Health‐related quality of life in multiple sclerosis: effects of natalizumab
- 29 October 2007
- journal article
- research article
- Published by Wiley in Annals of Neurology
- Vol. 62 (4), 335-346
- https://doi.org/10.1002/ana.21163
Abstract
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 2007Keywords
This publication has 35 references indexed in Scilit:
- Quality of life and impairment in patients with multiple sclerosisJournal of Neurology, Neurosurgery & Psychiatry, 2005
- Quality of life during the first 6 months of interferon-b treatment in patients with MSMultiple Sclerosis Journal, 2000
- Cost and health related quality of life consequences of multiple sclerosisMultiple Sclerosis Journal, 2000
- Type I interferons and the quality of life of multiple sclerosis patients. Results from a clinical trial on interferon alfa-2aMultiple Sclerosis Journal, 1999
- The SF-36 Health Survey as a Generic Outcome Measure in Clinical Trials of Patients With Osteoarthritis and Rheumatoid ArthritisMedical Care, 1999
- A comparison of health-related quality of life in patients with epilepsy, diabetes and multiple sclerosisEpilepsy Research, 1996
- Copolymer 1 reduces relapse rate and improves disability in relapsing‐remitting multiple sclerosisNeurology, 1995
- The MOS 36-Item Short-Form Health Survey (SF-36)Medical Care, 1993
- The MOS 36-ltem Short-Form Health Survey (SF-36)Medical Care, 1992
- Rating neurologic impairment in multiple sclerosisNeurology, 1983