Introduction
Multiple sclerosis (MS) is a chronic, progressive neurological disease with many potential symptoms and adverse outcomes. The disease affects approximately 2.3 million people worldwide, with a prevalence of about 1 in 1000. MS causes many symptoms, including muscle weakness, fatigue, problems with balance and coordination, and cognitive impairment. The disease also leads to more serious outcomes, such as blindness, paralysis, and even death. MS can significantly impact a patient’s quality of life and can be very disabling. The current standard of care for relapsing multiple sclerosis is interferon beta-1a. The gaps in current therapy for relapsing multiple sclerosis (RMS) are the lack of disease-modifying treatments that are both effective and well tolerated. There is also a need for treatments that can slow disease progression and improve the quality of life for patients with RMS; hence, the options are limited. The assigned drug works by blocking the action of a protein called sphingosine-1-phosphate, which is involved in the inflammation and damage seen in multiple sclerosis.
Clinical Trial Summary
The trial is a randomized, double-blind, placebo-controlled study lasting 24 months. A total of 1,346 patients with relapsing multiple sclerosis will enroll in the study and be randomly assigned to receive either the assigned drug or a placebo (Cohen et al., 2019). The study’s primary outcome measure is the number of relapses experienced by patients over the course of the study. Secondary outcome measures include the number of new or enlarging lesions on brain MRI, the number of patients who experience disability progression, and the number of patients who experience adverse events.
The Patients enrolled were either 18 years or older, had a relapsing form of MS, and had an Expanded Disability Status Scale (EDSS) score of 2.0–6.5. Patients were also excluded if they had an active infection, a history of malignancy, or any other condition that could have interfered with the trial. The interventions in this study were ozanimod versus interferon beta-1a, and the controls were either placebo or active control.
The primary outcome measure was the number of new or newly enlarged T2-weighted brain lesions on magnetic resonance imaging (MRI) at month 12 (Cohen et al., 2019). Key secondary outcome measures included the number of new T1 lesions, the number of gadolinium-enhancing T1 lesions, the change from baseline in brain volume, the score on the Expanded Disability Status Scale (EDSS), and the number of relapses. Safety outcome measures included the incidence of adverse events, laboratory abnormalities, and serious adverse events.
The study’s primary outcome was the number of new or newly enlarged T2 hyperintense lesions on brain MRI over 24 months. The results showed that ozanimod was more effective than interferon beta-1a in reducing the number of new or newly enlarged T2 hyperintense lesions (p<0.0001). The key secondary outcomes included the number of gadolinium-enhancing lesions on brain MRI, new or newly enlarged T1 hypointense lesions on brain MRI, changes in brain volume, and annualized relapse rate. The results showed that ozanimod was significantly more effective than interferon beta-1a in reducing the number of gadolinium-enhancing lesions (p=0.0003), the number of new or newly enlarged T1 hypointense lesions (p=0.0016), and the annualized relapse rate (p=0.0002) (Cohen et al., 2019). There was no significant difference between the two groups in the change in brain volume over 24 months. The safety profile of ozanimod was similar to that of interferon beta-1a. The most common adverse events were upper respiratory tract infections, nasopharyngitis, and headaches.
Conclusion
The authors conclude that ozanimod was associated with significantly lower relapse rates and fewer new or newly enlarged T2 lesions compared with interferon beta-1a in patients with relapsing MS. Ozanimod was also associated with lower levels of disability progression and fewer brain volume losses. These findings suggest that ozanimod may be a more effective and safer treatment option for patients with relapsing MS.
Reference
Cohen, J. A., Comi, G., Selmaj, K. W., Bar-Or, A., Arnold, D. L., Steinman, L., Hartung, H.-P., Montalban, X., Kubala Havrdová, E., Cree, B. A. C., Sheffield, J. K., Minton, N., Raghupathi, K., Huang, V., & Kappos, L. (2019). Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomized, 24-month, phase 3 trial. The Lancet Neurology, 18(11), 1021–1033. https://doi.org/10.1016/s1474-4422(19)30238-8
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