Response to COVID-19 Vaccines Confirmed in People With Relapsing Multiple Sclerosis Treated With Ozanimod
In the open-label extension of the DAYBREAK (NCT02576717) trial, participants with relapsing multiple sclerosis (RMS) being treated with ozanimod (Zeposia; Bristol Myers Squibb, New York, NY) developed antibodies in response to mRNA-based vaccines (100% n=80/80) and nonmRNA vaccines (62% n=18/29) against COVID-19.
Increased antibody levels occurred from 4 weeks to more than 12 weeks and were higher with a second vaccination (grand mean 512.6 U/mL, range: 1.3-4572) vs a single dose of vaccine (grand mean 39.3 U/mL, range: 0.4-368.5). These data were presented at the European Academy of Neurology Congress June 25-28 in Vienna and online.
“This study shows that all participants who received Zeposia as a treatment for multiple sclerosis were able to develop an immune response following mRNA vaccinations against COVID-19 infection,” said Bruce Cree, MD, PhD, MAS, study investigator and professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and clinical research director, UCSF MS Center. “Patients treated with Zeposia are much more likely to develop antibody responses to RNA vaccines compared to nonRNA vaccines. This observation may be helpful for physicians as they seek to optimize care for patients in the face of the ongoing COVID-19 pandemic.”
In a separate analysis, presented at the Consortium of Multiple Sclerosis Centers meeting in June 2022, 8.7% of 2,181 people enrolled in DAYBREAK developed confirmed or suspected COVID-19 as of May 2021 and 3 COVID-19-related deaths occurred. Most cases (92.6%) of COVID-19 were not serious, and the majority (62.6%) who developed COVID-19 continued ozanimod treatment with all survivors eventually continuing ozanimod treatment.
“We are committed to partnering with the research and medical communities to understand how our medicines should best be used in the context of the evolving COVID-19 pandemic,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb. “While more research is required, these data further confirm Zeposia’s consistent safety profile and demonstrate that individuals receiving Zeposia for multiple sclerosis mount a measurable antibody response to COVID-19 vaccination.”