Clinical Significance of VIOLA Interim Results: Ilya Kister, MD


The professor of neurology at the NYU Grossman School of Medicine provided context on the preliminary data evaluating antibody response in ocrelizumab-treated patients post-vaccine. [WATCH TIME: 5 mintues]

WATCH TIME: 5 minutes

"We had hoped that the t-cell responses would be adequate in b-cell depleted patients, and in fact that’s what we saw. The t-cell responses were similar and comparable to healthy controls. They went up a little in the first 4 weeks and started going down after that.”

In addition to the study design, investigators presented interim data from VIOLA, an open-label study (NCT04843774), at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 13-15. The primary objective was to examine longitudinal antibody and cellular responses to 2-dose mRNA platform COVID-19 vaccines in ocrelizumab (Ocrevus; Genentech)–treated patients with multiple sclerosis (MS) over a 12-month period. They reported on data from 16 patients for whom prevaccination baseline, 4- and 12-week post vaccination timepoints were available.

At the 4-week period, immunoglobulin spike levels were significantly increased from baseline in both patients on ocrelizumab and health controls. Between the 4- and 12-week period, investigators observed significant decreases of these levels in all but 1 patient on study drug and in all healthy controls. Although the patient numbers were limited, the early data will help guide vaccine recommendations for patients with MS who are on anti-CD20 therapies.

Lead investigator Ilya Kister, MD, professor of neurology, NYU Grossman School of Medicine, sat down with NeurologyLive to discuss the results in full and see how they stack up in comparison to what has previously been observed with this patient population.

For more coverage of ECTRIMS 2021, click here.

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