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Ad Hoc Interim Analysis from ENLIGHTEN Clinical Trial of Zeposia for Early RMS Reveals Promising Cognitive Outcomes

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10/16/2023
practicalneurology.com

In a study presented at the 9th joint meeting of the European and American Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS), researchers provided an interim analysis of data from the ENLIGHTEN (NCT04140305) clinical trial. This ad hoc interim analysis documented the safety and efficacy of Zeposia (ozanimod; Bristol Myers Squibb, New York, NY) over 1 year in participants with early relapsing multiple sclerosis (RMS) and revealed improvement in cognitive processing speed in nearly 50% of participants. 

ENLIGHTEN is a multicenter, single-arm, open label phase 3b clinical trial designed to document any changes in cognitive processing speed over 3 years as measured by the Symbol Digit Modalities Test (SDMT) in adult participants with RMS who receive treatment with Zeposia. Participants enrolled in the trial met the following criteria:

  • Have been diagnosed with RMS within the last 5 years
  • Received < 1 disease modifying therapy
  • Have an Expanded Disability Status Scale (EDSS) score < 3.5
  • On MRI scans, have < 10 gadolinium (Gd)-enhancing lesions

Results of the ad hoc interim analysis of cognitive processing speed revealed that after 1 year of treatment with Zeposia:

  • 47.4% (55/116) had a > 4 point improvement in their SDMT score, which is considered clinically important
  • 25.9% (30/116) had stable SDMT scores
  • 26.7% (31/116) had a > 4 point decrease in their SDMT score

In terms of other outcomes:

  • 91% (91/100) of participants with MRI data were free of Gd-enhancing lesions at 1 year vs 66.5% (123/185) at baseline
  • The most common treatment emergent adverse effects reported included COVID-19 infection, headache, fatigue, urinary tract infection, sinusitis, nasopharyngitis, and muscle weakness

Zeposia is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Researchers for this interim study represented a broad range of institutions, including Washington University School of Medicine; The State University of New York, Buffalo; London Health Sciences Center University Hospital; the Neurology Center of San Antonio; The Medical College of Wisconsin; Alabama Neurology Associates; Hope Neurology MS Center; Bristol Myers Squibb; the Kessler Foundation, and Rutgers-New Jersey Medical School.

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Schedule26 May 2024