Efficacy and Safety of Ozanimod in Patients with Early Relapsing Multiple Sclerosis: Year 1 Interim Analysis of the ENLIGHTEN Study
Robert T. Naismith1, Mark Gudesblatt2, Thomas P. Leist3, Robert Zivadinov4, John DeLuca5, Sarah A. Morrow6, Ann D. Bass7, Emily Riser8, Jon V. Riolo9, Amanpreet Kaur9, James Appio9, Massimiliano Cristofanilli9, Ahmed Zayed Obeidat10
1Washington University School of Medicine, 2NYU Langone South Shore Neurologic Associates, 3Thomas Jefferson University, 4Buffalo Neuroimaging Analysis Center, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, 5Kessler Foundation, 6London Health Sciences Centre, University Hospital, University of Western Ontario, London, Ontario, Canada, and Department of Clinical Neurological Sciences, Hotchkiss Brain Institute, University of Calgary, 7Neurology Center of San Antonio, 8Alabama Neurology Associates, 9Bristol Myers Squibb, 10Medical College of Wisconsin
Objective:
This interim analysis describes the efficacy and safety profile of ozanimod over 1 year.
Background:
ENLIGHTEN is an ongoing 3-year study of ozanimod in patients with early relapsing multiple sclerosis (RMS).
Design/Methods:
ENLIGHTEN (NCT04140305) is a multicenter, single-arm, open-label study of ozanimod 0.92 mg in adults with early RMS (≤ 1 disease-modifying therapy [DMT]; Expanded Disability Status Scale [EDSS] score ≤3.5; ≤5 years since RMS diagnosis; ≤10 gadolinium-enhancing [GdE] lesions). The proportion of patients with an increase in Symbol Digit Modalities Test (SDMT) score of ≥4 points (pt) or 10% from baseline was assessed at 1 year, along with clinical and radiologic endpoints. Treatment-emergent adverse events (TEAEs) were assessed through data cutoff (Feb 7, 2024).
Results:
Mean (standard deviation [SD]) ozanimod exposure among 188 enrolled patients was 22.0 (9.4) months (344.1 person-years total exposure). At baseline, mean (SD) SDMT score was 53.4 (12.0), T2 lesion count (n=187) was 22.3 (16.8), and GdE lesion count (n=187) was 0.8 (1.6). After 1 year of ozanimod, 81/168 (48.2%) had ≥4-point or 10% improvement in SDMT. Annualized relapse rate was 0.07 (95% CI [confidence interval], 0.05‒0.11) and 81.9% of patients remained relapse-free. At 1 year, mean (95% CI) new/enlarging T2 lesions per scan was 0.57 (0.39‒0.84) and 93.2% of patients were GdE lesion free. TEAEs occurred in 153 (81.4%) patients; the most common were COVID-19 (25.0%), headache (11.7%), urinary tract infection (10.6%), and fatigue (10.1%). Serious TEAEs occurred in 13 (6.9%) patients; 6 (3.2%) patients discontinued due to TEAEs.
Conclusions:
Improvements in SDMT scores (≥4 points or 10%) as well as clinical and radiologic outcomes were demonstrated after 1 year of ozanimod. Rates of serious TEAEs and TEAEs leading to discontinuation were low, and the safety profile was consistent with the overall ozanimod clinical development program.
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