TY - JOUR
T1 - Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS
AU - Spelman, Tim
AU - Kalincik, Tomas
AU - Jokubaitis, Vilija G
AU - Zhang, Annie
AU - Pellegrini, Fabio
AU - Wiendl, Heinz S
AU - Belachew, Shibeshih
AU - Hyde, Robert
AU - Verheul, Freek
AU - Lugaresi, Alessandra
AU - Havrdová, Eva
AU - Horáková, Dana
AU - Grammond, Pierre
AU - Duquette, Pierre Pascal
AU - Prat, Alexandre
AU - Iuliano, Gerardo
AU - Terzi, Murat
AU - Izquierdo, Guillermo
AU - Hupperts, Raymond M.M.
AU - Boz, Cavit
AU - Pucci, Eugenio
AU - Giuliani, Giorgio
AU - Sola, Patrizia
AU - Spitaleri, Daniele L.A.
AU - Lechner-Scott, Jeannette
AU - Bergamaschi, Roberto
AU - Grand'Maison, François
AU - Granella, Franco
AU - Kappos, Ludwig D
AU - Trojano, Maria
AU - Butzkueven, Helmut
AU - on behalf of the MSBase Investigators and the TOP investigators
PY - 2016/4/1
Y1 - 2016/4/1
N2 - Background: 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. Methods: 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, 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-β/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-β/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-β/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-β/GA.
AB - Background: 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. Methods: 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, 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-β/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-β/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-β/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-β/GA.
UR - http://www.scopus.com/inward/record.url?scp=84962686361&partnerID=8YFLogxK
U2 - 10.1212/CPJ.0000000000000227
DO - 10.1212/CPJ.0000000000000227
M3 - Article
AN - SCOPUS:84962686361
SN - 2163-0402
VL - 6
SP - 102
EP - 115
JO - Neurology: Clinical Practice
JF - Neurology: Clinical Practice
IS - 2
ER -