Patients with Multiple Sclerosis Administered Ozanimod Still Mount Response Against COVID-19 After Vaccination

New analyses on serologic responses and clinical outcomes with COVID-19 vaccination in patients with relapsing forms of multiple sclerosis (MS) who were administered ozanimod (Zeposia, Bristol Myers Squibb) showed that more than 92% of all study participants mounted a serological response following vaccination. The findings were from the ongoing phase 3 DAYBREAK open-label extension study.

“These data are of clinical importance for physicians treating multiple sclerosis, because they provide a greater understanding of how COVID-19 infections and vaccinations interplay with Zeposia treatment,” study investigator Bruce Cree, MD, PhD, MAS, professor of Clinical Neurology, University of California San Francisco (UCSF) Weill Institute for Neurosciences and Clinical Research Director, UCSF MS Center, said in a press release. “Regardless of prior COVID-19 exposure, most participants mounted an immune response following COVID-19 vaccination without experiencing adverse events, in contrast to some reports of other S1P modulators that described no response, adding insight to the treatment decision making process.”

Among participants with prior COVID-19 exposure, seroconversion was observed in 100% of individuals following full COVID-19 mRNA or non-mRNA vaccination. COVID-19-related adverse events were reported in 10% of vaccinated participants, none of which were considered serious.

Ozanimod is an oral, sphinogosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. The drug blocks the ability of lymphocytes to egress from lymph nodes, lowering the amount of lymphocytes in peripheral blood. The mechanism that ozanimod exerts therapeutic effects in MS is unknown, but it is possible that it involves the reduction of lymphocyte migration into the central nervous system.

The FDA approved ozanimod for the treatment of adults with relapsing forms of MS in March 2020 and adults with moderately to severely active ulcerative colitis (UC) in May 2021.

DAYBREAK, RADIANCE, and SUNBEAM were analyzed as multiple trials that evaluated the safety and efficacy of ozanimod orally compared with interferon beta-1a over a 12- and 24-month period. In each trial, patients were administered ozanimod 0.92 mg or ozanimod 0.46 mg compared with intramuscular interferon beta-1a.

Data from the ongoing phase 3 DAYBREAK OLE study showed that 68% of participants were relapse-free with an adjusted annualized response rate of 0.099 at up to 74 months of treatment. The trial also found that long-term efficacy MRI measures were consistent after 60 months of treatment, with a mean number of new and enlarging T2 lesions per scan of 0.98, and disability progression in up to 74 months of treatment, with a 6-month confirmed disability progression of 14%.

The trials also showed that a greater proportion of patients administered ozanimod had a lower annualized rate of brain volume loss compared with interferon beta-1a. Among patients continuously treated with ozanimod, individuals with a low annualized rate of brain volume loss (ARBVL) showed higher cognitive processing speed as measured by the mean symbol digits modalities test vs patients with high ARBVL.

“We remain dedicated to pursuing pathbreaking science and collaborating with the scientific and patient communities to deepen our understanding on the use of our medicines and to help individuals with multiple sclerosis live healthier, more fulfilling lives,” said Jonathan Sadeh, MD, MSc, senior vice president of Immunology and Fibrosis Development, Bristol Myers Squibb, in a press release. “Our COVID-19 and disability progression findings, as well as our presentations demonstrating an association between Zeposia use and reduced brain volume loss along with improved cognitive processing speed, reinforce the importance of early intervention in the treatment of multiple sclerosis and Zeposia’s profile in the treatment armamentarium.”

REFERENCE

New Zeposia (ozanimod) Data Highlight COVID-19 Outcomes and Preservation of Long-Term Cognitive Function from Separate Analyses in Patients with Relapsing Forms of Multiple Sclerosis. Bristol Myers Squibb. October 26, 2022. Accessed October 26, 2022. https://news.bms.com/news/corporate-financial/2022/New-Zeposia-ozanimod-Data-Highlight-COVID-19-Outcomes-and-Preservation-of-Long-Term-Cognitive-Function-from-Separate-Analyses-in-Patients-with-Relapsing-Forms-of-Multiple-Sclerosis/default.aspx