The professor of neurology at the NYU Grossman School of Medicine discussed the trial design of VIOLA, a new prospective study evaluating responses to COVID-19 vaccines in patients with MS on ocrelizumab (Ocrevus; Genentech). [WATCH TIME: 3 minutes]
WATCH TIME: 3 minutes
"If you measure B-cell levels and peripheral circulation, people who are treated with ocrelizumab usually don’t get any detectable levels of B-cells. The question is, how do those people who don’t have any peripheral B-cells develop responses to the vaccine. There is a little bit of literature with regard to vaccines other than COVID, because it has been concerned before.”
At the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 13-15, lead author Ilya Kister, MD, presented the study design and early results of VIOLA (NCT04843774), an open-label trial examining the longitudinal antibody and cellular responses of 2-dose mRNA-platform COVID-19 vaccines in ocrelizumab (Ocrevus; Genentech)-treated patients with multiple sclerosis (MS).
The 12-month study is expected to enroll 60 patients on the study drug, and investigators will collect T-cell and antibody responses to SARS-CoV-2 spike protein at pre-vaccination and at 4, 12, 24, and 48-weeks post-vaccination. It is designed to generate data that will help guide vaccine recommendations for patients with MS on anti-CD20 therapies. Ocrelizumab has been an FDA-approved therapy for adult patients with relapsing or primary progressive forms of MS since 2017. Notably, it was the first approved treatment for primary progressive MS.
Kister, professor of neurology, NYU Grossman School of Medicine, sat down with NeurologyLive to provide further details on the build of the study, as well as the reasons for why there was the urgent need to conduct it. He also touched upon the importance of collecting long-term data on vaccination responses.
For more coverage of ECTRIMS 2021, click here.