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

Health and Quality of Life Outcomes

Research

Sonalee S Agarwal¹  Krithika Rajagopalan¹  David M Kern²  Siddhesh A Kamat²  Judith J Stephenson²  Ruth Zeidman³  John Foley⁴ 

[1] Biogen Idec Inc., 14 Cambridge Center, 02142, Cambridge, MA, USA;HealthCore Inc., 800 Delaware Avenue, Fifth Floor, 19801, Wilmington, DE, USA;Medaxial Group, 61 Webber Street, SE1 0RF, London, UK;Rocky Mountain Multiple Sclerosis Clinic, Rocky Mountain Neurological Associates, 370 E 9th Ave, STE 106, 84103, Salt Lake City, UT, USA;

关键词: Cognitive function;    Health-related quality of life;    Multiple sclerosis;    Natalizumab;    Patient-reported outcomes;   

DOI  :  10.1186/1477-7525-10-155

 received in 2012-07-11, accepted in 2012-12-13,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundNatalizumab (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.MethodsPRO 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.ResultsA 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).ConclusionsPRO 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.

【 授权许可】

CC BY   
© Stephenson et al.; licensee BioMed Central Ltd. 2012