Fneish Firas, Frahm Niklas, Peters Melanie, Ellenberger David, Haas Judith, Löbermann Micha, Pöhlau Dieter, Röper Anna-Lena, Schilling Sarah, Stahmann Alexander, Temmes Herbert, Paul Friedemann, Zettl Uwe K
MS Forschungs- und Projektentwicklungs-gGmbH (MS Research and Project Development gGmbH [MSFP]), German MS Registry, 30171 Hannover, Germany.
Neuroimmunological Section, Department of Neurology, University Medical Center of Rostock, 18147 Rostock, Germany.
Vaccines (Basel). 2023 Dec 16;11(12):1859. doi: 10.3390/vaccines11121859.
Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify sociodemographic/clinical risk factors for PV relapses. PwMS were surveyed several times at baseline and four follow-ups as part of a longitudinal observational study regarding the safety and tolerability of the SARS-CoV-2 vaccination. The inclusion criteria for this analysis were age ≥18 years, ≥1 SARS-CoV-2 vaccination, and ≥1-year observation period since initial vaccination. Of 2466 PwMS, 13.8% reported PV relapses (mostly after second [N = 147] or booster vaccination [N = 145]) at a median of 8.0 (first/third quantile: 3.55/18.1) weeks PV, with the shortest period following initial vaccination (3.95 weeks). The ARR was 0.153 (95% confidence interval: 0.138-0.168), with a median observation period since initial vaccination of 1.2 years. Risk factors for PV relapses were younger age, female gender, moderate-severe disability levels, concurrent autoimmune diseases, relapsing-remitting MS courses, no DMT, and relapses within the year prior to the first vaccination. Patients' health conditions before/during initial vaccination may play a more important role in PV relapse occurrence than vaccination per se.
多项研究报告了接种新型冠状病毒2型疫苗（PV）后的症状。即使是多发性硬化症患者（PwMS）也担心接种新型冠状病毒2型疫苗后疾病活动情况。我们旨在确定接种疫苗后复发的PwMS比例、PV年化复发率（ARR）、从接种疫苗到随后复发的时间，并确定PV复发的社会人口统计学/临床风险因素。作为一项关于新型冠状病毒2型疫苗安全性和耐受性的纵向观察性研究的一部分，在基线和四次随访中对PwMS进行了多次调查。该分析的纳入标准为年龄≥18岁、≥1次新型冠状病毒2型疫苗接种以及自初次接种以来≥1年的观察期。在2466名PwMS中，13.8%报告在接种PV后出现复发（大多在第二次接种后[N = 147]或加强接种后[N = 145]），PV的中位时间为8.0周（第一/第三四分位数：3.55/18.1），初次接种后间隔时间最短（3.95周）。ARR为0.153（95%置信区间：0.138 - 0.168），自初次接种以来的中位观察期为1.2年。PV复发的风险因素包括年龄较小、女性、中度至重度残疾水平、并发自身免疫性疾病、复发缓解型MS病程、未使用疾病修正治疗（DMT）以及首次接种前一年内复发。初次接种前/期间患者的健康状况在PV复发发生中可能比接种本身发挥更重要的作用。
