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Quantitative Measurement of Intrathecally Synthesized Proteins in Mice

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Intravenous immunoglobulin in relapsing-remitting multiple sclerosis: a dose-finding trial.

F Fazekas¹, F D Lublin, D Li

¹Department of Neurology, Medical University of Graz, Auenbruggerplatz 22, A-8036 Graz, Austria. franz.fazekas@meduni-graz.at

|July 23, 2008

Summary

Intravenous immunoglobulin (IVIG) did not reduce relapses or MRI activity in patients with relapsing-remitting multiple sclerosis (RRMS). This study questions the effectiveness of IVIG for RRMS treatment.

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Area of Science:

Neurology
Immunology
Clinical Trials

Background:

Previous studies suggested IV immunoglobulin (IVIG) may reduce relapses in relapsing-remitting multiple sclerosis (RRMS).
However, these studies were often small and used varying treatment protocols.
A new formulation, IGIV-C 10%, was investigated for its efficacy and safety in RRMS.

Purpose of the Study:

To evaluate the efficacy of two doses of IGIV-C 10% in suppressing clinical and MRI disease activity in RRMS patients.
To assess the safety profile of IGIV-C 10% in this patient population.

Main Methods:

A multicenter, randomized, double-blind, placebo-controlled trial involving 127 RRMS patients.
Patients received 0.2 g/kg or 0.4 g/kg of IGIV-C 10%, or placebo (0.1% albumin) every 4 weeks for 48 weeks.
Primary endpoint: proportion of relapse-free patients; Secondary endpoint: lesion activity on MRI.

Main Results:

No statistically significant difference in the proportion of relapse-free patients between IVIG and placebo groups after 1 year.
No significant difference in cumulative new active MRI lesions between treatment groups.
Adverse event rates were similar across all groups, indicating good tolerability.

Conclusions:

IV immunoglobulin (IVIG) treatment at doses of 0.2 to 0.4 g/kg did not demonstrate a beneficial effect in RRMS patients.
The findings question the clinical utility of IVIG for managing relapsing-remitting multiple sclerosis.
IVIG was well-tolerated, but efficacy was not substantiated in this trial.