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Of the 243 patients screened,150 met our eligibility criteria and were randomly assigned IVIg or placebo.Before the start of treatment two patients in the placebo group dropped out,so there were 75 patients in the IVIg group and 73 in the placebo group.Intention-to-treat analysis showed that IVIg treatment had a beneficial effect on the course of clinical disability.The EDSS score decreased in the IVIg-treated patients and increased in the placebo group(-0.23(95%CI-0.43 to-0.03)vs 0.12(-0.13 to 0.37),p=0.008).In the IVIg group,the numbers of patients with improved, stable,or worse clinical disability were 23(31%),40(53%),and 12(16%) compared with ten(14%),46(63%),and 17(23%)in the placebo group.Side- effects were reported in three(4%)IVIg-treated patients and in four(5%) placebo-group patients,but were not directly linked to study medication. Monthly IVIg is an effective and well-tolerated treatment for patients with relapsing-remitting multiple sclerosis. |
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