Altieri Manuela, Melisi Rosario Domenico, Conte Miriana, Capuano Rocco, Donnarumma Giovanna, Grimaldi Elena, Coppola Nicola, De Pascalis Stefania, Risi Mario, d'Ambrosio Alessandro, Bisecco Alvino, Gallo Antonio
Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Experimental Medicine, Division of Pharmacology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Neurol Sci. 2023 Nov;44(11):4107-4110. doi: 10.1007/s10072-023-06975-7. Epub 2023 Jul 27.
Evusheld (EVS) was authorized by FDA and EMA as pre-exposure prophylaxis (PrEP) in people at high risk of severe Covid-19 outcomes, including people with Multiple Sclerosis (pwMS) on B-cell depleting (BCD) therapies-such as Ocrelizumab (OCR). In this population, no data on possible adverse drug reactions (ADRs) to EVS, B-lymphocytes (CD20 +) counts pre- and post-EVS injection, and comparison of percentage increase of IgG antibodies directed against SARS-CoV-2 trimeric spike protein (anti-TSP IgG) post-EVS and Covid-19 vaccine was available. The aim of this study was to better characterize the efficacy and safety profile of EVS in pwMS on BCD agents.
17 pwMS on OCR agreed to receive EVS as PrEP for Covid-19. Sera samples were collected before the first dose of Covid-19 vaccine (T0), 4 weeks after the second dose (T1), 4 weeks after third dose (T2), immediately before (T3) and 4 weeks after (T4) EVS.
Covid-19 vaccine ADRs were mild-to-moderate, whereas no ADRs were reported after EVS injection. A significant increase of anti-TSP IgG was found only at T0-T1 (Z = -3.059, p = .002) and T3-T4 (Z = -3.621, p < .001) time-points. The median percentage increase between T3-T4 was significantly higher with respect to the T0-T1(Z = -3.296, p = .001) and T1-T2 (Z = -3.059, p = .002) time-points.
These results further support EVS safety and efficacy in boosting anti-TSP IgG titers in pwMS on OCR, with a statistically greater increase than that observed after completion of a full Covid-19 vaccine cycle, plus a booster dose.
Evusheld（EVS）已获美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）批准，用于对严重新冠病毒病结局高风险人群进行暴露前预防（PrEP），包括接受B细胞耗竭（BCD）疗法（如奥瑞珠单抗（OCR））的多发性硬化症患者（pwMS）。在这一人群中，尚无关于EVS可能的药物不良反应（ADR）、EVS注射前后B淋巴细胞（CD20 +）计数，以及EVS后和新冠病毒病疫苗后针对严重急性呼吸综合征冠状病毒2三聚体刺突蛋白的IgG抗体（抗TSP IgG）百分比增加情况比较的数据。本研究的目的是更好地表征EVS在接受BCD药物治疗的pwMS中的疗效和安全性。
17名接受OCR治疗的pwMS同意接受EVS作为新冠病毒病的PrEP。在首次接种新冠病毒病疫苗前（T0）、第二剂后4周（T1）、第三剂后4周（T2）、EVS注射前即刻（T3）和EVS注射后4周（T4）采集血清样本。
新冠病毒病疫苗的ADR为轻至中度，而EVS注射后未报告ADR。仅在T0 - T1（Z = -3.059，p = 0.002）和T3 - T4（Z = -3.621，p < 0.001）时间点发现抗TSP IgG显著增加。T3 - T4之间的中位百分比增加相对于T0 - T1（Z = -3.296，p = 0.001）和T1 - T2（Z = -3.059，p = 0.002）时间点显著更高。
这些结果进一步支持EVS在提高接受OCR治疗的pwMS中抗TSP IgG滴度方面的安全性和有效性，其统计学上的增加幅度大于完成完整的新冠病毒病疫苗接种周期加一剂加强针后观察到的增加幅度。
