Dave Rahul H, Crayton Heidi, Miravalle Augusto, Tai Ming-Hui, Wyse Kerri, Houghton Katherine, Hitchens Abby, Berkovich Regina
Inova Medical Group-Neurology II, Fairfax, VA, USA.
Multiple Sclerosis Center of Greater Washington, Washington, VA, USA.
Neurol Ther. 2024 Dec;13(6):1737-1745. doi: 10.1007/s40120-024-00671-0. Epub 2024 Oct 23.
Real-world data are required to provide a greater understanding of the impact of ofatumumab on the ability to mount an effective immune response following the receipt of approved COVID-19 vaccinations. This retrospective real-world analysis aimed to describe the humoral immune response to COVID-19 vaccination during ofatumumab treatment in patients with multiple sclerosis (MS).
Data from patients with MS treated with ofatumumab who were fully vaccinated against COVID-19 infection were abstracted from medical charts at four clinical sites in the USA. Patient characteristics and humoral response were summarized descriptively. Differences in humoral response were documented on the basis of vaccination status during ofatumumab treatment (i.e., after full vaccination and after booster vaccination) and prior disease-modifying treatment (DMT) exposure (i.e., DMT naïve, prior anti-CD20/sphingosine 1-phosphate [S1P] therapy, prior non-anti-CD20/S1P therapy). The sample size precluded formal statistical analysis.
Thirty-eight patients were included. The mean (standard deviation) duration of ofatumumab treatment upon data collection was 20.4 (4.6) months (treatment ongoing for 35 [92%] patients). Definitive humoral response after full vaccination was documented for 34 patients, of whom 20 (60%) were seropositive. Definitive humoral response after booster vaccination was documented among five patients, of whom three (60%) were seropositive. Among patients who were DMT naïve prior to ofatumumab (n = 15), 73% were seropositive; among patients exposed to prior anti-CD20/S1P therapy (n = 14), 33% were seropositive; and among patients exposed to prior non-anti-CD20/S1P therapy (n = 9), 56% were seropositive. Patients naïve to DMT had been living with an MS diagnosis for a shorter duration than those experienced with DMTs.
Patients with MS receiving ongoing treatment with ofatumumab can mount a positive humoral response to a COVID-19 vaccination. Prior treatment with anti-CD20 or S1P DMTs may be a risk factor for lower humoral response.
需要真实世界的数据来更深入了解奥法木单抗对接种获批的新冠病毒疫苗后产生有效免疫反应能力的影响。这项回顾性真实世界分析旨在描述多发性硬化症（MS）患者在接受奥法木单抗治疗期间对新冠病毒疫苗的体液免疫反应。
从美国四个临床地点的病历中提取接受奥法木单抗治疗且已完全接种新冠病毒疫苗的MS患者的数据。对患者特征和体液反应进行描述性总结。根据奥法木单抗治疗期间的疫苗接种状态（即完全接种疫苗后和加强接种疫苗后）以及既往疾病修饰治疗（DMT）暴露情况（即未接受过DMT、既往接受过抗CD20/鞘氨醇1-磷酸[S1P]治疗、既往接受过非抗CD20/S1P治疗）记录体液反应的差异。样本量不足以进行正式的统计分析。
共纳入38例患者。数据收集时奥法木单抗治疗的平均（标准差）持续时间为20.4（4.6）个月（35例[92%]患者仍在接受治疗）。34例患者记录到完全接种疫苗后的明确体液反应，其中20例（60%）血清学阳性。5例患者记录到加强接种疫苗后的明确体液反应，其中3例（60%）血清学阳性。在奥法木单抗治疗前未接受过DMT的患者中（n = 15），73%血清学阳性；在既往接受过抗CD20/S1P治疗的患者中（n = 14），33%血清学阳性；在既往接受过非抗CD20/S1P治疗的患者中（n = 9），56%血清学阳性。未接受过DMT的患者MS诊断后的病程短于接受过DMT的患者。
正在接受奥法木单抗治疗的MS患者对新冠病毒疫苗可产生阳性体液反应。既往接受抗CD20或S1P DMT治疗可能是体液反应较低的危险因素。
