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Abstract
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.
Footnotes
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↵Supplemental data at www.neurology.org
Received June 1, 2006. Accepted in final form December 19, 2006.
Disclosures: The AFFIRM study was sponsored by Biogen Idec and Elan Pharmaceuticals. Profs. Miller, Hutchinson, and Giovannoni report having received grants (>$10,000) from Biogen Idec for other research or activities not reported in this article as well as honoraria (<$10,000) from Biogen Idec during the course of this study. Prof. Polman reports having received grants (>$10,000) from Biogen Idec for other research or activities not reported in this article and honoraria (<$10,000) from Biogen Idec during the course of this study and has given expert testimony related to the subject of this article. Prof. Kappos reports having received grants (>$10,000) from Biogen Idec for other research or activities not reported in this article. Dr. Fisher reports having received research funding (>$10,000) for other research not reported in this article. Dr. O'Connor, Dr. Barker, and Prof. Havrdova report having received honoraria (<$10,000) from Biogen Idec during the course of this study. Dr. Phillips reports having received grant support (<$10,000) from Biogen Idec for other research/activities not reported in this article and honoraria from Biogen Idec (<$10,000) during the course of this study. Dr. Lublin reports having received honoraria (>$10,000) from Biogen Idec during the course of this study. Dr. Rudick reports having received research funding (>$10,000) for research not reported in this article and honoraria (<$10,000) from Biogen Idec during the course of this study. Ms. Lynn, Dr. Panzara, and Dr. Sandrock have equity interests (>$10,000) and are employees of Biogen Idec. Drs. Soon, Fernando, MacManus, Yousry, and Wajgt report no conflicts of interest.
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