Low protection from breakthrough SARS-CoV-2 infection and mild disease course in ocrelizumab-treated patients with multiple sclerosis after three mRNA vaccine doses.

Low protection from breakthrough SARS-CoV-2 infection and mild disease course in ocrelizumab-treated patients with multiple sclerosis after three mRNA vaccine doses.
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DOI:
10.1136/jnnp-2022-330757
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发表时间:
2023-11
期刊:
Journal of neurology, neurosurgery, and psychiatry
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其他
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我们的研究调查了在第一次,第二次和第三次BNT 162 b2 mRNA疫苗接种前用抗CD 20单克隆抗体(Ab)ocrelizumab治疗的多发性硬化症(MS)患者队列中突破性SARS-CoV-2感染的发生率和临床结局。将临床结果与体液和细胞反应相关联。本研究是一项前瞻性、非随机、对照、多中心、观察性研究。对在首次BNT 162 b2 mRNA疫苗接种前接受ocrelizumab治疗至少12个月的诊断为MS的参与者进行了2021年1月至2022年6月的前瞻性随访。在54名参与者中,32名(59.3%)在研究期间出现了SARS-CoV-2 PCR检测阳性。在所有感染的参与者中观察到轻度感染。第三次接种后,未感染受试者的平均Ab水平高于感染受试者(54.3结合抗体单位(BAU)/mL vs 26.5 BAU/mL,p=0.030)。两组中刺突特异性CD 4+和CD 8 + T淋巴细胞之间的反应性差异不显著。研究结果表明,在ocrelizumab治疗的MS患者中,第三次SARS-CoV-2 mRNA疫苗接种后,突破性感染的发生率为59%,而不会导致严重的疾病过程。这些研究结果表明,需要不断发展的预防性治疗时,证明在保护严重的突破性感染的重要性。
Our study investigated the rate of breakthrough SARS-CoV-2 infection and clinical outcomes in a cohort of multiple sclerosis (MS) patients who were treated with the anti-CD20 monoclonal antibody (Ab), ocrelizumab, before first, second and third BNT162b2 mRNA vaccinations. To correlate clinical outcomes with the humoral and cellular response. The study was a prospective non-randomised controlled multicentre trial observational study. Participants with a diagnosis of MS who were treated for at least 12 months with ocrelizumab prior to the first BNT162b2 mRNA vaccination were prospectively followed up from January 2021 to June 2022. Out of 54 participants, 32 (59.3%) developed a positive SARS-CoV-2 PCR test in the study period. Mild infection was observed in all infected participants. After the third vaccination, the non-infected participants had higher mean Ab levels compared to the infected participants (54.3 binding antibody unit (BAU)/mL vs 26.5 BAU/mL, p=0.030). The difference in reactivity between spike-specific CD4+ and CD8+ T lymphocytes in the two groups was not significant. The study results demonstrate rates of 59% in breakthrough infections after the third SARS-CoV-2 mRNA vaccination in ocrelizumab-treated patients with MS, without resulting in critical disease courses. These findings suggest the need for continuous development of prophylactic treatments when proved important in the protection of severe breakthrough infection.
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