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Sars-Cov-2 Vaccine Response in RMS Patients Treated with Ozanimod and Other Dmts
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. However, other studies have focused on the legacy, non-selective S1P receptor modulator, fingolimod; newer, selective for subtype 1 and 5, S1P receptor modulators may have improved humoral responses.
Objectives:
To describe antibody and T-cell responses to the SARS-CoV-2 mRNA vaccines in patients with relapsing multiple sclerosis (RMS) on ozanimod or other disease modifying therapies (DMTs).
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. T-cell response was measured by T-Detect. To ensure a geographic distribution across the U.S., RMS patients were recruited online (under the care of various neurologists), and all study-related procedures were performed at the patient’s home.
Results:
All ozanimod-treated patients (and all but the three patients treated with ocrelizumab and one with fingolimod). Among ozanimod-treated patients, the mean increase in IgG antibody titer 4-weeks after either of the two available mRNA vaccines was 232.73 AU/m, while the mean increase in the IgG titers for non-ozanimod-treated patients was 526.59 AU/mL. Only three of the patients studied were taking ocrelizumab, and in those patients, the mean increase in IgG titers was 0.633. Despite lower (but generally accepted as protective) antibody titers in the ozanimod-treated patients, all but one patients had a positive result on T-Detect.
Conclusions:
In this study, RMS patients treated with ozanimod had an antibody and T-cell response to the mRNA COVID-19 vaccines. This trial is ongoing, with 48-weeks of follow-up expected in December 2022.