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

Abstract

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.

A prospective, open, non-randomized study on the safety and efficacy of natalizumab (tisabri) in the Russian population of patients with relapsing-remitting multiple sclerosis

“…Как и в ранее проведенных исследованиях [12,26,[37][38][39][40], в данном исследовании натализумаб также обладал благоприятными эффектами в отно-шении качества жизни. Терапия натализумабом привела к улучшениям по обоим опросникам, ис-пользованным в данном исследовании для оценки качества жизни (SF-36 и MSIS-29).…”

Naps-MS

“…[15][16][17]29,30 Improvement occurred rapidly and was significant by the third month. Improvement in sleepiness, as measured by the ESS, was also observed.…”

“…In another study investigating patient-reported outcomes, fatigue and cognition improved during natalizumab therapy. 17 The mechanism whereby natalizumab positively affects fatigue is unknown. One possibility would be an effect on sleep quality.…”

Disease modifying treatments and symptomatic drugs for cognitive impairment in multiple sclerosis: where do we stand?

“…Stephenson et al [19] have conducted a prospective, uncontrolled study in 333 patients on the effect of natalizumab in patient-reported outcomes measures. After 12 months of pharmacological treatment, 69% to 88% of patients reported an improvement in quality of life assessed by the SF-12v2 [20], the MSIS-29 [21], the FS [22], the DS scale [23], fatigue assessed by the MFIS [24] and cognition assessed by the MOS-Cog [25].…”