Results on SARS-CoV-2 mRNA Vaccine Booster from an Open-Label Multicenter Study in Ofatumumab-Treated Participants with Relapsing Multiple Sclerosis

Abstract

Background: Few data exist on how ofatumumab treatment impacts SARS-CoV-2 booster vaccination response. Methods: KYRIOS is an ongoing prospective open-label multicenter study on the response to initial and booster SARS-CoV-2 mRNA vaccination before or during ofatumumab treatment in relapsing MS patients. The results on the initial vaccination cohort have been published previously. Here, we describe 23 patients who received their initial vaccination outside of the study but booster vaccination during the study. Additionally, we report the booster results of two patients in the initial vaccination cohort. The primary endpoint was SARS-CoV-2-specific T-cell response at month 1. Furthermore, serum total and neutralizing antibodies were measured. Results: The primary endpoint was reached by 87.5% of patients with booster before (booster cohort 1, N = 8) and 46.7% of patients with booster during ofatumumab treatment (booster cohort 2, N = 15). Seroconversion rates for neutralizing antibodies increased from 87.5% at baseline to 100.0% at month 1 in booster cohort 1 and from 71.4% to 93.3% in booster cohort 2. Of note, 3 of 4 initially seronegative patients in booster cohort 2 and one seronegative patient in the initial vaccination cohort seroconverted after the booster during ofatumumab treatment. Conclusions: Booster vaccinations increase neutralizing antibody titers in ofatumumab-treated patients. A booster is recommended in ofatumumab-treated patients.

Neutralizing antibody titers over 12 months after SARS-CoV-2 mRNA vaccine booster in patients with relapsing multiple sclerosis continuously treated with ofatumumab

“…Neutralizing antibody titers observed under continued ofatumumab in the present analysis on average were as high as previously reported for patients receiving their booster before ofatumumab 3 or during treatment with other DMT. 9 Compared to healthy individuals, 8 neutralizing antibody titers reached after booster vaccination under continued ofatumumab treatment seem slightly lower.…”

“…Details on the design of the KYRIOS study and patient characteristics have been published previously. 3 , 4 Here, we report neutralizing antibody status over 1 year in patients who received only their booster vaccination in the KYRIOS study under continued ofatumumab treatment. These patients are a subgroup of cohort 2 and had been initially vaccinated outside of the KYRIOS study either during treatment with other DMT than ofatumumab or without receiving DMT.…”

“…Further booster vaccinations were optional. Assessment of immune responses was planned at month 0 (before first booster), month 1 (results have already been published 3 ), month 6, and month 12 after first booster. Optional assessments could be performed 1 month after second (optional) booster vaccination.…”

“…Ofatumumab treatment interruption is not necessary for the purpose of SARS-CoV-2 mRNA vaccination. 3 , 4 …”

“…Results on the immune responses 1 month after initial vaccination and 1 month after booster vaccination during continued ofatumumab treatment have already been published. 3 , 4 New data are now available from the KYRIOS study on the maintenance of the immune response over 12 months after booster vaccination.…”