ABSTRACT
Background: Vaccination reduces the likelihood of a severe COVID-19 disease course. Therefore, vaccination against COVID-19 is generally recommended, even for people with autoimmune diseases such as multiple sclerosis (MS). Nevertheless, some people with MS (PwMS) have concerns about the vaccinations due to fear of disease worsening after the vaccinations. Objective(s): We aimed to analyse relapse activity and disability progression of PwMS stratified by COVID-19 vaccination scheme (homologous [HOM] vs. heterologous [HET]). Method(s): This study is based on a longitudinal observational study regarding the safety and tolerability of COVID-19 vaccines in PwMS. Acquisition of socio-demographic, clinical and vaccination data was conducted via several pseudonymised online surveys. PwMS with a minimum age of 18 years, a diagnosis of MS and a basic immunisation (usually two vaccinations) as well as >=1 booster vaccination against COVID-19 were included (N=2062). Patients with HOM (same vaccines) and HET vaccination schemes (different vaccines) were compared regarding relapse activity following vaccination and disability status (patient-determined disease steps [PDDS]). Result(s): The 2062 PwMS analysed showed a mean age of 47.1+/-11.0 years and a female proportion of 78.5%. The most common MS course was relapsing-remitting MS (74.8%). Most PwMS were currently treated with a disease-modifying drug (73.9%). Relapses after any COVID-19 vaccination occurred in 5.8% of PwMS. Comparing the disability level following the first vaccination with the period after the booster vaccination, a PDDS decrease was reported by 16.4% of PwMS, an increase by 13.6% and no change by 70.0%. The majority of patients reported a HOM vaccination scheme (59.4%), while 40.6% received HET vaccination (28.0%: different mRNA vaccines [HET1], 12.6%: mRNA + vector vaccines [HET2]). The only significant difference (p=0.012) between patients stratified by vaccination scheme was related to the mean age: PwMS receiving HOM vaccination (46.5+/-11.2 years) were younger than patients with HET vaccination (HET1: 48.4 years, HET2: 48.1 years). These patient subgroups revealed no considerable difference regarding the frequency of relapses following vaccination (HOM: 4.7%, HET1: 5.2%, HET2: 6.9%;p=0.3). Conclusion(s): The frequency of relapses and disability progression following COVID vaccinations do not appear to be associated with the type of vaccination regimen administered.
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
Background: At the beginning of the SARS-CoV-2 pandemic, the German MS-Registry and the German Multiple Sclerosis Society, started a survey to examine the impact on the behavioral changes of people with MS (PwMS) and the count of SARSCoV- 2 infections, following recommendations of the global data sharing initiative. In prospect of a vaccine against SARS-CoV-2 in Nov-2020, the survey was redesigned to address the participant's attitude towards a SARS-CoV-2-vaccination. Objective: We aim to provide new insights into the vaccination attitude of PwMS. Results: By January 31, 2021, 914 PwMS (77% female) participated in the survey. The average age was 48 (±11.8) years. 72% suffered from relapsing (RR) and 28% from progressive (PP/SP) MS. 71% were on DMT at the time of the survey. 56% of the PwMS wanted to be vaccinated against SARS-CoV-2, 32% considered to be vaccinated, and 12% did not want to be vaccinated. Female PwMS (N=704): 53% wanted to be vaccinated, 34% considered to be vaccinated and 13% (N=94) did not want to be vaccinated. Male PwMS (N=210): 64% wanted to be vaccinated, 28% considered to be vaccinated and 9% did not want to be vaccinated. The highest willingness to be vaccinated was in the age group >65 years old (N=62) with 63%. In the age groups 35-44 years (N=227), 45-54 years (N=252) and 55-64 years (N=232), the willingness proportion in PwMS was over 55%. Under the age of 35 (N=141), the willingness proportion in PwMS was 46%. Objections against a vaccination: 72% feared possible side and long-term effects, 11% doubted the vaccination's efficacy and 18% had other concerns. These 'other' concerns included questions towards compatibility of vaccination with current treatment, the own immune response or the risk of a vaccination induced relapse. Many PwMS mentioned that they still have some questions about the vaccine's mode of action. 73% of the female participants were concerned about side and long-term effects, 18% had other concerns, and 9% wondered whether a vaccination would be effective. On the other hand, 68% of male participants were concerned about side and long-term effects, 13% had other concerns and 19% wondered whether a vaccination is effective (χ2-test,p<0.001). Conclusion: At the time of the survey 88% [CI 85-90%] of PwMS were positive towards being vaccinated which is significantly higher compared to a Germany-wide survey of the general population from November 2021 in which vaccination readiness was 71% [CI 68-74%], p<0.001.