Early use of ozanimod (Zeposia®) was found to improve or preserve cognitive function in patients with relapsing multiple sclerosis (MS), according to a new post hoc analysis from the phase 3 SUNBEAM trial (NCT02294058) and the phase 3 open-label extension (OLE) DAYBREAK trial (NCT02576717).
The analysis showed that the greatest treatment effect was observed in patients with high thalamic volume, with 45.5% of these patients showing improvements in cognitive scores and 34.1% showing preservation of cognition at 48 weeks in the DAYBREAK OLE trial. The new results were presented at the 8th Congress of the European Academy of Neurology (EAN), which took place in Vienna, Austria from June 25 to 28, 2022.
“[MS] can lead to significant, irreversible brain volume loss and decreased cognition if not treated quickly upon diagnosis. These new analyses show the potential of early treatment with Zeposia to help stabilize and even improve cognition in people with [MS] with high brain volume, which is important for doctors and people with [MS],” John DeLuca, PhD, senior vice president of research and training at Kessler Foundation from the Department of Physical Medicine & Rehabilitation and the Department of Neurology at Rutgers New Jersey Medical School in Newark, said in a press release.
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Overall, the analysis revealed that patients with high brain volume, particularly the thalamic volume, performed better on the symbol digit modalities test at baseline than those with low brain volume, and these scores remained stable or improved over 4 to 5 years of treatment with ozanimod.
As previously mentioned, cognitive function improved or was preserved in almost 80% of patients with high thalamic volume. Approximately 66% of patients with low brain volume also had improved (35.6%) or stable (30.7%) cognitive function at month 48 in the OLE trial.
More than 80% of patients (326 out of 399) tolerated treatment with ozanimod starting in the SUNBEAM trial and continuing through month 48 of the DAYBREAK OLE trial.
“We’re excited by the potential effect of Zeposia in protecting cognitive function when used early in treatment before brain volume is lost and what it can mean for individuals with relapsing [MS],” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development at Bristol Myers Squibb.
Bristol Meyers Squibb presents new data showing effect of early Zeposia (ozanimod) treatment in improving and preserving cognitive function in people with relapsing multiple sclerosis. News release. Bristol Meyers Squibb; June 24, 2022.