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Data demonstrate a long-term, positive effect of the drug on cognitive function in patients with multiple sclerosis.
John DeLuca, PhD
Continuous treatment with ozanimod (Zeposia; Celgene) is associated with long-term improvements in information processing speed as measured by the Symbol Digits Modalities Test (SDMT), according to data presented at the 2020 Consortium of Multiple Sclerosis Centers Virtual Annual Meeting.1
Findings from the phase 3 SUNBEAM (NCT02294058) trial and the DAYBREAK extension study (NCT02576717) further demonstrate the benefits of sustained treatment with the oral sphingosine 1-phosphate receptor modulator, which was recently FDA-approved in March 2020 for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.2
In this analysis, John DeLuca, PhD, senior vice president for research and training and interim director of the Center for Stroke Rehabilitation Research at Kessler Foundation, professor in the Departments of Physical Medicine & Rehabilitation (PM&R), and the Department of Neurology at Rutgers New Jersey Medical School, and colleagues sought to evaluate the long-term effects of ozanimod treatment on information processing speed in patients with relapsing MS.
Patients enrolled in the double-blind, double-dummy SUNBEAM trial were randomly assigned to receive once-daily oral ozanimod HCl 1 mg or 0.5 mg, or weekly intramuscular interferon-beta 1a (IFN) 30 µg for 12 months. Following completion of SUNBEAM, participants were eligible to enroll in DAYBREAK which evaluated ozanimod HCl 1 mg. Those who received IFN in SUNBEAM were transitioned to ozanimod 12 to 24 months after SUNBEAM baseline.
Of the 447 patients randomly assigned to ozanimod HCl 1 mg and 448 assigned to IFN in SUNBEAM, 397 and 395 transitioned to DAYBREAK, respectively, with mean baseline SDMT scores of 47.7 and 47.1. At 12 months, 35.6% and 27.9% of patients in the ozanimod and IFN groups experienced clinically meaningful improvement (≥4 point) in SDMT, while 22.0% and 28.2%, respectively, worsened. At 24 months, 41.2% and 34.5% of those who received continuous treatment with ozanimod HCl 1 mg or who transitioned from IFN, respectively, saw improvement in SDMT scores while 21.9% and 25.4%, respectively, worsened relative to their SUNBEAM baseline values.
Change in the SDMT end point is currently being further evaluated in the ongoing multicenter, open-label ENLIGHTEN study (NCT04140305), in which the primary end point is clinically meaningful change in SDMT (≥4-point or 10% change from baseline) over a 3-year period in patients with early relapsing MS being treated with ozanimod HCl 1 mg.3
The study, which will also be led by senior author DeLuca, will enroll 250 adults with relapsing MS who have a diagnosis based on the 2010 or 2017 McDonald criteria, are 5 or less years out from initial diagnosis, are taking no more than 1 disease-modifying therapy, have an Expanded Disability Status Scale score of 3.5 or less, and have no history of relapse within 30 days of screening.
The study will also evaluate changes in whole brain and substructure volume, MRI measures of disease activity, patient-reported outcomes and quality of life, and disability status based on the Timed 25-Foot Walk, 9-Hole Peg Test, and Expanded Disability Status Scale, as well as correlations between changes in cognitive processing speed and brain volume and quality of life outcome measures.
1. DeLuca J, Cohen JA, Cree BAC, et al. Effects of ozanimod on information processing speed: findings from the phase 3 SUNBEAM and DAYBREAK extension trials. Int J MS Care. 2020;22(2 Suppl). Abstract DXT38.
2. US Food and Drug Administration approves Bristol Myers Squibb’s Zeposia (ozanimod), a new oral treatment for relapsing forms of multiple sclerosis. News release. Briston Myers Squibb Company. March 26, 2020. https://www.finance.yahoo.com/news/u-food-drug-administration-approves-103000096.html
3. Riolo JV, Yang L, Rano T, et al. Effect of the S1P1/5 receptor modulator ozanimod on cognitive processing speed in subjects with relapsing multiple sclerosis: design of the ENLIGHTEN study. Int J MS Care. 2020;22(2 Suppl). Abstract DXT40.