From the Université Clermont Auvergne (X.M., C.C., P.C.), CHU Clermont-Ferrand, Inserm, Neuro-Dol; Univ Rennes (E.L.), EHESP, CNRS, Inserm, ARENES UMR 6051, RSMS U 1309; Service de Neurologie (F.T.), CHU Clermont-Ferrand; Service de Neurologie (S.V.), Sclérose en Plaques, Pathologies de la Myéline et Neuro-inflammation, Centre de Ressources, Recherche et Compétence sur la Sclérose en Plaques et Fondation Eugène Devic EDMUS pour la Sclé; and Biostatistics Unit (A.M.), DRCI, CHU Clermont-Ferrand, France.
Neurology. 2024 Sep 10;103(5):e209662. doi: 10.1212/WNL.0000000000209662. Epub 2024 Aug 14.
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, = 0.30). The same absence of risk was confirmed in various subgroups (age younger than 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 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.
由于运动障碍程度或接受某些免疫抑制治疗，多发性硬化症（MS）患者罹患严重冠状病毒感染的风险增加。因此，MS 患者优先接种了 2019 年冠状病毒病（COVID-19）疫苗。然而，据报道，接种疫苗后会出现复发，这导致一些患者不愿接受推荐的加强针剂量。主要目的是评估 COVID-19 疫苗接种后 1、2 和 3 剂（加强针）后 MS 患者发生严重复发的风险。次要目标是根据疫苗类型、患者特征和使用疾病修正治疗（DMT）评估具有临床意义的亚组中复发的风险。
我们使用法国国家健康数据系统的数据进行了一项全国性研究。根据 ICD 编码、特定治疗和报销数据，截至 2022 年 3 月 31 日，确定了 MS 患者。确定了需要用高剂量皮质类固醇治疗的复发。使用自我对照病例系列方法评估接种疫苗后 45 天内 COVID-19 疫苗相关复发的风险。接种后 1、2 或 3 剂（加强针）评估相关风险，并表示为总体发病率比值比（IRR）和感兴趣的亚组。
2021 年 1 月 1 日共确定了 124545 例 MS 患者，其中 82%至少接种了 1 剂 COVID-19 疫苗（n=102524），截至 2021 年 12 月 31 日，共接种了 259880 剂。MS 复发的合并 IRR 为 0.97（0.91-1.03，=0.30）。在各种亚组中（年龄小于 50 岁、MS 持续时间<10 年、使用 DMT）也证实了同样的无风险。对于 MS 活动度高的患者，尤其是未治疗的患者，在接种加强针后，复发风险可能会略有增加（IRR 1.39 [1.08-1.80]），但不能排除这种风险。
对于大多数患者来说，接种 COVID-19 疫苗后不会增加需要皮质类固醇治疗的复发风险。对于过去 2 年内至少有 2 次复发的患者，我们不能排除在加强针后复发风险增加的可能性。
本研究提供了 III 级证据，表明 COVID-19 疫苗接种不会增加 MS 患者严重复发的风险。
