SARS-CoV-2 vaccine response in RMS patients treated with ozanimod and other DMTs

ABSTRACT

Objective: To describe antibody and T-cell responses to the three SARS-CoV-2 vaccines available in the United States (U.S.) in patients with relapsing multiple sclerosis (RMS) on ozanimod or other disease modifying therapies (DMTs). Background: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is a novel, zoonotic coronavirus that emerged in late 2019 in patients with pneumonia of unknown cause;the disease caused by SARS-CoV-2 is termed COVID-19 (coronavirus disease 2019). Recent reports have suggested that RMS patients on certain DMTs may have a blunted humoral response to the available COVID-19 vaccinations. Sphingosine-1-phosphate (S1P) receptor modulators may control RMS via sequestration of circulating lymphocytes, thus raising questions about vaccination response in RMS on ozanimod and other S1P receptor modulators. Design/Methods: Prospective observational trial following patients with RMS who are going to be vaccinated against COVID-19. The primary endpoint is the proportion of subjects treated with ozanimod with SARS-CoV-2 anti-spike IgG positivity (Elecsys® Anti-SARS-CoV-2) 4 weeks after full vaccination as compared to pre-vaccination levels. To ensure a geographic distribution across the U.S., RMS patients were recruited online (under the care of various neurologists), and all study-related proceures were performed at the patient's home. Results: Descriptive statistics of antibody and T-cell response for sixty subjects (30 treated with ozanimod and 30 treated with various other FDA-approved RMS DMTs) assessed prior to and 28 days after full vaccination will be presented. Additionally, all subjects will complete follow-up questionnaires every 3 months until a year has passed from the second (or only) vaccine dose Conclusions: In this study, RMS patients treated with ozanimod had an antibody and T-cell response to the three available COVID-19 vaccines in the U.S. This trial is ongoing, with 48- weeks of follow-up expected in December 2022.