%0 Journal Article
%A Spelman, Tim
%A Kalincik, Tomas
%A Jokubaitis, Vilija
%A Zhang, Annie
%A Pellegrini, Fabio
%A Wiendl, Heinz
%A Belachew, Shibeshih
%A Hyde, Robert
%A Verheul, Freek
%A Lugaresi, Alessandra
%A Havrdova, Eva
%A Horakova, Dana
%A Grammond, Pierre
%A Duquette, Pierre
%A Prat, Alexandre
%A Iuliano, Gerardo
%A Terzi, Murat
%A Izquierdo, Guillermo
%A Hupperts, Raymond M. M.
%A Boz, Cavit
%A Pucci, Eugenio
%A Giuliani, Giorgio
%A Sola, Patrizia
%A Spitaleri, Daniele L. A.
%A Lechner-Scott, Jeannette
%A Bergamaschi, Roberto
%A Grand'Maison, Francois
%A Granella, Franco
%A Kappos, Ludwig
%A Trojano, Maria
%A Butzkueven, Helmut
%A MSBase Investigators TOP Investiga
%T Comparative efficacy of first-line natalizumab vs IFN-beta or glatiramer acetate in relapsing MS
%D 2016
%@ 2163-0402
%U http://hdl.handle.net/10668/19139
%X Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-beta (IFN-beta)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-beta/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-beta/GA to 0.20 (0.63) (p [signed-rank] = 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-beta/GA to 0.20 (0.63) (p [signed-rank] = 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-beta/GA to 0.20 (0.63) (p [signed-rank] = 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-beta/GA to 0.20 (0.63) (p [signed-rank]
%K Remitting multiple-sclerosis
%K Long-term safety
%K Patient selection
%K Disease-activity
%K Interferon-beta
%K Double-blind
%K Predictors
%K Benefits
%K Outcomes
%K Risk
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