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By Chris Berrie
GLASGOW, UK -- September 11, 2006 -- Monotherapy with the alpha4 integrin antagonist natalizumab results in significant improvements in scores on health-related quality of life (QoL) questionnaires in patients with relapsing-remitting multiple sclerosis (MS), according to results of a substudy from a multicentre, randomised, double-blind, placebo-controlled, phase 3 clinical trial.
The findings were presented here on September 5th at the 10th Congress of the European Federation of Neurological Societies (EFNS) by Michael Hutchinson, MD, professor of neurology, department of neurology, St. Vincent's University Hospital, Dublin, Ireland, on behalf of the AFFIRM study investigators.
Scores on the HRQoL has been shown to be significantly lower for patients with MS than for healthy individuals, there is no Class 1 evidence that disease-modifying therapies can improve HRQoL for patients with relapsing MS, Dr. Hutchinson said.
Previous studies have indicated a significant relationship between the degree of physical disability and HRQoL scores in patients with MS, with scores on the Expanded Disability Status Scale (EDSS) and the MS Functional Composite (MSFC) showing correlations with health-related QoL, as measured by the MSQoL-54 survey.
To determine the effects of natalizumab on health-related QoL and to investigate the relationship between these scores and disability levels in patients with relapsing-remitting MS, Dr. Hutchinson and colleagues conducted an analysis of data from the AFFIRM study.
The researchers evaluated 627 patients who were treated with natalizumab and 315 patients with placebo, at a dose of 300 mg IV every 4 weeks for up to 116 weeks.
Patients were 18 to 50 years of age and had a diagnosis of relapsing-remitting MS and an Expanded Disability Status Score (EDSS) of 0.0 to 5.0 inclusive. They also had at least 1 documented clinical relapses within the prior 12 months and lesions on magnetic resonance imaging (MRI) consistent with MS.
Primary end points of the AFFIRM trial were the annualized relapse rate at 1 year and sustained disability progression at 2 years.
Measures of disability and health-related QoL included disability progression defined as a 1 or greater point increase in EDSS score from baseline, sustained for 12 weeks, and the score on the health-related QoL short form (SF)-36, which represents the patient's opinion as to the result of treatment and has been shown to be a valid instrument with stability and responsiveness to change in a number of MS populations.
Dr. Hutchinson noted the significant reduction in disability progression provided by natalizumab (placebo, 29%; natalizumab, 17%; hazard ratio, 0.58; 95% confidence interval, 0.43-0.77; P = .0002). Similarly, natalizumab promoted improvements in scores on the MSFC and the SF-36.
For the SF-36, the mean changes from baseline make it clear that patients were a lot more satisfied with natalizumab than with placebo, both according to the physical (0.7 vs -1.3, respectively; P = .003) and the mental (2.0 vs -0.5, respectively; P = .011) aspects of the SF-36, Dr. Hutchinson said.
Finally, with regard to the correlation between the disability status of the EDSS score and the health-related QoL status on the SF-36, the present study demonstrated a significant moderate negative correlation of EDSS with both the SF-36 physical (placebo, -0.545; natalizumab, -0.548; P < .001) and, to a lesser extent, the SF-36 mental (placebo, -0.289; natalizumab, -0.136; P < .001) status, according to the researchers.
Scores on the MSFC also showed a moderate positive correlation with the SF-36 physical scores (placebo, 0.410; natalizumab, 0.404; P < .001), with a lesser correlation with the SF-36 mental (placebo, 0.268; natalizumab, 0.145, < .001) scores.
This consideration of the relationships between health-related QoL as measured by the SF-36 and disability as measured by the EDSS and MSFC demonstrate moderate but significant correlations between these patient-completed and clinician-led assessment scales for patients with RRMS.
This study was sponsored by Biogen IDEC.
* Polman CH, O'Connor PW, Havrdova E, et al; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.
[Presentation title: The Effects of Natalizumab on Disability and Health-Related Quality of Life in Patients With Relapsing MS. Abstract SC326]
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