| Intravenous immunoglobulin treatment following the first demyelinating event suggestive of multiple sclerosis: a randomized, double-blind, placebo-controlled trial. | |
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MedLine Citation:
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PMID: 15477504 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Intravenous immunoglobulin (IVIg) has been reported to reduce disease activity in patients with relapsing-remitting multiple sclerosis. We assessed the effect of IVIg treatment in patients after the first neurological event suggestive of demyelinative disease and evaluated the occurrence of a second attack and dissemination in time demonstrated by brain magnetic resonance imaging within the first year from onset. METHODS: We conducted a randomized, placebo-controlled, double-blind study in 91 eligible patients enrolled within the first 6 weeks of neurological symptoms. Patients were randomly assigned to receive IVIg treatment (2-g/kg loading dose) or placebo, with boosters (0.4 g/kg) given once every 6 weeks for 1 year. Neurological and clinical assessments were done every 3 months, and brain magnetic resonance imaging was performed at baseline and the end of the study. RESULTS: The cumulative probability of developing clinically definite multiple sclerosis was significantly lower in the IVIg treatment group compared with the placebo group (rate ratio, 0.36 [95% confidence interval, 0.15-0.88]; P = .03). Patients in the IVIg treatment group had a significant reduction in the volume and number of T2-weighted lesions and in the volume of gadolinium-enhancing lesions as compared with the placebo group (P = .01, P = .01, and P = .03, respectively). Treatment was well tolerated, compliance was high, and incidence of adverse effects did not differ significantly between groups. CONCLUSIONS: Intravenous immunoglobulin treatment for the first year from onset of the first neurological event suggestive of demyelinative disease significantly lowers the incidence of a second attack and reduces disease activity as measured by brain magnetic resonance imaging. |
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Authors:
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Anat Achiron; Irena Kishner; Ida Sarova-Pinhas; Havi Raz; Meir Faibel; Yael Stern; Mor Lavie; M Gurevich; Mark Dolev; David Magalashvili; Yoram Barak |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Archives of neurology Volume: 61 ISSN: 0003-9942 ISO Abbreviation: Arch. Neurol. Publication Date: 2004 Oct |
Date Detail:
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Created Date: 2004-10-12 Completed Date: 2004-12-03 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0372436 Medline TA: Arch Neurol Country: United States |
Other Details:
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Languages: eng Pagination: 1515-20 Citation Subset: AIM; IM |
Affiliation:
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Multiple Sclerosis Center and Neuroradiology Unit, Sheba Medical Center, Tel-Hashomer 52621, Israel. achiron@post.tau.ac.il |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Brain / pathology Demyelinating Diseases / complications, pathology, therapy* Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Gadolinium / diagnostic use Humans Immunization, Passive Immunoglobulins, Intravenous / therapeutic use* Magnetic Resonance Imaging / methods Male Middle Aged Multiple Sclerosis / etiology, pathology, therapy* Odds Ratio Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Immunoglobulins, Intravenous; 7440-54-2/Gadolinium |
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