Relapse, disease worsening similar with ozanimod treatment in relapsing MS

Key takeaways:

• Data were analyzed from 709 participants given ozanimod or interferon in two different trials trials.
• At 6 months, relapse and relapse-related disease worsening were similar with ozanimod treatment.

Those with relapsing forms of multiple sclerosis treated with ozanimod saw relapse-associated worsening and progression-independent relapse activity contributed similarly to disability progression, according to research from ECTRIMS 2023.

“Ozanimod treatment was associated with significantly fewer relapses than interferon beta 1-a in phase 3 relapsing multiple sclerosis trials and provided sustained control of disability progression for up to 5 years in an open-label study,” Massimo Filippi, MD, professor of neurology at Università Vita-Salute San Raffaele in Milan, and colleagues wrote.

Researchers aimed to determine both incidence and predictors of relapse-associated worsening (RAW), as well as progression independent of relapse activity (PIRA), in participants from the RADIANCE and DAYBREAK clinical trials.

In the phase 3 RADIANCE study, participants were treated with ozanimod (Zeposia, Celgene) 0.46 mg or 0.92 mg per day (n = 363) or interferon beta 1-a (IFN) 30 g/wk for 24 months. Those who completed the trial were eligible to enroll in DAYBREAK, an open-label extension, in which they were given ozanimod 0.92 mg (n = 346). Confirmed disability progression (CDP) at 6 months was assessed as an increase of 1 point or more in Expanded Disability Status Scale (EDSS) score from baseline and participants were considered to have RAW if confirmed disability onset occurred at least 90 days after a relapse or PIRA if CDP onset occurred without relapse or less than 90 following relapse.

Results showed that 85.8% of participants were free of 6-month CDP in up to 8 years of follow-up. Among those with CDP, 44.3% and 54.5% of those treated with continuous ozanimod had either RAW or PIRA, 8% had both, while 57.8% and 43.4% of participants who switched from IFN to ozanimod had RAW or PIRA, respectively, with 4.8% registering both.

Additionally, the researchers reported that RAW was observed in 10.7% of the continuous ozanimod cohort and 13.9% of those who switched from IFN to ozanimod; PIRA was observed in 13.2% of the continuous ozanimod group and in 10.4% of those who switched.

“As [multiple sclerosis] is a chronic illness, it is important to identify agents that have demonstrated long-term efficacy and have a well-established, favorable safety profile,” Roland Chen, MD, senior vice president and head, Immunology and Cardiovascular Development, Bristol Myers Squibb, told Healio in an email. “There is a continued unmet need for effective therapies to address smoldering neuroinflammation.”