自身免疫性神经肌肉疾病患者接种SARS-CoV-2疫苗后的日常功能报告。

IF 4.5 2区 医学 Q1 CLINICAL NEUROLOGY
Koos P. J. van Dam, Luuk Wieske, Eileen W. Stalman, Laura Y. L. Kummer, Anneke J. van der Kooi, Joost Raaphorst, Diederik van de Beek, Jan J. G. M. Verschuuren, Annabel M. Ruiter, Esther Brusse, Pieter A. van Doorn, Adája E. Baars, W. Ludo van der Pol, H. Stephan Goedee, Anja ten Brinke, S. Marieke van Ham, Theo Rispens, Taco W. Kuijpers, Filip Eftimov, the T2B! Immunity Against SARS-CoV-2 Study Group
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引用次数: 0

摘要

背景和目的:自身免疫性神经肌肉疾病患者接种 SARS-CoV-2 疫苗的安全性令人担忧。我们在接种 SARS-CoV-2 疫苗前后使用疾病特异性患者报告结果指标(PROMs)比较了患者的日常功能:在这项前瞻性观察性队列研究(Target-to-B!)的子研究中,纳入了接种 SARS-CoV-2 疫苗的重症肌无力(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)和特发性炎症性肌病(IIM)患者。在首次接种疫苗之前和之后长达 12 个月的时间里,每隔 60 天进行一次日常功能调查(肌无力日常生活活动调查、炎症性 Rasch-Built 总体残疾量表、多灶性运动神经病 Rasch-Built 总体残疾量表和健康评估问卷-残疾指数)。我们建立了回归模型来评估与接种疫苗有关的 PROM 评分与与接种疫苗无关的评分之间的差异。我们还评估了首次接种疫苗前和接种疫苗后 60 天内病情恶化至少达到最小临床意义差异 (MCID) 的患者比例:我们共纳入了 325 名患者(中位年龄 = 59 岁,四分位数间距 = 47-67,女性 156 [48%]),其中 137 人(42%)患有 MG,79 人(24%)患有 CIDP,43 人(13%)患有 MMN,66 人(20%)患有 IIM。与疫苗接种有关的 PROM 评分与与疫苗接种无关的评分没有差异。在成对的 PROMs 中,49 位 MG 患者中有 3 位(6%)观察到病情恶化的 MCID,其中没有人报告改变了治疗方案。在CIDP患者中,29名患者中有8名(28%)观察到病情恶化的MCID,其中8名患者中有2名(25%)报告改变了治疗方案: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,证实了其对这些患者的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Patient-reported daily functioning after SARS-CoV-2 vaccinations in autoimmune neuromuscular diseases

Patient-reported daily functioning after SARS-CoV-2 vaccinations in autoimmune neuromuscular diseases

Background and purpose

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.

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来源期刊
European Journal of Neurology
European Journal of Neurology 医学-临床神经学
CiteScore
9.70
自引率
2.00%
发文量
418
审稿时长
1 months
期刊介绍: The European Journal of Neurology is the official journal of the European Academy of Neurology and covers all areas of clinical and basic research in neurology, including pre-clinical research of immediate translational value for new potential treatments. Emphasis is placed on major diseases of large clinical and socio-economic importance (dementia, stroke, epilepsy, headache, multiple sclerosis, movement disorders, and infectious diseases).
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