IntraVenous ImmunoGlobulin may effectively and safely reduce the frequency of relapses in patients with Relapsing/Remitting Multiple Sclerosis (RR/MS), according to finding from a double-blind study.
Investigators randomized 40 RR/MS patients (ages, 19-60 years) to receive a loading dose of ImmunoGlobulin IgG (0.4 g/kg/body weight per day over 5 consecutive days) or placebo once every 2 months for a 2-year period.
Main outcomes measures included change in yearly exacerbation rate (YER), proportion of patients free of exacerbation, and time to first exacerbation; secondary outcome measures included neurologic disability, exacerbation severity, and changes in MRI lesion score.
YER was reduced from 1.85 at baseline to 0.75 at 1 year and 0.42 at 2 years among patients receiving IVIg; in comparison, YER changed from 1.55 at baseline to 1.8 at 1 year and 1.4 at 2 years among patients receiving placebo (P=.0006).
Overall, patients receiving IVIg experienced a 38.6 percent reduction in YER. Throughout the 2-year study period, 6 patients receiving IVIg remained free of exacerbations, versus none of the patients receiving placebo.
Median time to first relapse among IVIg patients was 233 days, compared to 82 days among placebo patients (P=.003). EDSS score fell by 0.3 in the IVIg group, and increased by 0.15 in the placebo group.
No significant difference was seen between groups in terms of total lesion score. Adverse events occurred in only 3.0 percent of infusions administered in both groups, and were characterized as "minor."
The authors concluded, "IVIg has a significant benefit in reducing exacerbations in RR/MS patients and hence should be considered as a relapse-preventing therapy."