Abstract
BackgroundIn patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) affects immune response to antigens. Therefore, post-vaccination serological assessments are needed to evaluate the effect of the vaccine on SARS-CoV-2 antibody response.MethodsWe designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination with mRNA vaccines (BNT162b2, Pfizer/BioNTech,Inc or mRNA-1273, Moderna Tx,Inc). A blood collection before the first vaccine dose and 4 weeks after the second dose was planned, with a centralized serological assessment (electrochemiluminescence immunoassay, ECLIA, Roche-Diagnostics). The log-transform of the antibody levels was analyzed by multivariable linear regression.Findings780 pwMS (76% BNT162b2 and 24% mRNA-1273) had pre- and 4-week post-vaccination blood assessments. 87 (11·2%) were untreated, 154 (19·7%) on ocrelizumab, 25 (3·2%) on rituximab, 85 (10·9%) on fingolimod, 25 (3·2%) on cladribine and 404 (51·7%) on other DMTs. 677 patients (86·8%) had detectable post-vaccination SARS-CoV-2 antibodies. At multivariable analysis, the antibody levels of patients on ocrelizumab (201-fold decrease (95%CI=128–317), p < 0·001), fingolimod (26-fold decrease (95%CI=16–42), p < 0·001) and rituximab (20-fold decrease (95%CI=10–43), p < 0·001) were significantly reduced as compared to untreated patients. Vaccination with mRNA-1273 resulted in a systematically 3·25-fold higher antibody level (95%CI=2·46–4·27) than with the BNT162b2 vaccine (p < 0·001). The antibody levels on anti-CD20 therapies correlated to the time since last infusion, and rituximab had longer intervals (mean=386 days) than ocrelizumab patients (mean=129 days).InterpretationIn pwMS, anti-CD20 treatment and fingolimod led to a reduced humoral response to mRNA-based SARS-CoV-2 vaccines. As mRNA-1273 elicits 3·25-higher antibody levels than BNT162b2, this vaccine may be preferentially considered for patients under anti-CD20 treatment or fingolimod. Combining our data with those on the cellular immune response to vaccines, and including clinical follow-up, will contribute to better define the most appropriate SARS-CoV-2 vaccine strategies in the context of DMTs and MS.FundingFISM[2021/Special-Multi/001]; Italian Ministry of Health‘Progetto Z844A 5 × 1000′.
Highlights
The National Multiple Sclerosis Society and other expert organizations recommended that all patients with multiple sclerosis should be vaccinated against SARS-CoV-2
This study reports on the humoral response to Sars-Cov-2 mRNA vaccines of a large sample of patients with MS treated with all the disease-modifying therapies (DMTs)
In a second paper [2], the authors reported about SARS-CoV-2 IgG response one month after the second dose using anti-spike proteinbased serology in 125 MS patients under different DMTs vaccinated with BNT162b2 Covid-19 vaccine
Summary
The National Multiple Sclerosis Society and other expert organizations recommended that all patients with multiple sclerosis (pwMS) should be vaccinated against SARS-CoV-2 The impact of such vaccination, mainly in terms of serological responses, adverse effects, and clinical effectiveness, on pwMS treated with disease-modifying therapies (DMTs) is largely unknown. In a second paper [2], the authors reported about SARS-CoV-2 IgG response one month after the second dose using anti-spike proteinbased serology in 125 MS patients under different DMTs vaccinated with BNT162b2 Covid-19 vaccine. They observed that only 22¢7% of patients treated with ocrelizumab developed IgG response irrespective of normal absolute lymphocyte count, that most fingolimodtreated MS patients failed to develop SARS-COV-2 antibodies and that cladribine treatment had little impact on humoral response to Covid-19 vaccine.
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