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Randomized Controlled Trial
. 2022 May;269(5):2286-2292.
doi: 10.1007/s00415-022-11030-0. Epub 2022 Mar 2.

Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod

Anat Achiron  1 , Mathilda Mandel  2 , Michael Gurevich  2 , Sapir Dreyer-Alster  2 , David Magalashvili  2 , Polina Sonis  2 , Mark Dolev  2 , Shay Menascu  2 , Gil Harari  2 , Shlomo Flechter  2 , Rina Falb  2
Affiliations
Randomized Controlled Trial

Immune response to the third COVID-19 vaccine dose is related to lymphocyte count in multiple sclerosis patients treated with fingolimod

Anat Achiron et al. J Neurol. 2022 May.

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.

Keywords: COVID-19; Cellular immunity; Fingolimod; Humoral immunity; IgG antibody; Multiple sclerosis; Third BNT162b2 SARS-CoV-2 vaccine dose.

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Conflict of interest statement

On behalf of all the authors, the corresponding author states that there is no conflict of interest.

Figures

Fig. 1
Fig. 1
Correlation analysis between SARS-COV-2 IgG levels and ALC in MS patients who continued and patients who stopped treatment with fingolimod at 1 and 3 months following the third Pfizer BNT162b2 COVID-19 vaccine dose, showing the significance of higher ALC with protective humoral immunity
See this image and copyright information in PMC

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