Updated Study Data for Ozanimod in Relapsing Multiple Sclerosis

Author:

DeLuca John1,Filippi Massimo2,Gold Ralf3,Selmaj Krzysztof4,Zivanidov Robert5

Affiliation:

1. Kessler Foundation, East Hanover, New Jersey, USA; Departments of Physical Medicine and Rehabilitation, and Neurology, Rutgers-New Jersey Medical School, Newark, USA

2. Neuroimaging Research Unit, Division of Neuroscience, Neurology Unit, Neurorehabilitation Unit, and Neurophysiology Service, IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University, Milan, Italy

3. Neurologische Universitätsklinik, St. Josef Hospital, Bochum, Germany

4. Centre for Neurology, Łódź, Poland; Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland

5. Buffalo Neuroimaging Analysis Centre, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, USA

Abstract

Ozanimod is an approved treatment for relapsing multiple sclerosis (RMS) that has been shown to reduce relapses, new brain lesions, and brain volume loss relative to intramuscular interferon (IFN) β-1a. This article summarizes the latest data, and several new analyses, of clinical trials of ozanimod in RMS, which were presented at the 9th Joint European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)-ACTRIMS Meeting in 2023, and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024. ENLIGHTEN is a prospective, open-label study of ozanimod in patients with early RMS (≤5 years after diagnosis of multiple sclerosis [MS]) who have received ≤1 MS disease-modifying therapy (DMT). In an ad hoc interim analysis, conducted after 1 year, cognitive processing speed improved or remained stable in the majority of patients. This suggests that ozanimod may prevent cognitive decline during the first year of use. In addition, decline in whole brain volume (WBV), which is often accelerated in patients with MS, was minimal, indicating that brain volume was preserved during the first year of ozanimod treatment in patients with early RMS. Final data were presented for the completed open-label extension (OLE) study of ozanimod in adults with RMS (DAYBREAK). Long-term follow-up of participants indicated that the majority remained free of confirmed disability progression (CDP), and a post hoc analysis found no evidence of disease rebound in participants who discontinued ozanimod. Ozanimod was generally well tolerated with sustained efficacy over a treatment period of approximately 6 years, demonstrating a low relapse rate and control of disability progression.

Funder

Bristol-Myers Squibb

Publisher

European Medical Group

Reference34 articles.

1. Bristol Myers Squibb (BMS). ZEPOSIA (ozanimod). FDA package insert. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209899s006s009lbl.pdf. Last accessed: 15 April 2024.

2. European Medicines Agency (EMA). Zeposia: EPAR – Product information. 2024. Available at: https://www.ema.europa.eu/en/documents/product-information/zeposia-epar-product-information_en.pdf. Last accessed: 15 April 2024.

3. Tran JQ et al. Results from the first‐in‐human study with ozanimod, a novel, selective sphingosine‐1‐phosphate receptor modulator. J Clin Pharmacol. 2017;57(8):988-96.

4. Cohen JA et al. Efficacy and safety of ozanimod in multiple sclerosis: dose-blinded extension of a randomized phase II study. Mult Scler. 2019;25(9):1255-62.

5. Cohen JA et al. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):373-81.

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