在当前的COVID-19大流行中,诊断为多发性硬化症(MS)的患者被认为是最优先考虑的类别之一,被认为是极其脆弱的人。出于这个原因,这些患者强烈建议使用基于mRNA的COVID-19疫苗。尽管在基于mRNA的COVID-19疫苗的有效性和安全性方面取得了令人鼓舞的结果,到目前为止,在脆弱的人群中,包括被诊断为MS的患者,这些信息相当有限。我们进行了一项回顾性观察性研究,目的是通过检索在医院A.O.R.N.多发性硬化中心接受治疗和接种的MS患者的真实数据来评估基于mRNA的COVID-19疫苗的安全性。A.卡达利。检索到接受第一剂基于mRNA的COVID-19疫苗的MS患者的110份医疗记录(63%为女性;平均年龄:45.9岁)。在这些病人中,288也接受了第二剂量。所有患者都接受了Pfizer-BioNTech疫苗。复发缓解型多发性硬化(RRSM)是MS的最常见形式。70%的患者的扩展残疾状态量表(EDSS)值为3.0。大多数患者在研究期间接受了疾病改良疗法(DMT),主要是干扰素β1-a,富马酸二甲酯,那他珠单抗和芬戈莫德.总的来说,确定了913个AEFI,其中539人在第一次接种疫苗后,374人在第二次接种疫苗后。这些AEFI中的大多数被归类为短期的,因为它们发生在最初的72小时内。最常见的不良事件是注射部位的疼痛,流感样症状,和头痛。第二剂量后比第一剂量后更频繁地报告发热。首次给药后3例患者发生SARS-CoV-2感染。利用以前年度(2017-2020年)的历史数据,2021年的复发率较低。最后,评估与AEFI发生相关因素的多变量分析结果显示,年龄有统计学意义,性别,和奥利珠单抗治疗(p<0.05)。总之,我们的结果表明,辉瑞BioNTech疫苗对MS患者是安全的,与普通人群中已经检测到的AEFI相关。非常需要更大的观察性研究以及更长的随访和流行病学研究。
In the current COVID-19 pandemic, patients diagnosed with multiple sclerosis (MS) are considered to be one of the highest priority categories, being recognized as extremely vulnerable people. For this reason, mRNA-based COVID-19 vaccines are strongly recommended for these patients. Despite encouraging results on the efficacy and safety profile of mRNA-based COVID-19 vaccines, to date, in frail populations, including patients diagnosed with MS, this information is rather limited. We carried out a retrospective observational
study with the aim to evaluate the safety profile of mRNA-based COVID-19 vaccines by retrieving real-life data of MS patients who were treated and vaccinated at the Multiple Sclerosis Center of the Hospital A.O.R.N. A. Cardarelli. Three-hundred and ten medical records of MS patients who received the first dose of the mRNA-based COVID-19 vaccine were retrieved (63% female; mean age: 45.9 years). Of these patients, 288 also received the second dose. All patients received the Pfizer-BioNTech vaccine. Relapsing-Remitting Multiple Sclerosis (RRSM) was the most common form of MS. The Expanded Disability Status Scale (EDSS) values were <3.0 in 70% of patients. The majority of patients received a Disease Modifying Therapy (DMT) during the
study period, mainly interferon beta 1-a, dimethyl fumarate, and natalizumab and fingolimod. Overall, 913 AEFIs were identified, of which 539 were after the first dose of the vaccine and 374 after the second dose. The majority of these AEFIs were classified as short-term since they occurred within the first 72 h. The most common identified adverse events were pain at injection site, flu-like symptoms, and headache. Fever was reported more frequently after the second dose than after the first dose. SARS-CoV-2 infection occurred in 3 patients after the first dose. Using historical data of previous years (2017−2020), the relapses’ rate during 2021 was found to be lower. Lastly, the results of the multivariable analysis that assessed factors associated with the occurrence of AEFIs revealed a statistical significance for age, sex, and therapy with ocrelizumab (p < 0.05). In conclusion, our results indicated that Pfizer-BioNTech vaccine was safe for MS patients, being associated with AEFIs already detected in the general population. Larger observational studies with longer follow-up and epidemiological studies are strongly needed.