Pistor Maximilian, Hoepner Robert, Hoepner Andreas G F, Lin Yanan, Jung Simon, Bassetti Claudio L, Chan Andrew, Salmen Anke
Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse, 3010 Bern, Switzerland.
Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Ther Adv Neurol Disord. 2022 Oct 10;15:17562864221129383. doi: 10.1177/17562864221129383. eCollection 2022.
Evidence on mortality risks associated with MS-immunotherapies during the SARS-CoV2 pandemic derived thus far mainly from single country experiences.
In this analysis, we aim to determine the frequency of COVID-19 associated fatality reports of patients receiving an MS-immunotherapy as reported to the international Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from February 2020 to March 2021.
In all, 1071 cases for this cross-sectional analysis were retrieved from FAERS and a multivariable logistic regression was performed. We adjusted for sex, age, region, month of report to FDA, immunotherapy-class and additionally for healthcare-system and pandemic-related metrics.
Anti-CD20 therapies (60%) followed by sphingosine-1 phosphate modulators (12%) and dimethylfumarat (10%) were reported most frequently. In 50% of the cases, MS-phenotype is not reported, relapsing MS in 35% and progressive MS in 15%. Besides older age (odds ratio [OR]: 1.1; 95% confidence interval [CI]: 1.07-1.13; < 0.01), anti-CD20 therapies were significantly associated with a higher risk of death (OR: 4.1; 95% CI: 1.17-14.46; = 0.03), whereas female sex was associated with a reduced mortality risk (OR: 0.4, 95% CI: 0.22-0.72; < 0.01).
Using international open access data and a multidisciplinary approach for risk prediction, we identified an increased mortality risk associated with anti-CD20 therapies, which is in line with national and multi-national cohort studies.
迄今为止，关于严重急性呼吸综合征冠状病毒2（SARS-CoV2）大流行期间与多发性硬化症（MS）免疫疗法相关的死亡风险的证据主要来自单一国家的经验。
在本分析中，我们旨在确定2020年2月至2021年3月期间向国际食品药品监督管理局（FDA）不良事件报告系统（FAERS）报告的接受MS免疫疗法的患者中与2019冠状病毒病（COVID-19）相关的死亡报告频率。
总共从FAERS中检索了1071例用于该横断面分析的病例，并进行了多变量逻辑回归分析。我们对性别、年龄、地区、向FDA报告的月份、免疫疗法类别进行了校正，此外还对医疗保健系统和大流行相关指标进行了校正。
报告最频繁的是抗CD20疗法（60%），其次是1-磷酸鞘氨醇调节剂（12%）和富马酸二甲酯（10%）。在50%的病例中，未报告MS表型，复发型MS占35%，进展型MS占15%。除年龄较大外（比值比[OR]：1.1；95%置信区间[CI]：1.07-1.13；P<0.01），抗CD20疗法与较高的死亡风险显著相关（OR：4.1；95%CI：1.17-14.46；P=0.03），而女性与较低的死亡风险相关（OR：0.4，95%CI：0.22-0.72；P<0.01）。
使用国际开放获取数据和多学科方法进行风险预测，我们发现抗CD20疗法与死亡风险增加相关，这与国家和多国队列研究结果一致。
