(1) Background: The present study aims to report the side effects of vaccination against coronavirus disease 2019 (COVID-19) among patients with multiple sclerosis (MS) who were being treated with disease-modifying therapies (DMTs) in Poland. (2) Methods: The study included 2261 patients with MS who were being treated with DMTs, and who were vaccinated against COVID-19 in 16 Polish MS centers. The data collected were demographic information, specific MS characteristics, current DMTs, type of vaccine, side effects after vaccination, time of side-effect symptom onset and resolution, applied treatment, relapse occurrence, and incidence of COVID-19 after vaccination. The results were presented using maximum likelihood estimates of the odds ratio, t-test, Pearson’s chi-squared test, Fisher’s exact p, and logistic regression. The statistical analyses were performed using STATA 15 software. (3) Of the 2261 sampled patients, 1862 (82.4%) were vaccinated with nucleoside-modified messenger RNA (mRNA) vaccines. Mild symptoms after immunization, often after the first dose, were reported in 70.6% of individuals. Symptoms included arm pain (47.5% after the first dose and 38.7% after the second dose), fever/chills/flu-like symptoms (17.1% after the first dose and 20.5% after the second dose), and fatigue (10.3% after the first dose and 11.3% after the second dose). Only one individual presented with severe side effects (pro-thrombotic complications) after vaccination. None of the DMTs in the presented cohort were predisposed to the development of side effects. Nine patients (0.4%) had a SARS-CoV-2 infection confirmed despite vaccination. (4) Conclusions: Vaccination against SARS-CoV-2 is safe for people with MS who are being treated with DMTs. Most adverse events following vaccination are mild and the acute relapse incidence is low.
Background and ObjectivesSince vaccination against COVID-19 is available for over a year and the population of immunized individuals with autoimmune disorders is higher than several months before, an evaluation of safety and registered adverse events can be made. We conducted a large study of side effects following the COVID-19 vaccine among patients with multiple (MS) sclerosis treated with disease-modifying therapies (DMTs) and analyzed factors predisposing for particular adverse events.MethodsWe gathered data of individuals with MS treated with DMTs from 19 Polish MS Centers, who reported at least one adverse event following COVID-19 vaccination. The information was obtained by neurologists using a questionnaire. The same questionnaire was used at all MS Centers. To assess the relevance of reported adverse events, we used Fisher's exact test, t-test, and U-Menn-Whutney test.ResultsA total of 1,668 patients with MS and reports of adverse events after COVID-19 vaccination were finally included in the study. Besides one case marked as “red flag”, all adverse events were classified as mild. Pain at the injection site was the most common adverse event, with a greater frequency after the first dose. Pain at the injection site was significantly more frequent after the first dose among individuals with a lower disability (EDSS ≤2). The reported adverse events following immunization did not differ over sex. According to age, pain at the injection site was more common among individuals between 30 and 40 years old, only after the first vaccination dose. None of the DMTs predisposed for particular side effects.ConclusionsAccording to our findings, vaccination against COVID-19 among patients with MS treated with DMTs is safe. Our study can contribute to reducing hesitancy toward vaccination among patients with MS.
Background: Diagnosis of multiple sclerosis (MS) is established on criteria according to clinical and radiological manifestation. Cerebrospinal fluid (CSF) analysis is an important part of differential diagnosis of MS and other inflammatory processes in the central nervous system (CNS). Methods: In total, 242 CSF samples were collected from patients undergoing differential MS diagnosis because of the presence of T2-hyperintensive lesions on brain MRI. The non-MS patients were subdivided into systemic inflammatory diseases with CNS involvement (SID) or cerebrovascular diseases (CVD) or other non-inflammatory diseases (NID). All samples were analyzed for the presence of oligoclonal bands and ELISA was performed for detection of: INF gamma, IL-6, neurofilaments light chain (NF-L), GFAP, CHI3L1, CXCL13, and osteopontin. Results: The level of IL-6 (p = 0.024), osteopontin (p = 0.0002), and NF-L (p = 0.002) was significantly different among groups. IL-6 (p = 0.0350) and NF-L (p = 0.0015) level was significantly higher in SID compared to NID patients. A significantly higher level of osteopontin (p = 0.00026) and NF-L (p = 0.002) in MS compared to NID population was noted. ROC analysis found weak diagnostic power for osteopontin and NFL-L. Conclusions: The classical and non-standard markers of inflammatory process and neurodegeneration do not allow for sufficient differentiation between MS and non-MS inflammatory CNS disorders. Weak diagnostic power observed for the osteopontin and NF-L needs to be further investigated.
Speech and voice disorders are among the least well-described clinical manifestations of Multiple Sclerosis (MS) although their estimated prevalence reaches 40-50%. The aim of the present study was adaptation and validation of the Speech Pathology-Specific Questionnaire for Persons with Multiple Sclerosis (SMS) into the Polish language to be used as part of the diagnostic procedure to quantify important speech-related changes and to improve individual tailoring of therapeutic activities. Material and Methods:The study included a total number of 178 participants. The study group consisted of 107 patients diagnosed with Multiple Sclerosis, mean age 42.8±11.6 years and the Control Group were 71 healthy sex and age matched normophonic subjects, mean age 44.2±12.5 years with no neurological symptoms. Translated version of SMS was administered to all participants of the study. Voice Handicap Index (VHI) questionnaire was used for comparison purposes. Test-retest reproducibility, internal consistency, floor and ceiling effects, discriminant validity and construct validity of the Polish SMS were investigated. Preliminary assessment of diagnostic value of SMS was conducted on the basis of the results recorded in duration-related quartiles of the Study Group. Results: High value of Intraclass Correlation Coefficient (ICC= 0 .930) obtained for the test-retest indicates a good level of reproducibility of the Polish SMS. High Cronbach's alpha (α=0.94) proves the test's good internal consistency. There were no floor and ceiling effects for the SMS test score in the Study Group and they were negligible in the Control Group. A significant difference in mean SMS total scores between patients and controls (14.22 points vs. 6.06 points) shows discriminant validity of SMS. Similar differences were observed for all the subscales of the test (in t test: p<0.001). A statistically significant correlation was found for the SMS score and its all subscales, as well as between all the subscales of the test proving good construct validity of the test. Similarly, statistically significant correlations were observed for the total score of SMS and VHI (r=.817, p <0.001) as well as between the particular subscales of SMS test and the subscales of VHI. There was a statistically significant difference in the mean total score of SMS in the distinguished quartiles of the Study Group with the highest values (20 points) recorded in the group of patients suffering from MS for over 15 years. Conclusion: The psychometric properties of the Polish version of Speech Pathology-Specific Questionnaire indicate that it is a valid patient-reported outcome measure suitable for the assessment of speech-language pathology aspects on the population of Multiple Sclerosis patients and can be used as an complementary diagnostic tool in clinical practice.
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