Klinische Neurophysiologie 2006; 37 - A2
DOI: 10.1055/s-2006-939085

Intravenous immunoglobulin treatment for patients with primary or secondary progressive Multiple Sclerosis

I Andresen 1, D Pöhlau 2, H Przuntek 3, P Späth 1
  • 1ZLB Behring AG, Research & Development, Bern
  • 2Kamillusklinik, Department of Neurology, Asbach
  • 3Ruhr-University, Department of Neurology, Bochum

Background: Intravenous immunoglobulin (IVIG) has a number of potential effects that may be beneficial in multiple sclerosis (MS): neutralisation of autoantibodies against myelin proteins, down-regulation of T or B cells or pro-inflammatory cytokines, functional blockade of Fc receptors on macrophages and inhibition of complement activation.

Objective: To evaluate the reduction of progression, functional improvement and safety of low dose immunoglobulin (400mg/kg bodyweight) in patients with secondary and primary progressive MS.

Methods: In this randomised, double-blind, placebo controlled multicenter study 231 patients were included. The patients were stratified for primary (n=34) and secondary chronic progressive (n=197) MS. During the study duration of 24 months they either received IVIG (Sandoglobulin®) or placebo every 4 weeks.

Main inclusion criterion was the Expanded Disability Status Scale (EDSS) ≥3.0 and ≤7.0 at entry, worsening of at least 0.5 EDSS points within 12 months prior to entry and no relapse during this time.

The primary efficacy endpoint was the time from baseline until sustained progression.

Additionally different parameters on neurological impairment, depression, quality of life and cognitive functions (neuropsychological assessment) were compared.

Results: The time to progression (IVIG: 74 weeks, placebo: 61.8 weeks) and the number of patients with sustained progression (IVIG: 48.3%, placebo: 62.6%) were significantly better in the IVIG group (p<0,05). The further analysis of the two subgroups revealed a non significant benefit of IVIG in patients with secondary progressive MS but a significant effect in the small group of patients with primary progressive MS. IVIG was well tolerated and not associated with unexpected adverse events.

Conclusion: This study showed a weak trend towards a beneficial effect of IVIG in secondary and a strong trend in primary progressive MS. Additional clinical studies with different dosages and higher numbers of evaluable patients are needed in order to further establish the efficacy and safety of IVIG in the management of MS.