TREATMENT EFFECTS OF MONTHLY INTRAVENOUS IMMUNOGLOBULIN ON PATIENTS WITH RELAPSING - REMITTING MULTIPLE-SCLEROSIS - FURTHER ANALYSES OF THEAUSTRIAN IMMUNOGLOBULIN IN MS STUDY

Recently, the Austrian Immunoglobulin in Multiple Sclerosis (AIMS) stu dy showed patients with relapsing - remitting multiple sclerosis to be nefit from repeated administration of intravenous immunoglobulin (IVIg ). To provide a more detailed understanding of IVIg's action we perfor med further analyses on the time course of treatment effects and in re gard to the impact of clinical disability at study entry on patients' response to medication. The AIMS trial was a randomized, placebo-contr olled double blind, multicenter trial. It included 148 patients (IVIg: 75; placebo 73) who suffered from relapsing-remitting MS, were 15-65 years old and scored from 1-6 on the Expanded Disability Status Score (EDSS). IVIg was given over 2 years in a monthly dosage of 0.15-0.2 g/ kg body weight Within the first 6 months of the trial clinical disabil ity of IVIg treated patients improved significantly from a baseline ED SS of 3.33 +/- 1.38 to a score of 3.05 +/- 1.73 (P = 0.002). This impr ovement was retained over the subsequent 18 months of the trial (final EDSS: 3.09 +/- 1.62). In contrast placebo-treated patients showed a s light trend for deterioration over the study period (baseline EDSS: 3. 37 +/- 1.67; final EDSS: 3.49 +/- 1.83). IVIg treatment was associated with a significant reduction of relapses throughout the study which w as independent of the patients' disability at baseline. The observatio n of clinical improvement in the early phase of IVIg medication may su ggest the activation of repair mechanisms such as the promotion of rem yelination while immunoregulatory effects would be expected as the cau se of fewer exacerbations throughout the AIMS study. These hypotheses need to be tested in future trials.