Safety, Efficacy of Novel Oral Therapy for Relapsing MS
Treatment-emergent adverse events were mild, and occurred at similar rates across all 3 treatment arms.
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Once-daily ozanimod treatment is safe and efficacious in patients with relapsing multiple sclerosis (MS), according to data presented at the 2018 ACTRIMS Form, held February 1-3 in San Diego, California.
Investigators overseeing the SUNBEAM Trial (Phase 3 Study of RPC1063 in Relapsing MS; ClinicalTrials.gov Identifier NCT02294058) compared the safety of once-daily ozanimod with 30 μg weekly of intramuscular interferon β-1a (IFN) for relapsing multiple sclerosis. SUNBEAM is one of two phase 3 clinical trials examining this comparison.
Primary study end point was annualized relapse rate. Secondary end points included magnetic resonance imaging (MRI) evaluation of new or enlarging T2 lesions or gadolinium enhancing T1 lesions at 12 months and brain volume loss from baseline to 12 months.
Patients with relapsing MS (n=1346) received either 0.5 or 1 mg oral ozanimod daily with 7-day dose escalation for ≥12 months or IFN therapy. Annualized relapse rate was reduced in the ozanimod 0.5 and 1 mg groups (0.241 and 0.181; P =.0013 and P <.0001, respectively). Adjusted mean number of new or enlarging T2 lesions and gadolinium enhancing T1 lesions was also reduced in the ozanimod 0.5 and 1 mg groups (25% and 34% reduction of T2 lesions; 48% and 63% reduction of T1 lesions, respectively). Ozanimod 1 mg “significantly” slowed brain volume loss (32.5%; P <.0001).
Serious treatment-emergent adverse events rates were low across all 3 groups (3.5%, 2.9%, and 2.5% in the ozanimod 0.5 mg, 1 mg, and IFN groups, respectively). Treatment discontinuation rates were lower in the ozanimod 0.5 mg group (1.5%).
“Both ozanimod doses demonstrated superior efficacy vs IFN on relapse and MRI endpoints, including [brain volume loss],” the researchers concluded. “These efficacy, safety, and tolerability results demonstrate that ozanimod is a novel oral therapy with a favorite benefit-risk profile for patients with [relapsing MS].”
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Comi G, Arnold DL, Cree BAC. Ozanimod demonstrates efficacy and safety in a phase 3 trial of relapsing multiple sclerosis (SUNBEAM). Presented at: ACTRIMS Forum 2018. February 1-3, 2018; San Deigo, California. Abstract P023