Intravenous immunoglobulin treatment following the first demyelinating event suggestive of multiple sclerosis: A randomized, double-blind, placebo-controlled trial

Intravenously administered immunoglobulin (IVIg) treatment has been reported to be beneficial in the treatment of patients with relapsing-remitting multiple sclerosis. The goal of this study was to evaluate the effect of IVIg treatment in patients after the first neurological event suggestive of demyelinative disease. The authors conducted a randomized, placebo-controlled, double-blind study in 91 patients enrolled within the first six weeks of neurological symptoms. All patients had an abnormal MRI. Patients were randomly assigned to receive IVIg treatment (2-g/kg loading dose) or placebo, with boosters (0.4 g/kg) given once every six weeks for one year. Neurological and clinical assessments were done every three months, and brain magnetic resonance imaging was performed at baseline and the end of the study (one year).The cumulative probability of developing clinically definite multiple sclerosis was significantly lower in the IVIg treatment group compared with the placebo group (rate ratio, 0.36 [95% confidence interval, 0.15-0.88]; P = .03). Patients in the IVIg treatment group had a significant reduction in the volume and number of T2-weighted lesions and in the volume of gadolinium-enhancing lesions as compared with the placebo group (P = .01, P = .01, and P = .03, respectively). Treatment was well tolerated, compliance was high, and incidence of adverse effects did not differ significantly between groups. The authors conclude that IVIg treatment for the first year from onset of the first neurological event, suggestive of demyelinative disease, significantly lowers the incidence of a second attack and reduces disease activity as measured by brain magnetic resonance imaging