Department of Advanced Medical and Surgical Sciences (DAMSS), University of Campania "Luigi Vanvitelli", Naples, Italy.
Department of Medical Sciences, Neurology Unit, AOU San Giovanni and Ruggi, Salerno, Italy.
J Neurol. 2022 Dec;269(12):6185-6192. doi: 10.1007/s00415-022-11296-4. Epub 2022 Jul 26.
The assessment of the safety and the humoral response to a third booster dose of the BNT162b2 mRNA COVID-19 vaccine is relevant in patients with Multiple Sclerosis (pwMS) treated with Ocrelizumab (OCR) or Fingolimod (FNG).
Serum samples were collected from Healthy controls (HCs) and pwMS treated with OCR or FNG at the following time-points: before the first of two vaccine doses (T0); 8 (T1), 16 (T2), 24 (T3) weeks after the first dose; within 8 weeks before (T0b) and after (T1b) the booster dose. IgG antibodies to SARS-CoV-2 trimeric spike protein (Anti-TSP IgG) were quantified and expressed as binding antibody units (BAU)/mL.
40 HCs, 28 pwMS on OCR and 19 on FNG were included. At T0b 12 (42.9%) pwMS on OCR and 6 (31.6%) on FNG were still positive while, at T1b 16 (57.14%) pwMS on OCR and 16 (84.2%) on FNG, passed the threshold of positivity. The increase of Anti-TSP IgG levels at T1b was higher for: (i) HCs with respect to OCR (p < 0.001) and FNG (p = 0.032) groups; (ii) pwMS on FNG compared with pwMS on OCR (p < 0.001). No socio-demographic, clinical or laboratory variables were able to predict the anti-TSP IgG increase between T0b and T1b. Neither clinical relapses nor severe adverse events were reported in pwMS after each dose of vaccine.
The third booster dose of BNT162b2 mRNA vaccine to OCR- and FNG-treated pwMS revives the humoral response, independently of any clinical variable, and manifests a good safety and tolerability profile.
在接受奥瑞珠单抗（OCR）或芬戈利莫德（FNG）治疗的多发性硬化症（pwMS）患者中，评估第三次 BNT162b2 mRNA COVID-19 疫苗加强针的安全性和体液反应至关重要。
在以下时间点采集健康对照者（HCs）和接受 OCR 或 FNG 治疗的 pwMS 的血清样本：两剂疫苗的第一剂之前（T0）；第一剂后 8（T1）、16（T2）和 24（T3）周；加强针之前（T0b）和之后（T1b）的 8 周内。使用 SARS-CoV-2 三聚体刺突蛋白（Anti-TSP IgG）定量 IgG 抗体，并以结合抗体单位（BAU）/mL 表示。
共纳入 40 名 HCs、28 名接受 OCR 治疗的 pwMS 和 19 名接受 FNG 治疗的 pwMS。在 T0b 时，12 名（42.9%）接受 OCR 治疗的 pwMS 和 6 名（31.6%）接受 FNG 治疗的 pwMS 仍为阳性，而在 T1b 时，16 名（57.14%）接受 OCR 治疗的 pwMS 和 16 名（84.2%）接受 FNG 治疗的 pwMS 通过了阳性阈值。与 OCR（p<0.001）和 FNG（p=0.032）组相比，T1b 时 Anti-TSP IgG 水平升高的情况在 HCs 中更高；（ii）与接受 OCR 治疗的 pwMS 相比，接受 FNG 治疗的 pwMS（p<0.001）。在 T0b 至 T1b 之间，没有任何社会人口统计学、临床或实验室变量能够预测 Anti-TSP IgG 的增加。在每次接种疫苗后，pwMS 均未报告临床复发或严重不良事件。
在接受 OCR 和 FNG 治疗的 pwMS 中，第三次 BNT162b2 mRNA 疫苗加强针可恢复体液反应，与任何临床变量无关，表现出良好的安全性和耐受性。
