Multiple Sclerosis Drug Demonstrates Sustained Efficacy in 2-Year Extension Study
Ozanimod reduced the number of brain lesions and lowered relapse rates in patients with relapsing multiple sclerosis.
In a 2-year extension study, treatment with ozanimod effectively reduced disease activity in patients with relapsing-remitting multiple sclerosis (MS), according to data from the phase 2 study.
Ozanimod (Celgene) is an oral immunomodulatory drug that selectively targets sphingosine 1-phosphate receptors 1 and 5, blocking the mobilization of immune cells involved in the inflammatory attacks on nerve fibers and myelin sheaths.
For the clinical trial, the researchers evaluated the efficacy, safety, and tolerability of the treatment in relapsing MS in the 2-part study.
The RADIANCE Part A trial included patients with relapsing MS who were treated with either once-daily ozanimod hydrochloride (0.5 mg or 1 mg) or a placebo. In this part of the trial, treatment with ozanimod reduced the number of brain lesions, as determined by magnetic resonance imaging, from week 12 to week 24. Ozanimod also lowered the frequency of relapses compared with a placebo, according to the study.
Approximately 98% of enrolled patients completed the first part of the trial. Ozanimod was observed to be safe and well-tolerated, with primarily mild adverse effects.
After 24 weeks, patients could enter a 2-year, dose-blinded extension study, in which ozanimod-treated patients continued their assigned dose and placebo-treated patients were re-randomized to ozanimod hydrochloride 0.5 or 1 mg.
Overall, 223 of the 249 patients completed the blinded extension study, with 112 on the lower dose and 111 on the higher dose. At 2 years, 86.5% to 94.6% of patients were gadolinium-enhancing lesion-free. Additionally, the number of T2 lesions remained low in patients treated with ozanimod continuously and dropped in patients who switched from placebo to ozanimod.
Patients already receiving ozanimod maintained low relapse rates and those starting ozanimod in the extension phase showed a decrease in annualized relapse rates. Overall, relapse rates were approximately 0.3% in the 0.5 mg group and 0.18% in the 1 mg group at the end of the extension phase.
Additionally, treatment with ozanimod over the 2-year period was well tolerated, with few patients discontinuing for adverse effects or safety reasons.
“Ozanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo,” the researchers concluded in the study.
The trial results were published in the Multiple Sclerosis Journal.
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Cohen JA, Comi G, Arnold DL, et al. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase 2 study. Multiple Sclerosis Journal. 2018. https://doi.org/10.1177/1352458518789884