Merck Serono S.p.A., An Affiliate of Merck KGaA, Rome, Italy; Department of Health Sciences, University of Genoa, Via Pastore 1, Genoa 16132, Italy.
Department of Health Sciences, University of Genoa, Via Pastore 1, Genoa 16132, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Mult Scler Relat Disord. 2022 Dec;68:104156. doi: 10.1016/j.msard.2022.104156. Epub 2022 Sep 5.
The Coronavirus 19 pandemic has raised new relevant questions regarding the management of patients with multiple sclerosis (pwMS) treated with different immunosuppressive and immunomodulant drugs. In most COVID-19 outcomes analyses, due to the small available sample size, patients treated with cladribine were grouped with patients treated with other treatments.
Three major databases (PubMed, Scopus and Web of Science) and the most recent MS congress libraries were searched for extracting original articles on COVID-19 and multiple sclerosis. The key inclusion criteria were the presence of data on pwMS treated with cladribine and with documented positivity for COVID-19. The quality of the included studies was evaluated using a modified version of the Dutch Cochrane center critical review checklist proposed by MOOSE. A common-effect meta-analysis was used for estimating the pooled proportion of patients with severe events (hospitalizations, pneumonia, ICU admissions and deaths) and heterogeneity was assessed by the I statistic.
13 articles were included in the analysis and the median quality of the articles reached a level of 4. The selected studies included 5138 patients with COVID-19, of whom 107 (2.1%) were treated with cladribine. Pooled estimates of hospitalization and death were 9.36% and 0% for patients treated with cladribine, 14.98% and 2.66% for pwMS under other treatments.
These results indicate that pwMS treated with cladribine are not at a greater risk of developing a severe form of COVID-19.
The protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022329464).
新冠肺炎疫情提出了一些与多发性硬化症(pwMS)患者管理相关的新问题,这些患者接受了不同的免疫抑制和免疫调节药物治疗。在大多数 COVID-19 结局分析中,由于可用样本量较小,接受克拉屈滨治疗的患者与接受其他治疗的患者被归为一组。
在 PubMed、Scopus 和 Web of Science 三大数据库和最近的多发性硬化症大会文库中检索了关于 COVID-19 和多发性硬化症的原始文章,以提取相关数据。主要纳入标准为纳入接受克拉屈滨治疗且 COVID-19 检测结果阳性的 pwMS 的研究。使用 MOOSE 提出的荷兰 Cochrane 中心改良关键评价清单对纳入研究的质量进行评估。使用合并效应荟萃分析来估计严重事件(住院、肺炎、入住重症监护病房和死亡)的患者合并比例,并通过 I 统计量评估异质性。
纳入了 13 项研究进行分析,文章的平均质量达到了 4 级。所选研究共纳入了 5138 例 COVID-19 患者,其中 107 例(2.1%)接受了克拉屈滨治疗。接受克拉屈滨治疗的患者的住院和死亡合并估计值分别为 9.36%和 0%,而接受其他治疗的 pwMS 患者的住院和死亡合并估计值分别为 14.98%和 2.66%。
这些结果表明,接受克拉屈滨治疗的 pwMS 发生严重 COVID-19 的风险并未增加。
该方案已在国际前瞻性系统评价注册库(PROSPERO:CRD42022329464)中进行了注册。