We wanted to assess whether intravenous immunoglobulin G (IVIG) decrea
ses disease activity on MRI in relapsing MS. Previous trials of IVIG i
n relapsing-remitting MS demonstrated a reduction of acute relapses, b
ut these studies did not include MRI. We treated 26 patients in a rand
omized, double-blind, crossover study of IVIG 1 g/kg daily or placebo
on 2 consecutive days every month during two 6-month treatment periods
. The primary end point was the number of gadolinium-enhancing lesions
on monthly serial MRI. Secondary efficacy variables were the occurren
ce of exacerbations, clinical neurologic ratings, total MS lesion load
on T2-weighted MRI, and multimodal evoked potentials. Eighteen patien
ts completed the entire trial; eight patients did not. Twenty-one pati
ents completed the first treatment period and at least two MRI examina
tions in the second treatment period and were included in the intentio
n-to-treat analysis. On serial MRI, we observed fewer enhancing lesion
s per patient per scan during IVIG treatment (median, 0.4; range, 0 to
9.3) than during placebo treatment (median, 1.3; range, 0.2 to 25.7;
p = 0.03). During IVIG treatment, 15 patients were exacerbation free c
ompared with only 7 an placebo (p = 0.02). The total number of exacerb
ations in the MG period was 11 and in the placebo period, 19 (not sign
ificant). None of the remaining secondary efficacy measures were signi
ficantly different between the two treatment periods. The number of ad
verse events, in particular eczema, was significantly higher during MG
therapy than during placebo treatment. These results suggest that IVI
G treatment is beneficial to patients with relapsing MS.