Ontology highlight
ABSTRACT: Background
We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-? (IFN-?)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries.Methods
The study population initiated IFN-?/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ?3 months of on-treatment follow-up, and had active RRMS, defined as ?1 gadolinium-enhancing lesion on cerebral MRI at baseline or ?1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity.Results
First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-?/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-?/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups.Conclusions
This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-?/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients.Classification of evidence
This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-?/GA.
SUBMITTER: Spelman T
PROVIDER: S-EPMC4828679 | biostudies-literature | 2016 Apr
REPOSITORIES: biostudies-literature
Spelman Tim T Kalincik Tomas T Jokubaitis Vilija V Zhang Annie A Pellegrini Fabio F Wiendl Heinz H Belachew Shibeshih S Hyde Robert R Verheul Freek F Lugaresi Alessandra A Havrdová Eva E Horáková Dana D Grammond Pierre P Duquette Pierre P Prat Alexandre A Iuliano Gerardo G Terzi Murat M Izquierdo Guillermo G Hupperts Raymond M M RM Boz Cavit C Pucci Eugenio E Giuliani Giorgio G Sola Patrizia P Spitaleri Daniele L A DL Lechner-Scott Jeannette J Bergamaschi Roberto R Grand'Maison François F Granella Franco F Kappos Ludwig L Trojano Maria M Butzkueven Helmut H
Neurology. Clinical practice 20160401 2
<h4>Background</h4>We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries.<h4>Methods</h4>The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, a ...[more]