TY - JOUR
T1 - Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis
AU - Radue, Ernst-Wilhelm
AU - Stuart, William H
AU - Calabresi, Peter A
AU - Confavreux, Christian
AU - Galetta, Steven L
AU - Rudick, Richard A
AU - Lublin, Fred D
AU - Weinstock-Guttman, Bianca
AU - Wynn, Daniel R
AU - Fisher, Elizabeth
AU - Papadopoulou, Athina
AU - Lynn, Frances
AU - Panzara, Michael A
AU - Sandrock, Alfred W
AU - SENTINEL Investigators
AU - Sørensen, Per Soelberg
AU - Blinkenberg, Morten Bjørn
N1 - Copyright 2010 Elsevier B.V. All rights reserved.
PY - 2010/5/15
Y1 - 2010/5/15
N2 - The SENTINEL study showed that the addition of natalizumab improved outcomes for patients with relapsing multiple sclerosis (MS) who had experienced disease activity while receiving interferon beta-1a (IFNβ-1a) alone. Previously unreported secondary and tertiary magnetic resonance imaging (MRI) measures are presented here. Patients received natalizumab 300 mg (n = 589) or placebo (n = 582) intravenously every 4 weeks plus IFNβ-1a 30 μg intramuscularly once weekly. Annual MRI scans allowed comparison of a range of MRI end points versus baseline. Over 2 years, 67% of patients receiving natalizumab plus IFNβ-1a remained free of new or enlarging T2-lesions compared with 30% of patients receiving IFNβ-1a alone. The mean change from baseline in T2 lesion volume over 2 years decreased in patients receiving natalizumab plus IFNβ-1a and increased in those receiving IFNβ-1a alone (-277.5 mm3 versus 525.6 mm3; p < 0.001). Compared with IFNβ-1a alone, add-on natalizumab therapy resulted in a smaller increase in mean T1-hypointense lesion volume after 2 years (1821.3 mm3 versus 2210.5 mm3; p < 0.001), a smaller mean number of new T1-hypointense lesions over 2 years (2.3 versus 4.1; p < 0.001), and a slower rate of brain atrophy during the second year of therapy (-0.31% versus -0.40%; p = 0.020). Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and T2 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFNβ-1a alone.
AB - The SENTINEL study showed that the addition of natalizumab improved outcomes for patients with relapsing multiple sclerosis (MS) who had experienced disease activity while receiving interferon beta-1a (IFNβ-1a) alone. Previously unreported secondary and tertiary magnetic resonance imaging (MRI) measures are presented here. Patients received natalizumab 300 mg (n = 589) or placebo (n = 582) intravenously every 4 weeks plus IFNβ-1a 30 μg intramuscularly once weekly. Annual MRI scans allowed comparison of a range of MRI end points versus baseline. Over 2 years, 67% of patients receiving natalizumab plus IFNβ-1a remained free of new or enlarging T2-lesions compared with 30% of patients receiving IFNβ-1a alone. The mean change from baseline in T2 lesion volume over 2 years decreased in patients receiving natalizumab plus IFNβ-1a and increased in those receiving IFNβ-1a alone (-277.5 mm3 versus 525.6 mm3; p < 0.001). Compared with IFNβ-1a alone, add-on natalizumab therapy resulted in a smaller increase in mean T1-hypointense lesion volume after 2 years (1821.3 mm3 versus 2210.5 mm3; p < 0.001), a smaller mean number of new T1-hypointense lesions over 2 years (2.3 versus 4.1; p < 0.001), and a slower rate of brain atrophy during the second year of therapy (-0.31% versus -0.40%; p = 0.020). Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and T2 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFNβ-1a alone.
U2 - 10.1016/j.jns.2010.02.012
DO - 10.1016/j.jns.2010.02.012
M3 - Journal article
SN - 0022-510X
VL - 292
SP - 28
EP - 35
JO - Journal of the Neurological Sciences
JF - Journal of the Neurological Sciences
IS - 1-2
ER -