Humoral immune response to COVID-19 mRNA vaccine in patients with multiple sclerosis treated with high-efficacy disease-modifying therapies

• Published in: Therapeutic advances in neurological disorders Vol. 14; p. 17562864211012835
• Main Authors: Achiron, Anat, Mandel, Mathilda, Dreyer-Alster, Sapir, Harari, Gil, Magalashvili, David, Sonis, Polina, Dolev, Mark, Menascu, Shay, Flechter, Shlomo, Falb, Rina, Gurevich, Michael
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.01.2021; SAGE PUBLICATIONS, INC; SAGE Publishing
• Subjects: Cell number; Cladribine; Coronaviruses; COVID-19 vaccines; Dosage; Humoral immunity; Immune response; Immune response (humoral); Immunoglobulin G; Lymphocytes; Monoclonal antibodies; mRNA; Multiple sclerosis; Original Research; Patients; Serology; Severe acute respiratory syndrome coronavirus 2; Spike protein; Vaccination; Vaccines; COVID-19; SARS-COV-2 IgG; humoral immune response; multiple sclerosis; mRNA vaccine
• ISSN: 1756-2864; 1756-2856; 1756-2864
• DOI: 10.1177/17562864211012835

Background and Aims: The National Multiple Sclerosis Society and other expert organizations recommended that all patients with multiple sclerosis (MS) should be vaccinated against COVID-19. However, the effect of disease-modifying therapies (DMTs) on the efficacy to mount an appropriate immune response is unknown. We aimed to characterize humoral immunity in mRNA-COVID-19 MS vaccinees treated with high-efficacy DMTs. Methods: We measured SARS-CoV-2 IgG response using anti-spike protein-based serology (EUROIMMUN) in 125 MS patients vaccinated with BNT162b2-COVID-19 vaccine 1 month after the second dose. Patients were either untreated or under treatment with fingolimod, cladribine, or ocrelizumab. A group of healthy subjects similarly vaccinated served as control. The percent of subjects that developed protective antibodies, the titer, and the time from the last dosing were evaluated. Results: Protective humoral immunity of 97.9%, 100%, 100%, 22.7%, and 3.8%, was observed in COVID-19 vaccinated healthy subjects (N = 47), untreated MS patients (N = 32), and MS patients treated with cladribine (N = 23), ocrelizumab (N = 44), and fingolimod (N = 26), respectively. SARS-CoV-2 IgG antibody titer was high in healthy subjects, untreated MS patients, and MS patients under cladribine treatment, within 29.5–55 days after the second vaccine dose. Only 22.7% of patients treated with ocrelizumab developed humoral IgG response irrespective to normal absolute lymphocyte count. Most fingolimod-treated MS patients had very low lymphocyte count and failed to develop SARS-COV-2 antibodies. Age, disease duration, and time from the last dosing did not affect humoral response to COVID-19 vaccination. Conclusions: Cladribine treatment does not impair humoral response to COVID-19 vaccination. We recommend postponing ocrelizumab treatment in MS patients willing to be vaccinated as a protective humoral response can be expected only in some. We do not recommend vaccinating MS patients treated with fingolimod as a protective humoral response is not expected.