Humoral Immune Response to SARS-CoV-2 Vaccination in MS Patients

Objective(s): The aim of this study was to study the humoral immune response to SARS-CoV-2 following vaccination in MS patients. Material(s) and Method(s): We performed a prospective study including all MS patients receiving one of the approved COVID-19 vaccines since January to September 2021. Demographic characteristics, MS treatments and adverse events reports after COVID-19 vaccination of vaccinated MS patients were collected. We analyzed the antibody response to SARS-CoV-2 vaccines with a chemiluminescent microparticle immunoassay (CMIA) from Abbot in MS patients with different DMTs at week 3, week 6 and month 3 after the first dose. The positivity cutoff is ≥50 AU/ml (manufacturer defined). 200 Healthy healthcare professionals were the control group. Result(s): We analyzed 165 vaccinated MS patients: 106 with Pfizer, 14 with Moderna, 42 with both doses of Astra zeneca and 3 with Jannsen. The mean age of patients was 45 (range: 21-71) and 46 for the controls. The most frequent adverse events were pain at injection site, headache and fatigue for 24-48 hours. No differences between MS patients and controls. No increased risk of relapse was noted in the first six months. 120 patients have received both doses of mRNA vaccine. Overall, mean antibody titers response to SARS-CoV-2 SARS-CoV-2 at three weeks was 7910,3 AU/mL (range 0-74947), at 6 weeks 16347,9 UA/mL (range:0-52380,5) and at 3 months 8182,10 UA/ml (range:0-33752,4) in mRNA vaccinated patients. By the mRNA vaccinated control group mean antibody titers response to SARS-CoV-2 SARS-CoV-2 at three weeks was 9397 AU/mL and at 6 weeks 18120 UA/mL Performing a subanalysis of the different DMTs: Only 3 out of 20 patients treated with ocrelizumab developed antibodies. Six vaccinated patients treated with rituximab had no antibody response. Four from 16 patients treated with fingolimod failed to develop a post-vaccination humoral response (< 50 AU/ml). 4 of 5 patients treated with ofatumumab developed have an adequate humoral response. Patients treated with interferon Beta, glatiramer acetate, teriflunomide, dimethyl fumarate, vaccinated with mRNA vaccines developed a similar post vaccination humoral response than healthy controls. Conclusion(s): Most of MS treated patients developed enough antibodies to SARS-CoV-2. The adverse events on MS patients were similar to the general population. No increase of relapse activity was observed. Some patients treated with ocrelizumab, rituximab and fingolimod have no developed a humoral response to SARS-CoV-2 vaccination. Hence we conclude that all approved COVID-19 vaccines are safe in MS patients and effective in most patients. However vaccine strategy in patients treated with anti-CD20 and fingolimod need further studies.

COVID-19 vaccination and humoral immune response in people with multiple sclerosis

Introduction: Due to the outbreak of the pandemic, the treatment and management of our patients is a challenge and more now with the Covid-19 vaccination. Objectives : To report our experience with Covid19 vaccines in MS patients and to study the antibody response to SARS-CoV-2 in MS patients. Methods: We performed a prospective study including all MS patients receiving one of approved vaccines since January 2021. Demographic characteristics, treatments and adverse events of vaccinated MS patients were collected. We analyze the developing antibodies to SARS-CoV-2 with an ELISA assay from Abbot in MS patients with different DMTs at week 3, week 6 and month 3 after the first dose. Healthy healthcare professionals were used as a control group. More than 50 UA/ml was considered an adequate immune humoral response. Results: We analyzed 96 vaccinated MS patients: 47 with Pfizer, 6 with Moderna, 42 with Astrazeneca and 1 with Jannsen. Mean age was 45 (range: 21-69). 52 patients have received both doses of mRNA vaccine. Patients have been vaccinated or by age (8,33%), disability (33%), or essential work (62,50%). The most frequent adverse events were paint at injection site, headache and fatigue. No increased risk of relapse was noted in the first three months. 52 patients have received both doses of mRNA vaccine. Patients vaccinated with AstraZeneca have received only the first dose due to public health issues. SARS-CoV-2 titer at three weeks was 7910,3 UA/mL (range 0-74947), at 6 weeks 16347,9 UA/mL (range:0- 52380,5) and at 3 months 8182,10 UA/ml (range:0-33752,4) in mRNA vaccinated patients. Only one from 5 patients treated with ocrelizumab developed antibodies (at 6 weeks 4783 UA/mL, at 3 months1087 UA/mL), the only vaccinated patient treated with rituximab has no antibody response. 3 from 6 patients treated with fingolimod failed to develop a post-vaccination humoral response, the other 3 had a low antibody response. Patients treated with interferon Beta, glatiramer acetate, teriflunomide, dimethyl fumarate, natalizumab and cladribine and vaccinated with mRNA vaccines develop a post vaccination humoral response ( range: 750-21257 UA/mL). Conclusions: Most of treated MS patients develop enough antibodies to SARS-CoV-2. Some patients treated with anti-CD20 and fingolimod failed to develop a post-vaccination humoral response. Adverse events were similar to the general population. No increase of relapse activity was observed.

Management of intravenous therapy for MS during COVID-19 pandemic

Introduction: MS patients have an increased risk of infections, especially patients with highly active treatments and therefore the Covid19 pandemic was a challenge for them. Objectives: We aim to study the safety and management of MS patients on intravenous therapy (IVT) during the COVID-19 pandemic. Methods: Prospective study of MS patients on IVT during COVID-19 pandemic (March 2020 to May 2021).Demographic features, timing of IVT and COVID-19 symptoms were collected. RT-PCR COVID-19 tests (PCR) from nasopharyngeal sample were performed before IVT in order to decrease risk of COVID19 spread at day hospital. Results: We analyzed 114 patients on IVT, 69% women with (mean age: 45years). We performed 950 RT-PCR COVID-19. 70 patients received antiCD20 treatment. All PCR before treatment infusion (117) were negative. 41 (30 ocrelizumab;11 rituximab) were RRMS patients (mean age: 43y) with a mean treatment duration of 30 months (range: 1-100). 4 patients on ocrelizumab suffered from COVID-19.Two of them required hospitalization with full recovery without mechanical ventilation. No patient on rituximab suffered from COVID-19. During first wave, IVT in patients with progressive MS and older age was delayed for few weeks. 29 patients with progressive forms (14 ocrelizumab, 15 rituximab) were treated with a mean treatment duration of 48 months (range 10-113). Only one progressive MS patient on ocrelizumab had Covid-19 disease and was hospitalized for 3 months without mechanical ventilation and full recovery. 71 patients were on natalizumab. 817 PCR were performed before natalizumab infusion. Sixteen patients showed a positive result and natalizumab was stopped;test was repeated 1-2 weeks later with a negative result and natalizumab was restarted. Overall, 21 patients had Covid-19, 11 were asymptomatic, 8 had mild symptoms, 2 pneumonia and only 1 of them was hospitalized without mechanical ventilation. 3 patients received alemtuzumab, all PCR were negative and there were only 1 patient with COVID-19 infection with mild symptoms and full recovery. Conclusions: Natalizumab and alemtuzumab treatments seem to be safe during Covid-19 pandemic. Patient on antiCD20 therapy seems to be at higher risk from most serious Covid-19 disease. PCR is a useful tool to prevent from virus shedding at day hospital.

Is natalizumab a safe treatment for patients with multiple sclerosis in the COVID-19 pandemic? Data from the first year of the pandemic

Background: Patients with MS have increased risk of infections, especially those with highly active treatments. We studied the safety of natalizumab in patients with MS during the COVID-19 pandemic. Methods: Demographic features, time on natalizumab, dose interval and COVID-19 symptoms were evaluated in a prospective study of patients with MS receiving natalizumab during the pandemic. RT-PCR COVID-19 tests from nasopharyngeal samples were performed before natalizumab treatment. Results: We analyzed 69 patients: 71% women, mean age 43 years. Mean treatment duration was 68 months (range: 2–141). In 32% of patients, natalizumab regimen was changed from every 4 to every 6 weeks to decrease number of hospital visits. From March to April 2020, 5 patients had COVID-19, 4 showed mild symptoms and 1 a multi-lobar pneumonia. On May 2020, we started COVID-19 screening before natalizumab infusion. From May 2020 to March 2021, tests were performed on 553 nasopharyngeal swabs. Fourteen patients had a positive result and natalizumab was stopped;tests were repeated 1–2 weeks later, with negative results, and natalizumab was restarted. In summary: 19 patients had COVID-19, 10 asymptomatic, 7 mild symptoms, 2 pneumonia (1 of whom hospitalized without mechanical ventilation). There were no statistically significant differences in age (mean±standard deviation, 35.7±11.5 vs 43.4±7.8 years;p=0.158), dose interval (5.33 vs 5.32 weeks;p=0.962) or treatment duration (5.8 vs 5.6 years;p=0.298) between patients with and without COVID-19. Conclusion: Natalizumab treatment in MS seems to be safe during the pandemic. Most patients were asymptomatic, and no patient required mechanical ventilation.

COVID-19 infection and vaccination in patients with multiple sclerosis during COVID pandemic

Background and aims: Patients with multiple sclerosis are treated with immunomodulatory and immunsuppresive treatments. Due to the outbreak of the pandemic, the management and treatment of our patients was a challenge, Objective : to study MS patients with Covid-19 and the first vaccinated patients. Methods: Prospective study. We analyzed the demographic characteristics, symptoms and treatment of Covid-19 infection and MS treatment. Results: 35 MS patients were infected with Covid-19 during the first wave . Average age was 40 years old with a disease duration of 10 years and an average EDSS of 2.5. 28 have a RRMS, three SPMS, two PPMS. 18 were confirmed by PCR ir serology and four by radiologic criteria. Only five patients were hospitalized and one of them died (EMSP, EDSS :8). 30 patients have a mild or very mild infection course. 31 patients were under MS treatment (48% highly active treatment). Three treatments were delayed 10 days and five treatments four weeks. The most frequent symptoms were fever, cough, dyspnea, fatigue. The infection duration were between one and seven weeks. 12 MS patients treated with DMTs received the first shot of mRNA vaccination without severe adverse events. Conclusion: MS patients have a similar evolution of Covid19 infection as healthy subjects. No MS treatment was related with worse outcome. Most of patients had continued the DMTs. It seems that the vaccination is safe for MS patients.

MS patients treated with natalizumab during the COVID-19 pandemic: Safety and management

Background and aims: MS patients treated with monoclonal antibodieshave an increased risk of infections, there are no enough data about COVID-19 infection. Natalizumab is a monoclonal antibody indicated in highly active Relapsing-Remitting MS. We aim to study the safety and management of MS patients on natalizumab during the COVID-19 pandemic. Methods: Prospective study of MS patients on natalizumab during COVID-19 pandemic considering risk of COVID-19 infection coming to day hospital for the infusion, disease risk and risk of delaying/stopping treatment. We evaluate demographic features, time on natalizumab and dose interval and COVID-19symptoms. RT-PCR COVID-19 tests from nasopharyngeal sample was performed before natalizumab treatment. Results: We analyzed 68 patients treated with natalizumab, 70% women and a mean age of 43 years, treated with natalizumab for 67 months (range: 2-139). In 33% of patients natalizumab treatment was changed from every four weeks to every six weeks to decrease visits to the hospital, 41% of patients continued receiving natalizumab every four weeks During first wave (March-June 2020), five patients suffered from COVID-19, four showed mild symptoms and one multilobar pneumonia solved with treatment. From May 2020 to January 2021, 451 nasal swab PCR COVID-test were carried out 24-72 hours before natalizumab infusion. 12 patients showed a positive result and natalizumab was stopped;test was repeated 1-2 weeks later with a negative result and natalizumab was restarted. Overall, 17 patients had COVID-19, nine asymptomatic and only one required hospitalization (tables 1-2). Conclusion: Natalizumab treatment seems to be safe in MS patient during COVID-19 pandemic. Most patients were asymptomatic. In some cases natalizumab was delayed but not discontinued. (Figure Presented).