目的:SARS-CoV-2疫苗对自身免疫性神经肌肉疾病患者的安全性存在担忧。我们使用SARS-CoV-2疫苗接种前后的疾病特异性患者报告结果指标(PROMs)比较了日常功能。
方法:在这项前瞻性观察性队列研究(Target-to-B!)的子研究中,重症肌无力(MG)患者,慢性炎性脱髓鞘性多发性神经病(CIDP),多灶性运动神经病(MMN),包括针对SARS-CoV-2接种疫苗的特发性炎性肌病(IIM)。日常功能调查(重症肌无力日常生活活动,炎性Rasch构建的整体残疾量表,多灶性运动神经病Rasch构建的总体残疾量表,和健康评估问卷-残疾指数)在首次疫苗接种前发送,此后每60天发送一次,为期12个月。构建回归模型以评估与疫苗接种相关的PROM评分的差异,与疫苗接种无关的分数进行比较。我们还评估了在第一次接种之前和之后60天之间至少具有最小临床重要差异(MCID)的恶化的患者的比例。
结果:我们纳入了325名患者(中位年龄=59岁,四分位数间距=47-67,156[48%]女性),其中137人(42%)患有MG,79(24%)hadCIDP,43(13%)有MMN,66人(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。在成对的PROM中,在49例(6%)MG患者中有3例观察到MCID恶化,其中没有人报告治疗改变。InCIDP,在29例患者中有8例(28%)观察到MCID恶化,其中8人中有2人(25%)报告治疗改变。
结论: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,确认这些患者的安全性。
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: SARS-CoV-2 vaccination had no effect on daily functioning in patients with autoimmune neuromuscular diseases, confirming its safety in these patients.