New Data Highlight Immune Response to COVID-19 Vaccines in Individuals with Relapsing Forms of Multiple Sclerosis Treated with Zeposia (ozanimod)

Bristol Myers Squibb announced new data on COVID-19 vaccine responses in participants treated with Zeposia (ozanimod) from the ongoing Phase 3 DAYBREAK open-label extension (OLE) study in relapsing multiple sclerosis. For participants who showed no evidence of recent COVID-19 infection, results showed seroconversion occurred in 100% (80/80) and 62% (18/29) of fully vaccinated mRNA and non-mRNA vaccine recipients, respectively. These data are to be presented as late-breaking research (Presentation #OPR-162) on June 28, 2022 (8:45-9:00 CEST) at the European Academy of Neurology (EAN) Congress in Vienna, Austria.

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$BMY announces new data exploring immune response to COVID-19 vaccines in people with relapsing #multiplesclerosis treated with an approved medicine. #EAN2022

This research was conducted from January 2020 to October 2021, and higher antibody levels were observed at all tested timepoints from four weeks to >12 weeks in mRNA vaccine recipients who completed the two-dose regimen (grand mean 512.6 U/mL, range: 1.3-4572) versus those with one dose (grand mean 39.3 U/mL, range: 0.4-368.5) indicating that patients on Zeposia develop an adequate primary response and may receive a potential benefit from booster doses.

“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 non-RNA 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 of treatment-emergent COVID-19 events occurring from November 1, 2019 to May 10, 2021, results showed that the benefit:risk profile of Zeposia remains unchanged with most COVID-19 cases being non-serious, with the majority resolving without treatment interruption.

“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.”

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Bristol Myers Squibb-sponsored abstracts that will be presented at the EAN Congress 2022 are listed below. Complete abstracts can be accessed online here.

Zeposia Presentations

• Serologic response to SARS-CoV-2 vaccines in DAYBREAK participants with relapsing multiple sclerosis receiving ozanimod
  Author: Bruce Cree
  Presentation number: OPR-162
  Session: Late-breaking news 2
• Positive association between baseline brain volume and long-term cognition in patients with relapsing multiple sclerosis
  Author: John DeLuca
  ePoster number: EPO-127
  Session: MS and related disorders 1
• Analysis of multiple sclerosis relapse following discontinuation of ozanimod in DAYBREAK
  Author: Ralf Gold
  ePoster number: EPO-131
  Session: MS and related disorders 1
• Efficacy of ozanimod in disease-modifying treatment naive vs experienced patients with relapsing multiple sclerosis
  Author: Hans-Peter Hartung
  ePoster number: EPR-050
  Session: MS and related disorders 1
• Long-term outcomes with ozanimod in the DAYBREAK extension trial by number of multiple sclerosis relapses during the Phase 3 trials
  Author: Patrick Vermersch
  ePoster number: EPR-160
  Session: MS and related disorders 3

Bristol Myers Squibb thanks the patients and investigators who are participating in the Phase 3 DAYBREAK OLE clinical trial.

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