JOURNAL OF THE NEUROLOGICAL SCIENCES, cilt.292, ss.28-35, 2010 (SCI-Expanded, Scopus)
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 (IFN beta-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 IFN beta-1a 30 mu g 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 IFN beta-1a remained free of new or enlarging T2-lesions compared with 30% of patients receiving IFN beta-1a alone. The mean change from baseline in 12 lesion volume over 2 years decreased in patients receiving natalizumab plus IFN beta-1a and increased in those receiving IFN beta-1a alone (-277.5 mm(3) versus 525.6 mm(3); p<0.001). Compared with IFN beta-1a alone, add-on natalizumab therapy resulted in a smaller increase in mean T1-hypointense lesion volume after 2 years (18213 mm(3) versus 2210.5 mm(3); 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 (-031% versus -0.40%; p = 0.020). Natalizumab add-on therapy reduced gadolinium-enhancing, T1-hypointense, and 12 MRI lesion activity and slowed brain atrophy progression in patients with relapsing MS who experienced disease activity despite treatment with IFN beta-1a alone. (C) 2010 Elsevier B.V. All rights reserved.