Robert Zivadinov, MD: The TOPIC Study and Aubagio's Effect on CGMV Loss

Robert Zivadinov, MD, professor of neurology at the University of Buffalo: What's really novel in this study, is that for the first time ever in multiple sclerosis (MS), somebody looked at how the development of cortical gray matter atrophy - which is a very important component of the disease in later stages, but until very recently has been almost unknown in the early stages of the disease - contributes to the development of clinically definite MS.

So there are 2 very important components of this study. The first one is really a biological, and that is when you look at people as a group, whether they have been treated or not treated, and then you look conversion to the clinically definite MS, there was a very high association between people who developed cortical gray matter atrophy and converted during the 2 years of the trial, or in years 3 and 4, to clinically definite MS. So the point I'm making is, I think, of extreme importance, and it’s that cortical disease in these patients, from the first onset, is present already at the first clinical attack and accelerates very much over the 2, 3, or 4 years of the disease to predict clinical outcomes, which is conversion to CDMS.

Now, the second component of the study was, obviously, to look the effect of Aubagio on whether it can or cannot slow down cortical gray matter development, and I think we found very, very strong data that both doses of Aubaguio, 7 and 14 mg, slow down cortical gray matter atrophy with respect to placebo, starting already at 6 months, and continued at months 12, 18, and 24.

Also, we found that when we divided these 3 groups into those who were treated or not treated, there was a much larger proportion of patients who developed less cortical atrophy with Aubagio compared to placebo, and on the other hand, there were many more placebo patients who developed more cortical atrophy, especially higher than 1.8% per year, of cortical atrophy loss then Aubagio patients, and that highly correlated with development of clinically definite MS.