Risk of Relapse After COVID-19 Vaccination Among Patients With Multiple Sclerosis in France: A Self-Controlled Case Series.
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
10 Sep 2024
10 Sep 2024
Historique:
medline:
14
8
2024
pubmed:
14
8
2024
entrez:
14
8
2024
Statut:
ppublish
Résumé
People with multiple sclerosis (MS) have an increased risk of severe coronavirus infection due to their level of motor disability or exposure to certain immunosuppressive treatments. Thus, patients with MS have had priority access to coronavirus disease 2019 (COVID-19) vaccination. However, relapses after vaccination have been reported, leading some patients to not seek the recommended booster doses. The main objective was to estimate the risk of severe relapse after 1, 2, and 3 (booster) doses of COVID-19 vaccination in patients with MS. The secondary objectives were to assess the risk of relapse in clinically meaningful subgroups according to the type of vaccine, the characteristics of the patients, and the use of disease-modifying treatments (DMTs). We conducted a nationwide study using data from the French National Health Data System. Patients with MS were identified according to ICD codes, specific treatments, and reimbursement data up to March 31, 2022. Relapses requiring treatment with high-dose corticosteroids were identified. A self-controlled case series method was used to evaluate the risk of relapse associated with COVID-19 vaccines in the 45 days after vaccination. The associated risk was evaluated after 1, 2, or 3 (booster) doses and is expressed as overall incidence rate ratios (IRRs) and in subgroups of interest. Overall, 124,545 patients with MS were identified on January 1, 2021, and 82% received at least 1 dose of a COVID-19 vaccine (n = 102,524) until December 31, 2021, for a total of 259,880 doses. The combined IRR for MS relapse was 0.97 (0.91-1.03, There is no increased risk of relapse requiring corticosteroid therapy after COVID-19 vaccination for almost all patients. We cannot exclude an increased risk after the booster dose for patients who have had at least 2 relapses in the previous 2 years. This study provides Class III evidence that COVID-19 vaccination does not increase the risk of severe relapse in patients with MS.
Sections du résumé
BACKGROUND AND OBJECTIVES
OBJECTIVE
People with multiple sclerosis (MS) have an increased risk of severe coronavirus infection due to their level of motor disability or exposure to certain immunosuppressive treatments. Thus, patients with MS have had priority access to coronavirus disease 2019 (COVID-19) vaccination. However, relapses after vaccination have been reported, leading some patients to not seek the recommended booster doses. The main objective was to estimate the risk of severe relapse after 1, 2, and 3 (booster) doses of COVID-19 vaccination in patients with MS. The secondary objectives were to assess the risk of relapse in clinically meaningful subgroups according to the type of vaccine, the characteristics of the patients, and the use of disease-modifying treatments (DMTs).
METHODS
METHODS
We conducted a nationwide study using data from the French National Health Data System. Patients with MS were identified according to ICD codes, specific treatments, and reimbursement data up to March 31, 2022. Relapses requiring treatment with high-dose corticosteroids were identified. A self-controlled case series method was used to evaluate the risk of relapse associated with COVID-19 vaccines in the 45 days after vaccination. The associated risk was evaluated after 1, 2, or 3 (booster) doses and is expressed as overall incidence rate ratios (IRRs) and in subgroups of interest.
RESULTS
RESULTS
Overall, 124,545 patients with MS were identified on January 1, 2021, and 82% received at least 1 dose of a COVID-19 vaccine (n = 102,524) until December 31, 2021, for a total of 259,880 doses. The combined IRR for MS relapse was 0.97 (0.91-1.03,
DISCUSSION
CONCLUSIONS
There is no increased risk of relapse requiring corticosteroid therapy after COVID-19 vaccination for almost all patients. We cannot exclude an increased risk after the booster dose for patients who have had at least 2 relapses in the previous 2 years.
CLASSIFICATION OF EVIDENCE
METHODS
This study provides Class III evidence that COVID-19 vaccination does not increase the risk of severe relapse in patients with MS.
Identifiants
pubmed: 39141880
doi: 10.1212/WNL.0000000000209662
doi:
Substances chimiques
COVID-19 Vaccines
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM