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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2012

Open Access 01-12-2012 | Research

Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study

Authors: Judith J Stephenson, David M Kern, Sonalee S Agarwal, Ruth Zeidman, Krithika Rajagopalan, Siddhesh A Kamat, John Foley

Published in: Health and Quality of Life Outcomes | Issue 1/2012

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Abstract

Background

Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) significantly reduces the relapse rate and disability progression, and improves health-related quality of life (HRQoL), in patients with relapsing-remitting multiple sclerosis. We investigated the impact of natalizumab on patient-reported outcomes (PROs) in a real-world setting.

Methods

PRO data were collected from patients enrolled in a longitudinal real-world study using validated measures administered as surveys before the patients initiated natalizumab treatment and after the 3rd, 6th, and 12th monthly infusion. HRQoL, ability to carry out daily activities, disability level, and impact on cognitive functioning and fatigue were assessed.

Results

A total of 333 patients completed 12 months of assessments. After 12 months of natalizumab treatment, 69% to 88% of patients reported a positive outcome (either an improvement or no further decline) in all PRO measures assessed. Significant improvements in general and disease-specific HRQoL were observed after three infusions, both with physical (p < .01) and psychological (p < .001) measures, and were sustained after 12 infusions (all p < .001). The impact of multiple sclerosis on cognitive functioning and fatigue was significantly reduced (both p < .001 after 3 and 12 infusions).

Conclusions

PRO measures were improved with natalizumab in a real-world setting. The improvements were observed as early as after 3 months and sustained over a 12-month period. The improvements in PROs show that, in clinical practice, the clinical benefits of natalizumab are translated into patient-reported benefits.
Appendix
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Metadata
Title
Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study
Authors
Judith J Stephenson
David M Kern
Sonalee S Agarwal
Ruth Zeidman
Krithika Rajagopalan
Siddhesh A Kamat
John Foley
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2012
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-10-155

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