Grothe Christoph, Steffen Falk, Bittner Stefan
GFO Kliniken Troisdorf, Troisdorf (Sieglar), Germany.
Klinik und Poliklinik für Neurologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Germany.
J Cent Nerv Syst Dis. 2021 Dec 2;13:11795735211060118. doi: 10.1177/11795735211060118. eCollection 2021.
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.
We report humoral responses in a German cohort of MS patients treated with cladribine tablets.
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.
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.
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.
接受免疫调节药物治疗的多发性硬化症（MS）患者被排除在新冠病毒疫苗的临床试验之外。因此，迫切需要有关新冠病毒疫苗在接受B细胞和T细胞耗竭剂治疗的MS患者中诱导体液免疫功效的数据。克拉屈滨片是一种高效的疾病改善治疗药物，通过持续但短暂的淋巴细胞耗竭发挥其治疗作用。
我们报告了德国一组接受克拉屈滨片治疗的MS患者的体液反应。
这项回顾性分析纳入了年龄≥18岁、在第一年或第二年接受克拉屈滨片治疗复发型MS且已完成新冠病毒疫苗全程接种的患者。最早在第二次接种后两周采集血样，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。使用LIAISON SARS-CoV-2 TrimericS IgG检测法对抗SARS-CoV-2 IgG抗体进行定量。阳性定义为截断值33.8 BAU/mL。
总共38例患者（73.7%为女性，年龄23 - 66岁）纳入分析。10例患者（26.3%）在开始使用克拉屈滨片治疗前未接受过治疗。大多数患者（84.2%）接种的是mRNA疫苗。最后一剂克拉屈滨片与接种疫苗之间的时间间隔为2至96周。6例患者（15.8%）在最后一剂克拉屈滨片后的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、接种疫苗时间与最后一剂克拉屈滨片的关系、淋巴细胞计数以及B细胞和T细胞计数无关。
克拉屈滨片治疗并未损害对新冠病毒疫苗接种的体液反应。自最后一剂克拉屈滨片以来的时间、年龄、既往治疗、淋巴细胞计数以及B细胞和T细胞计数对抗SARS-CoV-2 IgG抗体的血清阳性率均无影响。
