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Published on: April 14, 2014
Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
John DeLuca1, Sven Schippling2, Xavier Montalban3
1Kessler Foundation, 1199 Pleasant Valley Way, West Orange, NJ 07052 USA and Departments of Physical Medicine and Rehabilitation, and Neurology, Rutgers - New Jersey Medical School, Newark 07103, NJ, USA.
Ozanimod demonstrated modest benefits for cognitive processing speed (CPS) in relapsing multiple sclerosis (RMS) patients compared to interferon beta-1a. These findings suggest ozanimod may improve cognitive function in individuals with RMS.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Cognitive dysfunction, specifically slowed cognitive processing speed (CPS), is a significant disabling symptom in multiple sclerosis (MS).
- The Symbol Digit Modalities Test (SDMT) is a key clinical tool for assessing CPS in MS clinical trials and patient screening.
- Ozanimod, a sphingosine 1-phosphate receptor modulator, was investigated for its effects on CPS in relapsing multiple sclerosis (RMS).
Purpose of the Study:
- To compare the efficacy of ozanimod versus intramuscular interferon beta-1a in improving cognitive processing speed (CPS) in RMS patients.
- To conduct post hoc, exploratory analyses of SDMT results from the phase 3 SUNBEAM trial.
Main Methods:
- The phase 3 SUNBEAM study randomized 1,346 RMS participants to daily oral ozanimod (0.92 or 0.46 mg) or weekly intramuscular interferon beta-1a.
- Cognitive processing speed (CPS) was assessed using the Symbol Digit Modalities Test (SDMT) as a secondary endpoint over 12 months.
- Exploratory analyses examined SDMT score changes, clinically meaningful improvements, and the relationship between SDMT performance and brain volume changes.
Main Results:
- Ozanimod treatment resulted in improved SDMT scores compared to interferon beta-1a at both 6 and 12 months.
- A higher percentage of participants receiving ozanimod 0.92 mg experienced clinically meaningful SDMT improvements at months 6 (30.0% vs 22.2%) and 12 (35.6% vs 27.9%).
- Brain volume loss was comparable between participants with SDMT improvement and worsening at 12 months.
Conclusions:
- Ozanimod showed modestly beneficial effects on cognitive processing speed (CPS) in participants with RMS.
- Further evaluation of ozanimod's effects on SDMT performance is ongoing in a 3-year clinical trial.
- The SUNBEAM study is registered on clinicaltrials.gov (NCT02294058) and EudraCT (2014-002320-27).

