Humoral immune response to COVID-19 mRNA vaccines in patients with relapsing multiple sclerosis treated with ofatumumab
- PMID: 37769429
- DOI: 10.1016/j.msard.2023.104967
Humoral immune response to COVID-19 mRNA vaccines in patients with relapsing multiple sclerosis treated with ofatumumab
Abstract
Background: There are limited data available regarding the impact of ofatumumab, an anti-CD20 B-cell-depleting monoclonal antibody for relapsing multiple sclerosis (RMS), on vaccination response. The study objective was to assess humoral immune response (HIR) to non-live coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccination in patients with RMS treated with ofatumumab.
Methods: This was an open-label, single-arm, multicenter, prospective pilot study of patients with RMS aged 18-55 years who received 2 or 3 doses of a COVID-19 mRNA vaccine after ≥1 month of subcutaneous ofatumumab (20 mg/month) treatment. The primary endpoint was the proportion of patients achieving HIR, as defined by local laboratory severe acute respiratory syndrome coronavirus-2 qualitative immunoglobulin G assays. Assay No. 1 was ≥14 days after the second or third vaccine dose. Assay No. 2 was 90 days thereafter.
Results: Of the 26 patients enrolled (median [range] age: 42 [27-54] years; median [range] ofatumumab treatment duration: 237 [50-364] days), HIR was achieved by 53.9% (14/26; 95% CI: 33.4 - 73.4%) at Assay No. 1 and 50.0% (13/26; 95% CI: 29.9 - 70.1%) at Assay No. 2. Patients who received 3 vaccine doses had higher HIR rates (Assay No. 1: 70.0% [7/10]; Assay No. 2: 77.8% [7/9]) than those who received 2 doses (Assay No. 1: 46.7% [7/15]; Assay No. 2: 42.9% [6/14]). Of patients aged <40 years without previous anti-CD20 therapy, HIR was achieved by 90.0% (9/10) at Assay No. 1 and 75.0% (6/8) at Assay No. 2. No serious adverse events were reported.
Conclusion: Patients with RMS treated with ofatumumab can mount HIRs following COVID-19 vaccination. A plain language summary, infographic and a short video summarizing the key results are provided in supplementary material.
Clinical trial registration: ClinicalTrials.gov: NCT04847596 (https://clinicaltrials.gov/ct2/show/NCT04847596).
Keywords: COVID-19; Humoral immune response; Ofatumumab; Relapsing multiple sclerosis; SARS-CoV-2.
Copyright © 2023. Published by Elsevier B.V.
Conflict of interest statement
Declaration of Competing Interest Amit Bar-Or has been a speaker in meetings sponsored by and received consulting fees and/or grant support from Atara Biotherapeutics, Biogen, Celgene/Receptos, Janssen/Actelion, Mapi Pharma, MedImmune, Merck/EMD Serono, Novartis, Roche/Genentech, and Sanofi Genzyme. Rany Aburashed has received consulting fees, research grants, and/or speaker honoraria from and served on scientific advisory boards for Bayer, Biogen, Genentech, Novartis, Sanofi, and Teva Pharmaceuticals. Angel R. Chinea has been a speaker for Allergan, Biogen, EMD Serono, Genentech, Novartis, Sanofi Genzyme, and Teva Pharmaceuticals. Barry A. Hendin has received advisory and speaking honoraria from Alexion Pharmaceuticals, Biogen, EMD Serono, Genentech, Genzyme, Horizon Therapeutics, Novartis, and TG Therapeutics. Elisabeth Lucassen and James Stankiewicz are employees of and stockholders in Novartis Pharmaceuticals Corporation. Xiangyi Meng was an employee of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, at the time of this analysis and during the development of this article. Mark J. Tullman has received consulting fees, research support, and/or speaking honoraria from Banner Life Sciences, Biogen, Bristol Myers Squibb, EMD Serono, Genentech, Genzyme, Horizon Therapeutics, Novartis, and TG Therapeutics. Anne H. Cross has received consulting fees and/or research support from Biogen, Bristol Myers Squibb, Celgene, Horizon Therapeutics, Janssen/Actelion, Jazz Pharmaceuticals, Merck/EMD Serono, Novartis, Roche/Genentech, and TG Therapeutics.
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