Comparative efficacy of first-line natalizumab vs IFN-beta or glatiramer acetate in relapsing MS

Abstract

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]