Adults with relapsing multiple sclerosis (MS) who are treated with ozanimod have less gray matter volume loss than patients treated with interferon, according to a post hoc analysis from the phase 3 RADIANCE Part B trial. The research was presented at the 2019 American Academy of Neurology Annual Meeting.
Adults with relapsing multiple sclerosis (MS) who are treated with ozanimod have less gray matter volume loss than patients treated with interferon, according to a post hoc analysis from the phase 3 RADIANCE Part B trial. The research was presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10 in Philadelphia, Pennsylvania.
RADIANCE is a multicenter, randomized, double-blind study of patients between the ages of 18 and 55 years with relapsing MS. The participants received either oral ozanimod (0.92 mg or 0.46 mg) once daily or intramuscular interferon b-1a 30 mg weekly. In the post hoc analysis, the researchers evaluated the treatment effect on brain volume changes of 0.92 mg oral ozanimod versus interferon by patient age.
“Brain volume loss is associated with long-term physical disability and cognitive issues in multiple sclerosis,” Bruce Cree, MD, PhD, MAS, professor, Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences; Clinical Research Director at the UCSF MS Center; and an author of the analysis, said in a statement. “Ozanimod reduced the loss of cortical gray matter volume across all age groups in this study.”
The 874 patients were separated into 3 age groups: 18 to 25 years (n = 146), 25 to 34 years (n = 265), and 35 years and older (n = 463). The treatment effect on brain volume, including thalamic volume and cortical gray matter, was evaluated at baseline, 12 months, and 24 months.
Patients 25 years or younger had greater brain volume at baseline, but greater brain volume loss by 12 and 24 months. In all 3 age groups, the patients treated with ozanimod had less cortical gray matter volume loss at 12 and 24 months compared with patients treated with interferon. Younger participants in the interferon group had greater gray matter volume loss than older participants, but in the ozanimod group there were not differences by age.
The most common adverse reactions that occurred at a higher rate in patients treated with ozanimod than in patients treated with interferon were upper respiratory tract infections, urinary tract infections, increases of alanine aminotransferase, and increases of gamma glutamyl transferase.
“Since loss of brain volume can be associated with disease progression, there is a need for early diagnosis and treatment in multiple sclerosis,” said Alise Reicin, MD, president, Global Clinical Development, Celgene. “This analysis adds to growing evidence supporting the potential use of ozanimod to treat adults with relapsing multiple sclerosis, including the youngest patients studied, who also showed the most rapid loss in brain volume in this study.”
Schippling S, Cree BAC, Montalban X, et al. Gray matter volume loss is increased in younger patients with relapsing multiple sclerosis but minimized by ozanimod: experience from the ozanimod phase 3 program. Presented at: American Academy of Neurology 2019 Annual Meeting; May 4-11, 2019; Philadelphia, Pennsylvania. Abstract S2.059.