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The online version of this article (doi:10.1186/1477-7525-10-155) contains supplementary material, which is available to authorized users.
Judith J. Stephenson is an employee of HealthCore, a research and consulting company. All of her research activities are industry-sponsored. However, she receives no direct compensation as a result of grants or contracts, other than her salary from HealthCore. David M. Kern receives no direct compensation as a result of grants or contracts other than his salary from HealthCore. Sonalee S. Agarwal is an employee of Biogen Idec. Ruth Zeidman is an employee of Medaxial Group, but did not receive any direct compensation for her involvement other than her regular salary. Krithika Rajagopalan was an employee of Biogen Idec at the time of the study. Siddhesh A. Kamat is an employee of HealthCore and receives no direct compensation as a result of grants or contracts other than his salary from HealthCore. John Foley currently sits on several scientific advisory boards supported by Biogen Idec (since 2008), Avanir (since May 2011), and Genzyme/Sanofi (since April 2011). He has been a participant in speakers bureaus for both Biogen Idec and Teva (since 1995), he is a participant in the speakers bureau for Questcor (since July 2011), and he is a consultant for Genzyme, Avanir, Questcor, and Elan. Dr. Foley does not receive stock, stock options, or royalties from any of these entities.
JJS participated in the design of the study, development of the survey and data collection procedures, statistical analyses, interpretation of the data and drafting of the manuscript. DMK helped draft the statistical analysis plan, performed the analysis, and helped draft the manuscript. SSA participated in data collection, analysis, interpretation and drafting of the manuscript. RZ participated in the interpretation of the data and drafting of the manuscript. KR participated in study design, data collection, and manuscript review. SAK participated in development of the survey and the analysis plan, interpretation of the data, and manuscript review. JF assisted with data interpretation and manuscript review. All authors read and approved the final manuscript.
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.
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.
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).
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.