ABSTRACT
Background: As the COVID-19 pandemic continues, evidencebased clinical guidance for managing the care of people with multiple sclerosis (MS) is an ongoing concern. In recent months, data from cohorts of people with MS has indicated that certain demographic and clinical characteristics, including use of some disease- modifying therapies (DMTs), leads to worse outcomes from SARS-CoV-2 infection. The COVID-19 in MS global data sharing initiative, which now includes over 4,500 confirmed COVID- 19 cases in people with MS, gives the opportunity to corroborate previous findings with greater certainty. Methods: Clinician-reported data from 32 countries were aggregated into a dataset of 5,543 patients who had suspected or confirmed COVID-19. Demographic and clinical covariates were queried, alongside COVID-19 clinical severity outcomes. These outcomes (hospitalisation, admission to ICU, requiring artificial ventilation, and death) were assessed in patients with suspected/ confirmed COVID-19 using multilevel mixed-effects logistic regression. All models were corrected for age, sex, EDSS, and MS type. DMTs were individually compared to glatiramer acetate (GA), as well as to pooled other DMTs and natalizumab. Results: Of 5,543 patients in the clinician-reported dataset, 909 with suspected and 4,634 with confirmed COVID-19 were included in the analysis. Previous demographic findings were confirmed: male sex, older age, progressive MS, and higher disability were associated with worse outcomes from SARS-CoV-2 infection. Use of anti-CD20 DMTs (ocrelizumab and rituximab) was associated with worse COVID-19 outcomes. Compared to GA, ocrelizumab and rituximab were associated with increased risk of hospitalisation (aOR=1.61(95%CI=1.06-2.43);aOR=2.42(95%CI=1.54-3.81) and ICU admission (aOR=3.13(95%CI=1.22-8.00);aOR=4.46 (95%CI=1.64-12.09)). Rituximab was associated with increased risk of artificial ventilation (aOR=3.57(95%CI=1.38-9.20));ocrelizumab showed a positive trend (aOR=1.86(95%CI=0.76-4.55). Rituximab showed a positive trend with increased risk of death (aOR=2.74(95%CI=0.68-11.09). Associations persisted on restriction to confirmed COVID-19 cases. Conclusions: Analysing the largest international real world dataset of people with MS who have suspected or confirmed COVID- 19 confirms previous findings that male sex, older age, progressive MS, higher disability, the use of anti-CD20 medication (ocrelizumab and rituximab) are associated with worse COVID-19 outcomes.
ABSTRACT
Introduction: Patients with MS (pwMS) are currently receiving different COVID-19 vaccines in several Latin American countries. However, questions arise around the safety of these vaccines and whether vaccination might increase the risk of relapse activity. Therefore, we aimed to assess the safety and occurrence of relapses following COVID-19 vaccination in Latin American pwMS. Methods: A web-based survey was completed by 207 pwMS from Latin America to assess for adverse events associated with COVID-19 vaccination between February 1 and April 30, 2021. Results: All participants received the first dose and 84 the second. The different vaccines administered were: inactivated virus vaccines [(IVV);CoronaVac, BBIBP-CorV) ] in 117 (56.5%) patients, adenovirus vector vaccines [(AdV);Gam-COVID-Vac, AZD1222] in 53 (25.6%) and mRNA vaccines (BNT162b2) in 37 (17.9%). The mean follow-up after vaccination was 24 ± 16 days. Three (1.4%) patients reported having COVID-19 infection after vaccination (all occurring after the first dose). Any adverse events were reported in 61 (29.5%) and 23 (27.4%) individuals after the first and second doses respectively. These included pain at the injection site, headache, fever, flu-like symptoms, fatigue, and muscle or joint pain. A lower frequency of adverse events was found with IVV (x?=7.2, p=0.03). Four (1.9%) patients reported an MS relapse, all occurring after an IVV first dose. Mean time to relapse: 18 ± 13 days. None of these patients had stopped or postponed their MS treatment before vaccination. Conclusion: COVID-19 vaccines seem to be safe for pwMS from Latin America. No major safety signals appeared in this patientreported study.