A Randomized Placebo-Controlled Trial of Natalizumab for Relapsing Multiple Sclerosis

  • Polman M
  • Lublin F
  • Giovannoni G
 et al. 
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Abstract

Background Natalizumab is the first α4 integrin antagonist in a new class of selective adhesion- molecule inhibitors. We report the results of a two-year phase 3 trial of natalizumab in patients with relapsing multiple sclerosis. Methods Of a total of 942 patients, 627 were randomly assigned to receive natalizumab (at a dose of 300 mg) and 315 to receive placebo by intravenous infusion every four weeks for more than two years. The primary end points were the rate of clinical relapse at one year and the rate of sustained progression of disability, as measured by the Expanded Disability Status Scale, at two years. Results Natalizumab reduced the risk of sustained progression of disability by 42 percent over two years (hazard ratio, 0.58; 95 percent confidence interval, 0.43 to 0.77; P

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Authors

  • Md Polman

  • Fd Lublin

  • G Giovannoni

  • a Wajgt

  • Aw Sandrock

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