According to new data, a Phase 3 extension study of Zeposia for multiple sclerosis (MS) found a sustained decrease in brain volume loss over five years.
The open-label extension of the DAYBREAK trial showed that patients treated with Zeposia experienced low and stable rates of brain volume loss. The annualized rate of loss for whole brain volume was -0.27% for patients in the RADIANCE trial and -0.35% for those in the SUNBEAM trial at Month 60.
Furthermore, a separate safety analysis showed declining or stable rates of adverse events over eight years of Zeposia treatment. Rates of infections, serious infections, and opportunistic infections remained relatively low.
“Brain volume loss can lead to significant cognitive decline if MS is not treated early,” said Jeffrey Cohen, an MD and paid consultant for Bristol Myers Squibb. “These new results reinforce the safety and efficacy of Zeposia as an effective treatment for MS.”
The DAYBREAK OLE trial included over 2,250 patients from previous Phase 3 trials. The trial evaluated brain volume loss and compared data from patients switching from interferon beta-1a (IFN-β) to Zeposia. The results showed consistent reductions in brain volume loss rates with Zeposia treatment.
Another finding from the trial was the observation of high annualized loss in cortical grey matter volume with IFN-β, which reversed and showed an increase after switching to Zeposia.
Overall, the new data from the DAYBREAK extension study provides further evidence of the sustained efficacy and safety of Zeposia in treating MS.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
