Many multiple sclerosis (MS) patients remain hesitant to get vaccinated against COVID-19 for fear of relapse, especially those on disease-modifying treatments (DMTs), which could potentially affect response to the vaccine. With this in mind, the research team behind a new nationwide study sought answersand by extension a measure of comfort, perhapsfor patients who are concerned that this prophylactic measure may exacerbate their MS.1
For patients and physicians, the results are reassuring
This registry-based study of patients with MS, which was published in the European Journal of Neurology, assessed the risk of a clinically relevant relapse associated with the COVID-19 vaccine in a large cohort (n=8169) of Danish patients.1 Among the study population, which included patients with relapsing forms of MS, there was no notable change in the percentage of patients who relapsed in the 90days (1.3% versus 1.4% of patients; P=.627) and 180days (2.7% versus 2.6%; P=.918) both before and after receiving the COVID vaccine. (The observational period post-vaccination, notably, was also longer in this study than in prior ones.)
Similarly, in terms of annualized relapse rates (ARR), there was no statistically significant difference between the 3 periods studied:
Given these findings, the authors reported that their results overall can be relied upon to moderate vaccine hesitancy in patients with MS.
Physicians can glean considerable confidence from this extensive study, which includes more than 8000 patients, regarding the safety profile of vaccines in patients with multiple sclerosis, lead author Dominika Stastna, MD, PhD, a neurologist and neuroscientist at Charles University and General University Hospital in Prague, told MedPage Today.
Vaccine compliance rates are found to be high
The study draws some of its strength from its country of origin. Care of Danish patients with MS is centralized at 13 MS treatment centers across Denmark, where, for almost 30 years, it has been mandatory to document demographic and clinical information during regular visits. Danish patients with MS also showed a high rate of compliance with the national COVID vaccination program: Among the total study population, 87.3% agreed to receive the initial dose of the vaccine; of these patients, 99.7% completed the second dose, and more than 90% followed up with a third dose.
This also indirectly indicates trust in the health system and good tolerance, says Dr. Stastna.
Data were pulled from the Danish Multiple Sclerosis Registry, which Dr. Stastna praised. Our paper shows the importance of real-world data collection and the usefulness of patient registries, she explains. Indeed, in times of global pandemic, these have helped to confirm the safety of a key weapon against infectionvaccinationin specific populations that are generally not represented in clinical trials.
Considering the effects of DMTs
Patients with higher Expanded Disability Status Scale scores in this study faced an increased risk of relapse, as did younger patients (the latter finding consistent with those of prior studies). Considering that the authors only studied individuals with clinically isolated syndrome and relapsing-remitting MS, this heightened risk may stem from the fact that these patients have more-active disease in general.
In that vein, the strongest predictor of future relapse post-vaccination was the occurrence of a relapse in the year pre-vaccination. Given that DMTs are one of the most relevant factors affecting relapse, the authors performed subgroup analyses including only patients who did not initiate, switch, or discontinue DMTs during the observational period. Even in this population, however, there was no evidence of higher risk of relapse in connection with the COVID-19 vaccine.
Therefore, for patients with MS who worry that protecting themselves against COVID might mean exacerbating their disease activity, the results of this robust study are heartening.
This substantial body of evidence can be a valuable tool for physicians in reassuring patients who might be hesitant about vaccination, demonstrating a well-documented safety record in this specific population, concluded Dr. Stastna.
Published: February 28, 2024
Caitlan Rossi is a scientific and medical writer.
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