RESUMO
Despite protection from severe COVID-19 courses through vaccinations, some people with multiple sclerosis (PwMS) are vaccination-hesitant due to fear of post-vaccination side effects/increased disease activity. The aim was to reveal the frequency and predictors of post-SARS-CoV-2-vaccination relapses in PwMS. This prospective, observational study was conducted as a longitudinal Germany-wide online survey (baseline survey and two follow-ups). Inclusion criteria were age ≥18 years, MS diagnosis, and ≥1 SARS-CoV-2 vaccination. Patient-reported data included socio-demographics, MS-related data, and post-vaccination phenomena. Annualized relapse rates (ARRs) of the study cohort and reference cohorts from the German MS Registry were compared pre- and post-vaccination. Post-vaccination relapses were reported by 9.3% PwMS (247/2661). The study cohort's post-vaccination ARR was 0.189 (95% CI: 0.167-0.213). The ARR of a matched unvaccinated reference group from 2020 was 0.147 (0.129-0.167). Another reference cohort of vaccinated PwMS showed no indication of increased post-vaccination relapse activity (0.116; 0.088-0.151) compared to pre-vaccination (0.109; 0.084-0.138). Predictors of post-vaccination relapses (study cohort) were missing immunotherapy (OR = 2.09; 1.55-2.79; p < 0.001) and shorter time from the last pre-vaccination relapse to the first vaccination (OR = 0.87; 0.83-0.91; p < 0.001). Data on disease activity of the study cohort in the temporal context are expected for the third follow-up.
RESUMO
Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138-0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients' health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se.
RESUMO
Background: Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German and United Kingdom (UK) PwMS, especially regarding gender-specific differences. Methods: The German Multiple Sclerosis Society and the UK MS Registry acquired health data via an online system following the first (X1) and second SARS-CoV-2 vaccination (X2), respectively: sociodemographic and clinical data, vaccines used, VRs, MS deterioration (worsened or new MS symptoms, Germany only) and relapses (Germany only). The frequencies of VRs and MS deterioration were analysed stratified by gender. Findings: Following X1 (X2), 2346 (1835) German PwMS and 3796 (683) UK PwMS participated in the study. The most frequent vaccination scheme was two-dose tozinameran for Germany (77·1%, 1424/1847) and two-dose AZD1222 for the UK (61·3%, 419/683). The most common VRs were fatigue, headache and pain (at the injection site) and occurred more often in women compared with men. German PwMS reported VRs more frequently after X2 vs. X1 (65·4% [1201/1835] vs. 61·2% [1435/2346]), while for UK patients it was the opposite (X1 vs. X2: 48·7% [1849/3796] vs. 30·0% [205/683]). MS deterioration occurred in 19·0% (445/2346) of the German PwMS without resulting in gender-specific differences. Fatigue and gait impairment were the most frequent deteriorated MS symptoms. Interpretation: Female PwMS reported experiencing VRs more often than men. Longitudinal data are needed to enable valid statements regarding long-term MS deterioration and long-lasting VRs. Funding: German Multiple Sclerosis Society (DMSG Bundesverband e.V.), Biogen, Bristol Myers Squibb, Merck Serono, Mylan, Novartis, Roche and Sanofi.
RESUMO
BACKGROUND: Multiple sclerosis (MS) is the most common autoimmune inflammatory disease of the central nervous system in Europe, often causing severe physical, cognitive and emotional impairments. Currently, it is unclear whether the healthcare provisions of people with MS (PwMS) are in line with the recommendations for treatment based on guidelines or patients' needs. The main objectives of the study are as follows: (a) to investigate how well PwMS are treated; and (b) to develop a needs-oriented, patient-centred care model. METHODS: This mixed-methods study focuses on adult PwMS living in Lower Saxony, a federal state in Germany. The qualitative study comprises focus groups with PwMS, physicians and people involved in the healthcare process as well as a future workshop. The quantitative study comprises a cross-sectional online survey and addresses the patient-relevant outcomes and needs, as previously determined by literature searches and focus groups. It will be administered to all PwMS who are insured by the statutory health insurance company involved in the project (n~7,000). The survey data will be linked to the longitudinal secondary data from the statutory health insurance company and data from the German MS registry where available. The linked and single data sources will be statistically analysed. DISCUSSION: By comprehensively comparing the current healthcare provisions with the needs and requirements of PwMS, the strengths and weaknesses of the overall healthcare process and provision of assistive devices can be identified. The barriers and facilitators of the health service providers and their impact on daily life will be explored (qualitative analyses). Reliable recommendations for improvements will be given based on a study population drawn from the largest statutory health insurance company in Lower Saxony (quantitative analyses). However, the inherent advantages and limitations of the qualitative and quantitative research approaches need to be considered. TRIAL REGISTRATION: The study is registered at German Clinical Trials Register DRKS00021741.