ABSTRACT
Introduction: In this study we aimed to monitor the risk of breakthrough COVID-19 infection in pwMS on different Disease Modifying Therapies (DMT) included in RELACOEM, a LATAM registry of MS and NMOSD patients infected with and vaccinated against COVID-19. Method(s): retrospective cohort study conducted between May 2021 and December 2021. The primary outcome was the appearance of infection during the follow-up time (at least three months after complete vaccination (second dose)). Specific information was requested (vaccine received, dose, date, symptoms, COVID- 19 infection, need for hospitalization, ventilatory assistance, treatment, and evolution). The primary objective of the analysis was to compare the incidence of breakthrough SARS-CoV-2 infections among the vaccinated pwMS in each DMT group. These conditions entail a PCR-confirmed test, and a time lag of at least 14 days from a full vaccination cycle (after the second vaccination dose). Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density. Result(s): A total of 857 pwMS patients from eight countries in LATAM were included. Mean age was 44.3 +/-12 years. The most frequent treatment used was fingolimod in 171 (19.9%). Most frequent first and second dose received was Astra-Zeneca (33%). During follow-up, a total of 28 COVID-19 cases were observed for a total exposure time of 150.965 days. The overall cumulative incidence was 3.2% (SE 0.22%) with an overall incidence density (ID) of 1.8 x 10.000 patients/day (95%CI 0.2-3.2). Compared to other DMTs, the incidence rate of breakthrough infections was significantly higher on ocrelizumab (6.02 (95%CI=5.65-7.16, RR=5.17 95%CI 3.27-7.12) and rituximab (6.94 (95%CI=6.15-9.12, RR= 5.93 95%CI 3.55-7.32) compared with other DMTs. No significant differences in the risk of breakthrough were observed for vaccine subtypes. Conclusion(s): An increased risk of breakthrough COVID-19 infections was observed in patients treated with ocrelizumab and rituximab.
ABSTRACT
Introduction: Most reports related to humoral immune response to COVID 19 vaccines in people with Multiple Sclerosis (pwMS) were performed on mRNA-based vaccines. Objective(s): to analyze the longitudinal humoral immune responses to adenovirus-based vaccines (Sputnik V and AZD1222) in pwMS under different diseases modifying therapies (DMTs) Methods: IgG anti- SARS-COV-2 spike titers in a cohort of 101 pwMS and 28 healthy controls (HC) were measured 6 weeks after vaccination using the COVID-AR kit according to the manufacture instructions. Both patients and controls received two or three doses of Sputnik, AZD1222 or a mixed schedule (MS) of both vaccines. The neutralizing capacity was evaluated by measuring antibody neutralizing titers using SARS COV-2 pseudotyped particles. Result(s): 60.5% of pwMS were female, mean EDSS: 2.49 +/-1.5, age: 36.6 +/-10.7, disease duration 7.6 +/- 5.1 years. DMTs: 45 pwMS were under fingolimod, 23 under dimethyl fumarate, 14 under cladribine and 19 under antiCD20 monoclonal antibodies. Vaccines: 35.7% Sputnik V, 51.9% AZD1222 and 12.4 % MS. No antibody response to a 2nd dose was found in 41.3% of pwMS under fingolimod and 73.6% under antiCD20. We found a correlation between lower lymphocyte count and lower antibody titers in pwMS under fingolimod (r: 0.67, 95% CI: 0.46-0.81, p=<=0.0001). A correlation was also found between the antibody titer and the last dose of antiCD20 (r: 0.49, 95% CI: 0.03-0.7, p=0.03). In March 2022, 57 pwMS received their 3nddose, 6 patients under fingolimod and 7 under antiCD20 remained without any antibody response. We did not find differences in the neutralization capacity with different DMT and or vaccines. Multivariate regression analysis showed antiCD20 (beta= -,349, 95% CI: -3655.6-369.01, p=0.017) and fingolimod (beta=-,399, 95% CI: -3363.8-250.9, p=0.023) treatments as independent factor associated with low antibody response (r2 adjusted=0.157). Conclusion(s): This is the first report of longitudinal humoral immune response of patients under adenovirus-based vaccines, specially Sputnik V, that demonstrate that these vaccines have similar results to those obtained with mRNA-based vaccines.
ABSTRACT
Objective: The objective of the study was to evaluate the incidence of COVID-19 infections after vaccination in NMOSD patients included in RELACOEM, a LATAM registry of MS and NMOSD patients infected and vaccinated for COVID-19. Method(s): Retrospective cohort study developed between May 2021 to December 2021. The primary outcome was the appearance of infection during the follow up time (at least three months after complete vaccination (second dose)). Data was collected through the contact between the treating physician and the patient. Specific information was requested (vaccine received, dose, date, symptoms, COVID-19 infection, need for hospitalization, ventilatory assistance, treatment, and evolution). The primary objective of the analysis was to compare the incidence of breakthrough SARS-CoV-2 19 infections among the vaccinated pwMS in each DMT group. These conditions entail a PCR-confirmed test, and a time lag of at least 14 days from a full vaccination cycle (after the second vaccination dose). Cumulative incidence was reported by Kaplan Meier survival curves as well as incidence density. Result(s): A total of 49 NMOSD patients from eight countries in LATAM were included. Mean age was 43.8 +/-13 years. The most frequent treatment use was rituximab in 29 (59.2%). The mean follow up after the second dose was 149 +/- 32 days. Most frequent first and second dose received was Pfizer (28.6%), followed by Sinopharm (24.5%). During follow up a total of 2 COVID-19 cases were observed for a total exposure time of 8627 days. Cumulative incidence was 4.1% (SE 0.87%) with an overall incidence density of 2.31 x 10.000 patients/day (95%CI 1.13-3.71). Both cases occurred in patients under rituximab (2/29, exposure time 4208, IR 4.7 x 10,000 patients/day 95%CI 3.5-5.1). No hospitalizations were reported for both cases. Conclusion(s): We observed an ID of COVID-19 infection after vaccination of 2.31 x 10.000 patients/day in NMOSD patients.