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Health‐related quality of life in multiple sclerosis: effects of natalizumab
Author(s) -
Rudick Richard A.,
Miller Deborah,
Hass Steve,
Hutchinson Michael,
Calabresi Peter A.,
Confavreux Christian,
Galetta Steven L.,
Giovani Gavin,
Havrdova Eva,
Kappos Ludwig,
Lublin Fred D.,
Miller David H.,
O'Connor Paul W.,
Phillips J. Theodore,
Polman Chris H.,
Radue ErnstWilhelm,
Stuart William H.,
Wajgt Andrzej,
WeinstockGuttman Bianca,
Wynn Daniel R.,
Lynn Frances,
Panzara Michael A.
Publication year - 2007
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.21163
Subject(s) - natalizumab , multiple sclerosis , medicine , expanded disability status scale , visual analogue scale , quality of life (healthcare) , placebo , interferon beta 1a , population , physical therapy , interferon beta , psychiatry , pathology , alternative medicine , nursing , environmental health
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 300mg (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‐β‐1a) plus natalizumab 300mg (n = 589), or IFN‐β‐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. Interpretation 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. Ann Neurol 2007