Alunno Alessia, Najm Aurélie, Mariette Xavier, De Marco Gabriele, Emmel Jenny, Mason Laura, McGonagle Dennis G, Machado Pedro M
Internal Medicine and Nephrology Unit, Department of Life, Health & Environmental Sciences, University of L'Aquila, L'Aquila, Italy
Institute of Infection, Immunity and Inflammation, College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
RMD Open. 2021 Oct;7(3). doi: 10.1136/rmdopen-2021-001899.
To update the EULAR 2020 systematic literature review (SLR) on efficacy and safety of immunomodulatory agents in SARS-CoV-2 infection.
As part of a EULAR taskforce, a systematic literature search update was conducted from 11 December 2020 to 14 July 2021. Two reviewers independently identified eligible studies and extracted data on efficacy and safety of immunomodulatory agents used therapeutically in SARS-CoV-2 infection at any stage of disease. The risk of bias (RoB) was assessed with validated tools.
Of the 26 959 records, 520 articles were eligible for inclusion. Studies were mainly at high or unclear RoB. New randomised controlled trials (RCTs) on tocilizumab clarified its benefit in patients with severe and critical COVID-19, mainly if associated with glucocorticoids. There are emergent data on the usefulness of baricitinib and tofacitinib in severe COVID-19. Other therapeutic strategies such as the use of convalescent plasma and anti-SARS-CoV-2 monoclonal antibodies showed efficacy in subjects not mounting normal anti-SARS-CoV-2 antibody responses.
This new SLR confirms that some immunomodulators (tocilizumab and JAK inhibitors) have a role for treating severe and critical COVID-19. Although better evidence is available compared with the previous SLR, the need of RCT with combination therapy (glucocorticoids+anti-cytokines) versus monotherapy with glucocorticoids still remains alongside the need for standardisation of inclusion criteria and outcomes to ultimately improve the care and prognosis of affected people. This SLR informed the 2021 update of the EULAR points to consider on the use of immunomodulatory therapies in COVID-19.
更新欧洲抗风湿病联盟（EULAR）2020年关于免疫调节药物在新型冠状病毒肺炎（SARS-CoV-2）感染中的疗效和安全性的系统文献综述。
作为EULAR工作组的一部分，于2020年12月11日至2021年7月14日进行了系统文献检索更新。两名评审员独立识别符合条件的研究，并提取有关在疾病任何阶段用于治疗SARS-CoV-2感染的免疫调节药物的疗效和安全性的数据。使用经过验证的工具评估偏倚风险（RoB）。
在26959条记录中，有520篇文章符合纳入标准。研究的偏倚风险主要为高或不明确。关于托珠单抗的新随机对照试验（RCT）阐明了其在重症和危重症2019冠状病毒病（COVID-19）患者中的益处，主要是与糖皮质激素联合使用时。关于巴瑞替尼和托法替布在重症COVID-19中的有效性有新出现的数据。其他治疗策略，如使用康复期血浆和抗SARS-CoV-2单克隆抗体，在未产生正常抗SARS-CoV-2抗体反应的受试者中显示出疗效。
这项新的系统文献综述证实，一些免疫调节剂（托珠单抗和JAK抑制剂）在治疗重症和危重症COVID-19中具有作用。尽管与之前的系统文献综述相比有了更好的证据，但仍需要进行联合治疗（糖皮质激素+抗细胞因子）与糖皮质激素单药治疗的随机对照试验，同时需要标准化纳入标准和结局指标，以最终改善患者的治疗和预后。本系统文献综述为EULAR 2021年关于在COVID-19中使用免疫调节疗法的要点更新提供了信息。
