|The following article is part of conference coverage from the 2018 American Academy of Neurology Annual Meeting in Los Angeles, California. 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 AAN 2018.|
LOS ANGELES — Once-daily immunomodulator ozanimod was demonstrated to be superior to interferon (IFN) β-1a in relapsing multiple sclerosis, according to research presented at the 70th annual American Academy of Neurology meeting, held April 21-28, 2018, in Los Angeles, California.
SUNBEAM (ClinicalTrials.gov Identifier: NCT02294058) was a randomized, multicenter, double-dummy, double-blind, active-controlled, phase 3 clinical trial of the safety and efficacy of ozanimod in relapsing multiple sclerosis. Ozanimod selectively targets sphingosine 1-phosphate receptors 1 and 5. SUNBEAM evaluated ≥12 months of treatment with oral ozanimod 1 mg or 0.5 mg (7-day dose escalation) vs IFN β-1a 30-mg intramuscular injection. The study’s primary end point was annualized relapse rate (RR) over the course of treatment, with secondary end points being disability progression (pooled with another phase 3 study), T2 and gadolinium-enhancing lesions (12 months), and brain volume loss (baseline to 12 months).
The baseline characteristics of the 1346 participants were similar across all arms of the study. Ozanimod 1 mg and 0.5 mg (0.181; P<.0001 and 0.241; P=.0013) were found to reduce the adjusted annualized RR better than IFN β-1a (0.350). The adjusted mean number of gadolinium-enhancing lesions was reduced by 63% for the ozanimod 1-mg group and 34% for the ozanimod 0.5-mg group (0.160; P<.0001 and 0.287; P=.0182) vs the IFN β-1a group (0.433). The adjusted mean number of new or enlarging T2 lesions was reduced 48% for the ozanimod 1-mg group and 25% for the ozanimod 0.5-mg group (1.465; P<.0001 and 2.139; P=.0032) vs the IFN β-1a group (2.836).
All treatment groups demonstrated low confirmed 3-month pooled disability progression (0.102, 0.080, and 0.099, respectively). Volume loss of cortical gray matter was slowed significantly for both ozanimod doses (1 mg, 83.8%; 0.5 mg, 61.4%; both P<.0001); a similar slowing of thalamic volume loss was also noted with both ozanimod doses (1 mg, 38.5%; 0.5 mg, 34.3%; both P=.0001). Whole brain volume loss was significantly slowed by ozanimod 1mg vs IFN β-1a (32.5%, P<.0001); a less-robust slowing was noted for the ozanimod 0.5-mg dose (12.3%, P=.0615).
Patients treated with ozanimod experienced fewer adverse events than those treated with IFN β-1a. The incidence of serious adverse events was balanced across all treatment arms. There were no reports of first-dose, clinically significant heart rate reduction or second-degree or higher atrioventricular block.
The study investigators concluded that, “Both ozanimod doses demonstrated superiority to IFN β-1a on ARR and MRI endpoints, including [brain volume loss]. These efficacy and safety/tolerability results demonstrate oral ozanimod has a favorable benefit-risk profile in [relapsing multiple sclerosis].”
This study was supported by Celgene.
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Comi G, Arnold D, Cree B, et al. Ozanimod demonstrates efficacy and safety in a multicenter, randomized, double-blind, double-dummy, active-controlled phase 3 trial of relapsing multiple sclerosis (SUNBEAM). Poster presented at: 2018 AAN Annual Meeting; April 21-27, 2018; Los Angeles, CA. Poster 396.