Qualitative and quantitative volumetric evaluation of the efficacy of intravenous immunoglobulin in multiple sclerosis: preliminary report

We conducted a doubleblind, placebo-controlled study in 13 patients (aged 2 2 to 54 years) with relapsing-remitting multiple sclerosis (MS). They were randomly assigned to receive a loading dose of immunoglobulin IgG, 0.4 g/kg body weight/day for 5 consecutive days, followed by single booster doses o f 0.4 g/kg/day, or placebo, once a month for 9 months. MRI was obtained bef ore and during the 3rd and 6th months of treatment; examinations in the 9th and 12th months were planned. Qualitative and quantitative blinded assessm ents were performed. There were seven patients who received active treatmen t and six who received placebo. Statistical analysis was performed by the W ilcoxon test. A decrease in the size and number of lesions was observed on MRI in five patients (71%) in the treatment group, and in two (33 %) of the placebo group at 3-month follow-up. At 6 months follow-up MRI, a decrease in the amount of lesions was observed in all patients treated with IV IgG, and in two (33 %) of the placebo group; four patients (66 %) receiving plac ebo showed an increase. Quantitative analysis showed a statistically signif icant decrease in the volume of lesions in treatment group at both 3 and 6 month follow-up. There was no statistically significant change in the place bo group.