Carnero Contentti Edgar, López Pablo A, Pappolla Agustín, Alonso Ricardo, Silva Berenice, Deri Norma, Balbuena María E, Burgos Marcos, Luetic Geraldine, Alvez Pinheiro Amelia, Cabrera Mariela, Hryb Javier, Nofal Pedro, Pestchanker Claudia, Vrech Carlos, Tavolini Darío, Tkachuk Verónica, Zanga Gisela, Marrodan Mariano, Ysrraelit María Célica, Correale Jorge, Carrá Adriana, Federico Belén, Garcea Orlando, Fernandez Liguori Nora, Patrucco Liliana, Cristiano Edgardo, Giunta Diego, Alonso Serena Marina, Rojas Juan I
Department of Neurosciences, Neuroimmunology Unit, Hospital Aleman, Buenos Aires, Argentina.
Servicio de Neurología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.
Neurol Sci. 2024 Feb;45(2):379-389. doi: 10.1007/s10072-023-07282-x. Epub 2023 Dec 30.
We aimed to evaluate the incidence of SARS-CoV-2 breakthrough infection of SARS-CoV-2 vaccines in people with MS (PwMS) on high-efficacy disease-modifying therapies (HET) included in the national MS registry in Argentina (RelevarEM).
Non-interventional, retrospective cohort study that collected information directly from RelevarEM. Adult PwMS who had been treated for at least 6 months with a HET (ocrelizumab, natalizumab, alemtuzumab, cladribine) who had received at least two doses of SARS-CoV-2 vaccines available in Argentina were included. Full course of vaccination was considered after the second dose of the corresponding vaccines. Cumulative incidence of SARS-CoV-2 infection was reported for the whole cohort by Kaplan-Meier survival curves (which is expressed in percentage) as well as incidence density (which is expressed per 10.000 patients/day with 95% CI).
Two hundred twenty-eight PwMS were included. Most frequent first and second dose received was AstraZeneca vaccine, followed by Sputnik vaccine. Most frequent HETs used in included patients were cladribine in 79 (34.8%). We found an incidence density of breakthrough COVID-19 infection of 3.5 × 10.000 patients/day (95% CI 2.3-6.7) after vaccination in Argentina. We described the incidence rate after vaccination for every HET used, it being significantly higher for ocrelizumab compared with other HETs (p = 0.005). Only five patients presented a relapse during the follow-up period with no differences regarding the pre-vaccination period.
We found an incidence density of breakthrough COVID-19 infection of 3.5 × 10.000 patients/day (95% CI 2.3-6.7) after vaccination in Argentina.
我们旨在评估阿根廷全国多发性硬化症登记系统（RelevarEM）中接受高效疾病修正疗法（HET）的多发性硬化症患者（PwMS）感染SARS-CoV-2疫苗突破性感染的发生率。
非干预性回顾性队列研究，直接从RelevarEM收集信息。纳入接受过至少6个月HET（奥瑞珠单抗、那他珠单抗、阿仑单抗、克拉屈滨）治疗且已接种至少两剂阿根廷可用SARS-CoV-2疫苗的成年PwMS。第二剂相应疫苗接种后视为完成全程接种。通过Kaplan-Meier生存曲线（以百分比表示）以及发病密度（以每10000患者/天表示，95%置信区间）报告整个队列中SARS-CoV-2感染的累积发生率。
纳入228例PwMS。最常接种的第一剂和第二剂疫苗是阿斯利康疫苗，其次是卫星五号疫苗。纳入患者中最常使用的HET是克拉屈滨，共79例（34.8%）。我们发现在阿根廷接种疫苗后，突破性新冠病毒感染的发病密度为3.5/10000患者/天（95%置信区间2.3 - 6.7）。我们描述了每种使用的HET接种疫苗后的发病率，奥瑞珠单抗的发病率显著高于其他HET（p = 0.005）。随访期间仅有5例患者出现复发，与接种疫苗前相比无差异。
我们发现在阿根廷接种疫苗后，突破性新冠病毒感染的发病密度为3.5/10000患者/天（95%置信区间2.3 - 6.7）。
