Randomized multicenter trial of natalizumab in acute MS relapses: Clinical and MRI effects
| Autor: | Timothy Vollmer, William A. Sheremata, Paul O'Connor, A. J. Willmer-Hulme, Andrew D. Goodman, M. A. Libonati, Luanne M. Metz, Lael Stone, R. S. Murray |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class Integrin alpha4 Contrast Media Gadolinium Antibodies Monoclonal Humanized Severity of Illness Index law.invention Multiple Sclerosis Relapsing-Remitting Natalizumab Double-Blind Method Randomized controlled trial law Multicenter trial Internal medicine Severity of illness medicine Humans business.industry Multiple sclerosis Antibodies Monoclonal Brain medicine.disease Magnetic Resonance Imaging Surgery Clinical trial Chemotaxis Leukocyte Treatment Outcome Blood-Brain Barrier Acute Disease Monoclonal Corticosteroid Female Neurology (clinical) business medicine.drug |
| Zdroj: | Neurology. 62:2038-2043 |
| ISSN: | 1526-632X 0028-3878 |
| Popis: | Relapses in multiple sclerosis (MS) can cause significant neurologic disability. Natalizumab (Antegren) is a humanized anti-alpha4-integrin antibody that inhibits the trafficking of leukocytes across endothelium by blocking binding of alpha4beta1-integrin to vascular cell adhesion molecule-1.To assess the effects of a single dose of IV natalizumab administered soon after the onset of MS relapses.In this randomized, double-blind, multicenter trial, the effects of a single dose of IV natalizumab administered soon after the onset of MS relapses were assessed. MS patients (n = 180) in acute relapse were randomly assigned to receive a single dose of natalizumab 1 or 3 mg/kg or placebo and were followed for 14 weeks.There was no difference in Expanded Disability Status Scale (EDSS) score change over time between treatment and placebo groups. In all three groups, approximately half of patients showed EDSS improvement after 2 weeks, rising to 67% by 8 weeks. EDSS improved by a mean value of 0.8 point at week 1, 1.2 points at week 4, and 1.6 points at week 8 in the natalizumab group compared with EDSS improvement of 1.0 point at week 1, 1.6 points at week 4, and 1.6 points at week 8 in the placebo group. A significant decrease in Gd-enhancing lesion volume was seen in both active treatment groups at weeks 1 and 3 compared with placebo.A single dose of IV natalizumab did not hasten clinical recovery after relapse, although a significant decrease in Gd-enhancing lesion volume was observed at 1 and 3 weeks after treatment. These MRI findings are consistent with prior studies of natalizumab and support its further investigation as an agent for the treatment of MS. |
| Databáze: | OpenAIRE |
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