded Disability Status Scale (EDSS) decreased by 0.47 points (P = 0.047) and the annualized relapse rate (ARR) decreased by 82% (P < 0.001). After 2 years (n = 41), EDSS score was still reduced by 0.28 (not significant) and ARR was reduced by 69% (P < 0.001). After 3 years (n = 23), EDSS score was reduced by 0.26 (not significant), and ARR was reduced by 77% (P < 0.001). Reduction of EDSS score and ARR did not depend on baseline ARR (1-2 vs >2) or EDSS score and was not biased by exceptional high disease activity or relapses around baseline.


CONCLUSIONS
These real-life data reinforce that natalizumab is effective over years, reduces ARR, and stabilizes EDSS score independent of baseline ARR, baseline EDSS score, or baseline treatment.
Department of Neurology, University Hospital Zurich, Zurich, Switzerland.
Ulf
U
Kallweit
Ilijas
I
Jelcic
Nathalie
N
Braun
Heike
H
Fischer
Björn
B
Zörner
Bettina
B
Schreiner
Arseny A
AA
Sokolov
Roland
R
Martin
Michael
M
Weller
Michael
M
Linnebank
D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015331:Cohort Studies; D016208:Databases, Factual / Q000639:trends; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology*; D000069442:Natalizumab; D013557:Switzerland / Q000453:epidemiology; D016896:Treatment Outcome; D055815:Young Adult
D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab