Health-related quality of life in multiple sclerosis: effects of natalizumab.
OBJECTIVE
To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab.


METHODS
HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300 mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-beta-1a) plus natalizumab 300 mg (n = 589), or IFN-beta-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated.


RESULTS
Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab.


CONCLUSIONS
HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab.
Rudick
Richard A
RA
Department of Neurology, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Miller
Deborah
D
Hass
Steve
S
Hutchinson
Michael
M
Calabresi
Peter A
PA
Confavreux
Christian
C
Galetta
Steven L
SL
Giovannoni
Gavin
G
Havrdova
Eva
E
Kappos
Ludwig
L
Lublin
Fred D
FD
Miller
David H
DH
O'Connor
Paul W
PW
Phillips
J Theodore
JT
Polman
Chris H
CH
Radue
Ernst-Wilhelm
EW
Stuart
William H
WH
Wajgt
Andrzej
A
Weinstock-Guttman
Bianca
B
Wynn
Daniel R
DR
Lynn
Frances
F
Panzara
Michael A
MA
D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D000069442:Natalizumab; D010146:Pain / Q000453:epidemiology* / Q000517:prevention & control*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D015995:Prevalence; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab