Ozanimod Reduces Annual Relapse Rate in Patients with Multiple Sclerosis

Celgene recently announced positive findings from the phase 3 SUNBEAM clinical trial, which assessed the safety and efficacy of ozanimod versus first-line therapy in patients with relapsing multiple sclerosis (RMS), according to a press release.

The investigational selective sphingosine 1-phosphate 1 and 5 receptor modulator was found to improve outcomes among patients with RMS compared with interferon beta-1a (Avonex), according to results presented at MSParis2017.

In the trial, 1346 patients with RMS were treated with ozanimod 1-mg and 0.5-mg for at least 1 year.

The investigators found that there was a significant reduction in annualized relapse rate for both doses of ozanimod compared with patients treated with interferon beta-1a, according to the release.

Treatment with ozanimod was observed to reduce new or growing T2 lesions over 1 year for both doses. A significant reduction in gadolinium-enhanced MRI lesions was also observed for ozanimod 1-mg and 0.5-mg compared with interferon, according to the release.

Notably, brain volume loss was lower in the ozanimod cohorts at 1 year, with whole brain volume loss reduced by 33% in the 1-mg group and by 12% in the 0.5-mg group.

In a pooled analysis of the SUNBEAM and RADIANCE trials, Celgene reports that ozanimod did not reach statistical significance compared with interferon for time to 3-month confirmed disability progression, according to the release; however, a low rate of disability progression was observed in all patients.

The most common adverse events linked to ozanimod were nasopharyngitis, headache, and upper respiratory infection. A small number of patients also experienced alanine aminotransferase increases but it typically resolved without discontinuation. Serious adverse events were similar across all cohorts, according to the release.

The investigators also found that infections and serious infections were similar and that there were no serious opportunistic infections in ozanimod-treated patients.

"People living with relapsing multiple sclerosis are still in need of additional oral treatment options with favorable benefit-risk profiles," said study author Giancarlo Comi, MD. "The SUNBEAM data support the potential of ozanimod as a new therapeutic option in this patient population."