Background: Multiple sclerosis (MS) is an autoimmune disorder characterized by inflammatory, demyelinating lesions in the central nervous system. Open studies and experimental evidence suggest beneficial effects of intravenous immunoglobulin (IVIG) by immunomodulating mechanisms and induction of remyelination. Patients and Methods: In this randomized, double-blind, placebo-controlled multicenter trial we tested the efficacy of monthly IVIG in 150 patients with relapsing MS. Primary outcome measures were the effect on clinical disability as measured by the Expanded Disability Status Scale (EDSS), and the proportion of patients with improved, stable or worsened clinical disability (change by ≧?1.0 EDSS point) in each treatment group. Secondary outcome measures included the annual relapse rate and the proportion of relapse-free patients. IVIG was given over 2 years in a monthly dosage of 0.15–0.2 g/kg body weight. Results: As shown by intent-to-treat analysis, the EDSS significantly decreased in the IVIG-treated patients (–0.23 ??0.89) and increased in the placebo-treated patients (+0.12 ??1.07). The difference between both groups was statistically significant (p = 0.008). In the IVIG group 31% of the patients showed improved, 51% stable, and 16% worsened clinical disability. In the placebo group this distribution was 14%, 63% and 23%, respectively (p = 0.041). Annual relapse rates were 0.52 ??0.85 in the IVIG and 1.26 ??2.2 in the placebo group (p = 0.0037). The proportion of relapse-free patients receiving IVIG was 53% vs. 36% of patients in the placebo group (p=0.03). Adverse events occurred in 4% of patients in the IVIG group and in 5% of patients receiving placebo and did not appear to be directly related to the medication. Conclusion: This study demonstrates that monthly IVIG at a dosage of 0.15–0.2 g/kg body weight improves clinical disability and reduces the frequency of relapses without major side effects in relapsing MS.

This content is only available via PDF.
© 1999 S. Karger GmbH, Freiburg
1999
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.