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A new study has shown that patients treated with Zeposia for relapsing forms of multiple sclerosis (MS) experience sustained reductions in brain volume loss.

Zeposia, whose active ingredient is ozanimod, is prescribed for the treatment of both moderately to highly active ulcerative colitis (UC) and relapsing types of MS in adults.

The drug reduces the size and frequency of brain lesions and lowers MS relapse rates. It is also used to manage UC symptoms and support the induction and maintenance of remission.

The Phase 3 study, coded DAYBREAK, tracked patients over a 60-month period and found minimal and consistent whole brain volume (WBV) loss in those receiving ongoing Zeposia treatment for up to five years.

DAYBREAK was a long-term, open-label extension study conducted across multiple sites, aiming to evaluate the safety and efficacy of Zeposia in patients with relapsing forms of MS.

Patients who qualified from previous trials (RADIANCE, SUNBEAM, and RPC01-1001) involving the drug were enrolled and treated through the completion of DAYBREAK, receiving either 0.92 mg or 1 mg of Zeposia.

Involving 2,257 patients from the SUNBEAM and RADIANCE Phase 3 trials, the DAYBREAK open-label extension (OLE) study focused on brain volume reduction rates.

Zeposia treatment consistently reduced WBV loss compared to interferon beta-1a (IFN-β), with annualized LSM% changes in WBV from DAYBREAK baseline to Month 24 and RADIANCE baseline to Month 24 at −0.48% and −0.19%, respectively, showing similar trends in the SUNBEAM trial.

Comparable decreases were noted in thalamic volume loss.

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Under IFN-β treatment, significant reductions in cortical grey matter volume (CGMV) were observed (annualized change at Month 12 compared to SUNBEAM baseline: −1.02%; at Month 24 compared to RADIANCE baseline: −0.59%). However, this trend reversed 12 months after switching to Zeposia during DAYBREAK, with an increase in annualized LSM%.

These findings will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.

Safety data from the study showed that after more than eight years of treatment, the incidence rates of treatment-emergent adverse events (TEAEs) remained stable or decreased, with relatively low rates of infections, severe infections, and opportunistic infections.

“These new analyses reinforce the well-established safety and efficacy profile of Zeposia as an effective oral therapy, particularly for newly diagnosed patients with relapsing forms of multiple sclerosis,” said Dr. Jeffrey Cohen of the Mellen Center for Multiple Sclerosis.

Multiple sclerosis damages both white and gray matter in the brain, leading to faster brain atrophy compared to individuals without MS.

“The data presented at ECTRIMS further reinforce Zeposia’s long-term safety and efficacy and add to the growing evidence of its potential to slow disease progression over time,” said Alyssa Johnsen, Senior Vice President at Bristol Myers Squibb.

Zeposia is licensed for the treatment of moderately to severely active ulcerative colitis in adults and relapsing forms of multiple sclerosis in adults in many countries worldwide.

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