While the common first-line disease modifying therapy for remitting relapsing multiple sclerosis (RRMS), interferon (IFN) β-1a, effectively slows progression of the disease for many patients, the side effects and high rate of drug resistance continues to motivate the search for additional treatments.
On October 28, an international team of researchers will present the results of the RADIANCE trial at the 2017 European Committee for Treatment and Research in Multiple Sclerosis in Paris (LBA280), which indicate that a new option for patients with RRMS may be on the horizon.
Multiple sclerosis. (Source: Getty Images)
RADIANCE is the second largest phase 3 clinical trial to compare daily oral ozanimod to interferon (IFN) β-1a. Ozanimod, an immunomodulator, targets sphingosine 1-phosphate 1 and 5 receptors.
The 2-year multicenter, double-blind, parallel-group, active treatment-controlled study enrolled 1,313 patients who were randomized to 1 mg ozanimod, 0.5 mg ozanimod or interferon (IFN) β-1a. Participants had an average age of 36, 67% were female and 29% had previously been treated with a disease-modifying therapy. Mean expanded disability status scale was 2.55, mean number of prior year relapses was 1.3 and 43% had GdE lesions.
The researchers reported lower annualized relapse rates (ARR) on both doses of ozanimod, 0.172 for the 1 mg dose and 0.218 for the 0.5 mg dose, compared to interferon (IFN) β-1a, which had an ARR of 0.276. Both doses were also associated with a lower adjusted mean number of new or enlarged T2 lesions detected per scan, 1.848 for the 1 mg dose and 2.082 for the 0.5 mg dose, versus 3.183 for interferon (IFN) β-1a. Patients taking ozanimod had about half the mean number of GdE lesions at 24 months as those receiving interferon (IFN) β-1a, 0.175-0.196 versus 0.373. All groups had similar rates of adverse events and discontinuation.