Abstract
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.
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