|The following article is part of conference coverage from the 2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers in Nashville, Tennesssee. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2018.|
Ozanimod appears to be superior to interferon (IFN) in treating people with relapsing multiple sclerosis (MS); additionally, it shows a positive benefit-risk profile in terms of safety and tolerability.
This research was presented at the 32nd Annual Meeting of the Consortium of Multiple Sclerosis Centers, held May 30-June 1, 2018, in Nashville, Tennessee.
This study analyzed results from SUNBEAM (ClinicalTrials.gov Identifier: NCT02294058) and RADIANCE (ClinicalTrials.gov Identifier: NCT01628393), 2 double-blind, randomized, phase 3 trials. SUNBEAM (1 year) included 1346 subjects with MS, and RADIANCE (2 years) included 1313. In both trials, participants were treated with either IFNβ-1a in a 30 μg dose or ozanimod in a 1 or 0.5 mg dose.
In SUNBEAM, the adjusted annualized relapse rate decreased by 48% with ozanimod 1 mg (0.181; P <.0001) and 31% with ozanimod 0.5 mg (0.241; P =.0013) compared with IFN (0.350). In RADIANCE, it decreased by 38% (0.172; P <.0001) with ozanimod 1 mg and 21% with ozanimod 0.5 mg (0.218; P =.0167) compared with IFN.
There were other favorable differences associated with ozanimod 1 and 0.5 mg compared with IFN. In SUNBEAM, the adjusted mean number of new or growing T2 lesions decreased by 48% (P <.0001) and 25% (P =.0032), respectively. In RADIANCE it decreased by 42% (P <.0001) and 34% (P =.0001).
Other statistically significant decreases were observed in the mean number of gadolinium-enhancing lesions, loss of whole brain volume, and 3-month pooled progression of disability. There were also fewer adverse events, with ozanimod 1 mg at 67.1%, ozanimod 0.5 mg at 65.6%, and IFN at 79.2%, as well as fewer adverse events resulting in study discontinuation. Serious adverse events occurred roughly equally across all groups and were not common.
The study researchers concluded that “[both] ozanimod 1 mg and 0.5 mg demonstrated superiority to IFN on annualized relapse rate and magnetic resonance imaging end points. These findings, coupled with safety/tolerability results, suggest that oral ozanimod has a favorable benefit-risk profile in relapsing MS.”
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Cree BAC, Bar-Or A, Comi G, et al. Efficacy and safety of ozanimod versus interferon beta-1a in two randomized, double-blind, phase 3 studies in relapsing multiple sclerosis (SUNBEAM and RADIANCE Part B). Poster presentation at: 2018 CMSC Annual Meeting. May 30-June 1, 2018; Nashville, TN. Abstract DX69.