Multiple sclerosis expert, Dr DeLuca, shares study design and clinical data on the association between brain volume and long-term cognition in patients with relapsing MS.
John DeLuca, PhD: This study was presented at the EAN [European Academy of Neurology] meeting in 2022, in Vienna, Austria. The title is, “The Positive Association Between Baseline Brain Volume and Long-Term Cognition in Patients With Relapsing Multiple Sclerosis.” The idea here is looking at brain volume and its relationship to cognitive processing speed over time. Why cognitive processing speed? Cognitive processing speed happens to be the best measure of determining whether there are cognitive problems, particularly early in the disease, because that tends to be the problem that one sees early. You may see cognitive processing problems before you see other areas, like learning and memory. This study looked at early relapsing-remitting patients who were on Zeposia [ozanimod] in a double-blind placebo-controlled trial compared to interferon beta-1a. That initial phase 3 trial looked at the Symbol Digit Modalities Test [SDMT], which is the measure of processing speed.
After that phase 3 trial was over, there was an open-label extension called the DAYBREAK trial, where the individuals who were in the initial interferon beta-1a trial were then switched over to Zeposia, and that was maintained for up to 48 months. The study looked at processing speed over that period of time. The other thing that the study did was looked at brain volume at baseline, and the relationship between how much brain volume there was at baseline or when the study started, and the impact of the Symbol Digit Modalities Test over time. Brain volume was divided into tertiles at baseline, that is high, medium, and low brain volume measures.
In this study, we were looking at individuals who had high brain volume vs low brain volume at baseline. All of these individuals now in the DAYBREAK study were on ozanimod. What we found was individuals who had high brain volume at baseline had significantly higher SDMT scores, scores on cognitive processing speed, compared to those in the low brain volume group. The important point here was that individuals in the high brain volume group actually showed a slight increase in their processing speed over the 48 months. Whereas, the lower brain volume group showed a decline in the number of patients who showed clinically meaningful change on a Symbol Digit Modalities Test.
The idea here is that individuals who were on ozanimod and were in the high brain volume group were able to maintain their processing speed efficiency. That was a significant finding compared to the low brain volume groups, indicating that brain volume at baseline has a significant impact on choosing the medications that one would potentially use in patients if they were thinking about preserving brain volume itself and cognition, particularly cognitive processing speed.
Transcript Edited for Clarity