Risk of relapse after COVID-19 vaccination among patients with multiple sclerosis in France: a self-controlled case series
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, MS patients have had priority access to COVID-19 vaccination. However, relapses following 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 one, two, and three (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. MS patients 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 one, two, or three (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 one 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], p=0.30. The same absence of risk was confirmed in various subgroups (age <50 years, duration of MS <10 years, use of DMT). A small increase in the relapse risk cannot be excluded after a booster dose (IRR =1.39 [1.08-1.80]) for patients with high MS activity, especially when not treated.
There is no increased risk of relapse requiring corticosteroid therapy after COVID-19 vaccination for almost all patients. We cannot exclude an increased risk following the booster dose for patients who have had at least two relapses in the previous two years.
This study provides Class III evidence that COVID-19 vaccination does not increase the risk of severe relapse in patients with multiple sclerosis.
Domaines
Neurosciences [q-bio.NC]Origine | Fichiers produits par l'(les) auteur(s) |
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