cqvip:Background In patients who present with clinically isolated syndromes suggesti ve of multiple sclerosis, interferon beta 1a is effective in delaying evolution to clinically definite disease and in reducing MRI measured disease activity. We aimed to assess whether this drug can also reduce the rate of brain volume de crease in such patients enrolled in the ETOMS (early treatment of multiple scler osis) trial. Methods MRI data for brain volume measurements at baseline, month 1 2, and month 24 were available from 131, 111, and 112 patients assigned treatmen t (22 μg interferon beta 1a), and 132, 98, and 99 patients assigned placebo re spectively. Normalised brain parenchymal volume (NBV) at baseline and percentage brain volume changes (PBVC) were measured with a fully automated segmentation technique. The primary endpoint was conversion to clinically definite multiple s clerosis due to clinical relapse. Analysis was by intention to treat. Findings 4 1 (31%) of 131 patients on interferon beta 1a and 62 (47%) of 132 on placebo converted to clinically definite multiple sclerosis (odds ratio 0.52 [95%CI 0. 3 1-0.86], p=0.0115). Mean PBVC for patients on placebo was -0.83%during the f i rst year, -0.67%during the second year, and -1.68%during the entire study pe riod. Respective values for treated patients were -0.62%, -0.61%, and -1.18 %. The changes in brain volume were significant in both groups at all timepoint s. A significant treatment effect was detected for month 24 versus baseline valu es (p=0.0031). The number of new T2 lesions formed during the first year correla ted weakly with PBVC during the second year. Interpretation Early treatment with interferon beta 1a is effective in reducing conversion to clinically definite multiple sclerosis and in slowing progressive loss of brain tissue in patients w ith clinically isolated syndromes. The modest correlation between newlesion form ation and brain volume decrease suggests that inflammatory and neurodegenerative processes are, at least partly, dissociated from the earliest clinical stage of multiple sclerosis onwards.
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