MRI outcomes in a placebo-controlled trial of natalizumab in relapsing MS

D. H. Miller, D. Soon, K. T. Fernando, D. G. MacManus, G. J. Barker, T. A. Yousry, E. Fisher, P. W. O'Connor, J. T. Phillips, C. H. Polman, L. Kappos, M. Hutchinson, E. Havrdova, F. D. Lublin, G. Giovannoni, A. Wajgt, R. Rudick, F. Lynn, M. A. Panzara, A. W. Sandrock

Research output: Contribution to journalArticlepeer-review

278 Scopus citations


BACKGROUND: In a 2-year, placebo-controlled trial (the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] study), involving 942 patients with relapsing multiple sclerosis (MS), natalizumab significantly reduced the relapse rate by 68% and progression of sustained disability by 42% vs placebo. We report the effect of natalizumab on MRI measures from the AFFIRM study. METHODS: The number and volume of gadolinium (Gd)-enhancing, new or enlarging T2-hyperintense, and new T1-hypointense lesions and brain parenchymal fraction were measured from annual scans obtained at baseline, 1 year, and 2 years. RESULTS: Compared with placebo, natalizumab produced a 92% decrease in Gd-enhancing lesions (means 2.4 vs 0.2; p < 0.001), an 83% decrease in new or enlarging T2-hyperintense lesions (means 11.0 vs 1.9; p < 0.001), and a 76% decrease in new T1-hypointense lesions (means 4.6 vs 1.1; p < 0.001) over 2 years. Median T2-hyperintense lesion volume increased by 8.8% in the placebo group and decreased by 9.4% in the natalizumab group (p < 0.001); median T1-hypointense lesion volume decreased by 1.5% in the placebo group and decreased by 23.5% in the natalizumab group (p < 0.001). Brain atrophy was greater in year 1 and less in year 2 in natalizumab-treated patients. CONCLUSION: Natalizumab has a sustained effect in preventing the formation of new lesions in patients with relapsing multiple sclerosis.

Original languageEnglish
Pages (from-to)1390-1401
Number of pages12
Issue number17
StatePublished - Apr 2007


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