{"title":"一组接受克拉利宾片治疗的多发性硬化症患者在完全接种 COVID-19 疫苗后的体液免疫反应和淋巴细胞水平。","authors":"Christoph Grothe, Falk Steffen, Stefan Bittner","doi":"10.1177/11795735211060118","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with multiple sclerosis (MS) receiving immunomodulatory drugs were excluded from clinical trials on COVID-19 vaccines. Therefore, data regarding the efficacy of COVID-19 vaccines to induce humoral immunity in MS patients treated with B- and T-cell depleting agents is urgently warranted. Cladribine tablets are a high-efficacy disease-modifying treatment that exerts its therapeutic effect via sustained but transient lymphocyte depletion.</p><p><strong>Aim: </strong>We report humoral responses in a German cohort of MS patients treated with cladribine tablets.</p><p><strong>Methods: </strong>This retrospective analysis included patients ≥18 years who were treated with cladribine tablets for relapsing MS in the first or second year and were fully vaccinated against COVID-19. Two weeks after the second vaccination at the earliest, blood samples were obtained for the assessment of anti-SARS-CoV-2 IgG antibodies, lymphocyte counts, B-cells, CD4<sup>+</sup> T-cells, and CD8<sup>+</sup> T-cells. Anti-SARS-CoV-2 IgG antibodies were quantified with the LIAISON<sup>®</sup> SARS-CoV-2 TrimericS IgG assay. Positivity was defined at a cutoff value of 33.8 BAU/mL.</p><p><strong>Results: </strong>In total, 38 patients (73.7% female, aged 23-66 years) were included in the analysis. Ten patients (26.3%) were treatment-naïve before initiating treatment with cladribine tablets. Most patients (84.2%) received mRNA vaccines. The time between the last dose of cladribine tablets and vaccination ranged between 2 and 96 weeks. Six patients (15.8%) were vaccinated within 4 weeks of their last cladribine dose. All patients achieved positive anti-SARS-CoV-2 IgG antibody levels. Humoral immune response was independent of age, time of vaccination in relation to the last cladribine dose, lymphocyte counts as well as B- and T-cell counts.</p><p><strong>Conclusions: </strong>Treatment with cladribine tablets did not impair humoral response to COVID-19 vaccination. Time since last cladribine dose, age, prior therapy, lymphocyte count as well as B- and T-cell counts had no effect on seropositivity of anti-SARS-CoV-2 IgG antibodies.</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":" ","pages":"11795735211060118"},"PeriodicalIF":4.6000,"publicationDate":"2021-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/40/10.1177_11795735211060118.PMC8647228.pdf","citationCount":"0","resultStr":"{\"title\":\"Humoral immune response and lymphocyte levels after complete vaccination against COVID-19 in a cohort of multiple sclerosis patients treated with cladribine tablets.\",\"authors\":\"Christoph Grothe, Falk Steffen, Stefan Bittner\",\"doi\":\"10.1177/11795735211060118\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients with multiple sclerosis (MS) receiving immunomodulatory drugs were excluded from clinical trials on COVID-19 vaccines. Therefore, data regarding the efficacy of COVID-19 vaccines to induce humoral immunity in MS patients treated with B- and T-cell depleting agents is urgently warranted. Cladribine tablets are a high-efficacy disease-modifying treatment that exerts its therapeutic effect via sustained but transient lymphocyte depletion.</p><p><strong>Aim: </strong>We report humoral responses in a German cohort of MS patients treated with cladribine tablets.</p><p><strong>Methods: </strong>This retrospective analysis included patients ≥18 years who were treated with cladribine tablets for relapsing MS in the first or second year and were fully vaccinated against COVID-19. Two weeks after the second vaccination at the earliest, blood samples were obtained for the assessment of anti-SARS-CoV-2 IgG antibodies, lymphocyte counts, B-cells, CD4<sup>+</sup> T-cells, and CD8<sup>+</sup> T-cells. Anti-SARS-CoV-2 IgG antibodies were quantified with the LIAISON<sup>®</sup> SARS-CoV-2 TrimericS IgG assay. Positivity was defined at a cutoff value of 33.8 BAU/mL.</p><p><strong>Results: </strong>In total, 38 patients (73.7% female, aged 23-66 years) were included in the analysis. Ten patients (26.3%) were treatment-naïve before initiating treatment with cladribine tablets. Most patients (84.2%) received mRNA vaccines. The time between the last dose of cladribine tablets and vaccination ranged between 2 and 96 weeks. Six patients (15.8%) were vaccinated within 4 weeks of their last cladribine dose. All patients achieved positive anti-SARS-CoV-2 IgG antibody levels. Humoral immune response was independent of age, time of vaccination in relation to the last cladribine dose, lymphocyte counts as well as B- and T-cell counts.</p><p><strong>Conclusions: </strong>Treatment with cladribine tablets did not impair humoral response to COVID-19 vaccination. Time since last cladribine dose, age, prior therapy, lymphocyte count as well as B- and T-cell counts had no effect on seropositivity of anti-SARS-CoV-2 IgG antibodies.</p>\",\"PeriodicalId\":2,\"journal\":{\"name\":\"ACS Applied Bio Materials\",\"volume\":\" \",\"pages\":\"11795735211060118\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2021-12-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/40/10.1177_11795735211060118.PMC8647228.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"ACS Applied Bio Materials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/11795735211060118\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2021/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"MATERIALS SCIENCE, BIOMATERIALS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"ACS Applied Bio Materials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/11795735211060118","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2021/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"MATERIALS SCIENCE, BIOMATERIALS","Score":null,"Total":0}
引用次数: 0
摘要
背景：接受免疫调节药物治疗的多发性硬化症（MS）患者被排除在 COVID-19 疫苗的临床试验之外。因此，迫切需要获得有关 COVID-19 疫苗对接受 B 细胞和 T 细胞耗竭药物治疗的多发性硬化症患者诱导体液免疫的功效的数据。克拉利宾片是一种高效的疾病改变疗法，它通过持续但短暂的淋巴细胞耗竭发挥治疗效果。目的：我们报告了德国一组接受克拉利宾片治疗的多发性硬化症患者的体液反应：这项回顾性分析包括年龄≥18岁的患者，他们在第一年或第二年接受了复发性多发性硬化症的克拉利宾片治疗，并完全接种了COVID-19疫苗。最早在第二次接种后两周采集血液样本，用于评估抗 SARS-CoV-2 IgG 抗体、淋巴细胞计数、B 细胞、CD4+ T 细胞和 CD8+ T 细胞。抗 SARS-CoV-2 IgG 抗体用 LIAISON® SARS-CoV-2 TrimericS IgG 检测法进行量化。阳性定义为 33.8 BAU/mL：共有 38 名患者（73.7% 为女性，年龄在 23-66 岁之间）参与了分析。10名患者（26.3%）在开始接受克拉利宾片治疗前是治疗无效者。大多数患者（84.2%）接种了 mRNA 疫苗。最后一次服用克拉利宾片和接种疫苗之间的间隔时间为 2 至 96 周。有 6 名患者（15.8%）在最后一次服用克拉利宾后 4 周内接种了疫苗。所有患者的抗 SARS-CoV-2 IgG 抗体水平均呈阳性。体液免疫反应与年龄、接种疫苗的时间（与最后一次服用克拉利宾有关）、淋巴细胞计数以及 B 细胞和 T 细胞计数无关：结论：使用克拉利宾片治疗不会影响接种 COVID-19 疫苗后的体液免疫反应。最后一次服用克拉利宾的时间、年龄、之前的治疗、淋巴细胞计数以及B细胞和T细胞计数对抗SARS-CoV-2 IgG抗体的血清阳性率没有影响。
Humoral immune response and lymphocyte levels after complete vaccination against COVID-19 in a cohort of multiple sclerosis patients treated with cladribine tablets.
Background: Patients with multiple sclerosis (MS) receiving immunomodulatory drugs were excluded from clinical trials on COVID-19 vaccines. Therefore, data regarding the efficacy of COVID-19 vaccines to induce humoral immunity in MS patients treated with B- and T-cell depleting agents is urgently warranted. Cladribine tablets are a high-efficacy disease-modifying treatment that exerts its therapeutic effect via sustained but transient lymphocyte depletion.
Aim: We report humoral responses in a German cohort of MS patients treated with cladribine tablets.
Methods: This retrospective analysis included patients ≥18 years who were treated with cladribine tablets for relapsing MS in the first or second year and were fully vaccinated against COVID-19. Two weeks after the second vaccination at the earliest, blood samples were obtained for the assessment of anti-SARS-CoV-2 IgG antibodies, lymphocyte counts, B-cells, CD4+ T-cells, and CD8+ T-cells. Anti-SARS-CoV-2 IgG antibodies were quantified with the LIAISON® SARS-CoV-2 TrimericS IgG assay. Positivity was defined at a cutoff value of 33.8 BAU/mL.
Results: In total, 38 patients (73.7% female, aged 23-66 years) were included in the analysis. Ten patients (26.3%) were treatment-naïve before initiating treatment with cladribine tablets. Most patients (84.2%) received mRNA vaccines. The time between the last dose of cladribine tablets and vaccination ranged between 2 and 96 weeks. Six patients (15.8%) were vaccinated within 4 weeks of their last cladribine dose. All patients achieved positive anti-SARS-CoV-2 IgG antibody levels. Humoral immune response was independent of age, time of vaccination in relation to the last cladribine dose, lymphocyte counts as well as B- and T-cell counts.
Conclusions: Treatment with cladribine tablets did not impair humoral response to COVID-19 vaccination. Time since last cladribine dose, age, prior therapy, lymphocyte count as well as B- and T-cell counts had no effect on seropositivity of anti-SARS-CoV-2 IgG antibodies.
期刊介绍：
ACS Applied Bio Materials is an interdisciplinary journal publishing original research covering all aspects of biomaterials and biointerfaces including and beyond the traditional biosensing, biomedical and therapeutic applications.
The journal is devoted to reports of new and original experimental and theoretical research of an applied nature that integrates knowledge in the areas of materials, engineering, physics, bioscience, and chemistry into important bio applications. The journal is specifically interested in work that addresses the relationship between structure and function and assesses the stability and degradation of materials under relevant environmental and biological conditions.
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