Abstract
Background: The majority of multiple sclerosis [MS] patients treated with fingolimod fail to develop a protective level of IgG humoral and adaptive cellular immune responses following full BNT162b2 SARS-CoV-2 vaccination. Objective: To compare the efficacy of the third COVID-19 vaccine dose in vaccine non-responders fingolimod-treated MS patients. Study design: This is a prospective 3-month, single-center, randomized clinical trial. Methods: Twenty relapsing MS patients who had been on fingolimod therapy ≥ 12 months and failed to develop humoral IgG immune response to 2-dose Pfizer BNT162b2 COVID-19 vaccination were randomized into two groups: fingolimod-continuation group and fingolimod-discontinuation group. Humoral and memory cellular immune responses were assessed within 1 and 3 months following the third Pfizer BNT162b2 vaccine dose and compared between the groups. Results: A higher rate of patients in the fingolimod-discontinuation group [n = 8/10] compared to fingolimod-continuation group [n = 2/10] developed positive SARS-COV-2 IgG. Median IgG titer 1 month following the third dose was 202.3 BAU/ml vs. 26.4 BAU/ml, respectively, p = 0.022. The development of IgG humoral response correlated with absolute lymphocyte count. Specific SARS-COV-2 memory B cell and T cell immune responses were not detected in both groups, either at 1 month or 3 months following the third COVID-19 vaccine dose. Conclusions: Short period of fingolimod treatment discontinuation was associated with the development of humoral protection but not with adaptive cellular immunity.
Original language | English |
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Pages (from-to) | 2286-2292 |
Number of pages | 7 |
Journal | Journal of Neurology |
Volume | 269 |
Issue number | 5 |
DOIs | |
State | Published - May 2022 |
Externally published | Yes |
Bibliographical note
Publisher Copyright:© 2022, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany.
Keywords
- COVID-19
- Cellular immunity
- Fingolimod
- Humoral immunity
- IgG antibody
- Multiple sclerosis
- Third BNT162b2 SARS-CoV-2 vaccine dose
ASJC Scopus subject areas
- Neurology
- Clinical Neurology