Department of Neurology and Neurophysiology, Amsterdam Neuroscience, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, the Netherlands.
Department of Clinical Neurophysiology, St. Antonius Hospital, Nieuwegein, the Netherlands.
Eur J Neurol. 2024 Dec;31(12):e16409. doi: 10.1111/ene.16409. Epub 2024 Sep 5.
There are concerns for safety regarding SARS-CoV-2 vaccines for patients with autoimmune neuromuscular disease. We compared daily functioning using disease-specific patient-reported outcome measures (PROMs) before and after SARS-CoV-2 vaccinations.
In this substudy of a prospective observational cohort study (Target-to-B!), patients with myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy (MMN), and idiopathic inflammatory myopathy (IIM) vaccinated against SARS-CoV-2 were included. Surveys of daily functioning (Myasthenia Gravis Activities of Daily Living, Inflammatory Rasch-Built Overall Disability Scale, Multifocal Motor Neuropathy Rasch-Built Overall Disability Scale, and Health Assessment Questionnaire-Disability Index) were sent before first vaccination and every 60 days thereafter for up to 12 months. Regression models were constructed to assess differences in PROM scores related to vaccination, compared to scores unrelated to vaccination. We also assessed the proportion of patients with deterioration of at least the minimal clinically important difference (MCID) between before first vaccination and 60 days thereafter.
We included 325 patients (median age = 59 years, interquartile range = 47-67, 156 [48%] female sex), of whom 137 (42%) had MG, 79 (24%) had CIDP, 43 (13%) had MMN, and 66 (20%) had IIM. PROM scores related to vaccination did not differ from scores unrelated to vaccination. In paired PROMs, MCID for deterioration was observed in three of 49 (6%) MG patients, of whom none reported a treatment change. In CIDP, MCID for deterioration was observed in eight of 29 patients (28%), of whom two of eight (25%) reported a treatment change.
SARS-CoV-2 vaccination had no effect on daily functioning in patients with autoimmune neuromuscular diseases, confirming its safety in these patients.
对于患有自身免疫性神经肌肉疾病的患者，人们对 SARS-CoV-2 疫苗的安全性存在担忧。我们比较了 SARS-CoV-2 疫苗接种前后使用疾病特异性患者报告结局测量（PROM）评估的日常功能。
在这项针对前瞻性观察队列研究（Target-to-B！）的子研究中，纳入了患有重症肌无力（MG）、慢性炎症性脱髓鞘性多发性神经病（CIDP）、多灶性运动神经病（MMN）和特发性炎性肌病（IIM）的患者，对他们进行了 SARS-CoV-2 疫苗接种。在首次接种疫苗前和此后每 60 天发送一次评估日常功能的调查问卷（MG 日常生活活动量表、炎症性 Rasch 构建整体残疾量表、多灶性运动神经病 Rasch 构建整体残疾量表和健康评估问卷残疾指数），持续 12 个月。构建回归模型以评估与疫苗接种相关的 PROM 评分与与疫苗接种无关的评分之间的差异。我们还评估了首次接种疫苗前和此后 60 天之间至少有最小临床重要差异（MCID）恶化的患者比例。
我们纳入了 325 名患者（中位年龄 59 岁，四分位间距 47-67，156 [48%]为女性），其中 137 名（42%）患有 MG，79 名（24%）患有 CIDP，43 名（13%）患有 MMN，66 名（20%）患有 IIM。与疫苗接种相关的 PROM 评分与与疫苗接种无关的评分没有差异。在配对的 PROM 中，MG 患者中有 3 名（6%）观察到 MCID 恶化，其中无一人报告治疗改变。在 CIDP 中，29 名患者中有 8 名（28%）观察到 MCID 恶化，其中 8 名中有 2 名（25%）报告了治疗改变。
SARS-CoV-2 疫苗接种对自身免疫性神经肌肉疾病患者的日常功能没有影响，证实了其在这些患者中的安全性。
