Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial.
Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial.
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DOI：
10.1038/s41591-021-01499-z
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发表时间：
2021-10
期刊：
影响因子：
82.9
通讯作者：
Giamarellos-Bourboulis EJ
中科院分区：
文献类型：
--
作者：
Kyriazopoulou E;Poulakou G;Milionis H;Metallidis S;Adamis G;Tsiakos K;Fragkou A;Rapti A;Damoulari C;Fantoni M;Kalomenidis I;Chrysos G;Angheben A;Kainis I;Alexiou Z;Castelli F;Serino FS;Tsilika M;Bakakos P;Nicastri E;Tzavara V;Kostis E;Dagna L;Koufargyris P;Dimakou K;Savvanis S;Tzatzagou G;Chini M;Cavalli G;Bassetti M;Katrini K;Kotsis V;Tsoukalas G;Selmi C;Bliziotis I;Samarkos M;Doumas M;Ktena S;Masgala A;Papanikolaou I;Kosmidou M;Myrodia DM;Argyraki A;Cardellino CS;Koliakou K;Katsigianni EI;Rapti V;Giannitsioti E;Cingolani A;Micha S;Akinosoglou K;Liatsis-Douvitsas O;Symbardi S;Gatselis N;Mouktaroudi M;Ippolito G;Florou E;Kotsaki A;Netea MG;Eugen-Olsen J;Kyprianou M;Panagopoulos P;Dalekos GN;Giamarellos-Bourboulis EJ
可溶性尿激酶纤溶酶原激活剂受体（suPAR）血清水平的早期升高表明2019冠状病毒病（COVID-19）进展为呼吸衰竭的风险增加。SAVE-MORE双盲、随机对照试验评估了IL-1α/β抑制剂anakinra在594例血浆suPAR≥6 ng ml - 1,85.9% （n = 510）接受地塞米松治疗的COVID-19患者进展为呼吸衰竭风险的疗效和安全性。在第28天，与安慰剂相比，anakinra的临床状况更差的调整比例赔率（由11分的世界卫生组织临床进展量表（WHO-CPS）评估）为0.36（95%置信区间0.26-0.50）。安慰剂组和阿那金组在第28天较基线的WHO-CPS中位数下降分别为3和4点（优势比(OR) = 0.40, P < 0.0001）；在第7天，序贯器官衰竭评估（SOFA）评分较基线分别下降0分和1分（OR = 0.63, P = 0.004）。28天死亡率降低（风险比= 0.45,P = 0.045），住院时间缩短。SAVE-MORE 3期研究表明，IL-1α/β抑制剂anakinra对血清可溶性纤溶酶原激活物受体高水平的COVID-19患者有效。
Early increase of soluble urokinase plasminogen activator receptor (suPAR) serum levels is indicative of increased risk of progression of coronavirus disease 2019 (COVID-19) to respiratory failure. The SAVE-MORE double-blind, randomized controlled trial evaluated the efficacy and safety of anakinra, an IL-1α/β inhibitor, in 594 patients with COVID-19 at risk of progressing to respiratory failure as identified by plasma suPAR ≥6 ng ml−1, 85.9% (n = 510) of whom were receiving dexamethasone. At day 28, the adjusted proportional odds of having a worse clinical status (assessed by the 11-point World Health Organization Clinical Progression Scale (WHO-CPS)) with anakinra, as compared to placebo, was 0.36 (95% confidence interval 0.26–0.50). The median WHO-CPS decrease on day 28 from baseline in the placebo and anakinra groups was 3 and 4 points, respectively (odds ratio (OR) = 0.40, P < 0.0001); the respective median decrease of Sequential Organ Failure Assessment (SOFA) score on day 7 from baseline was 0 and 1 points (OR = 0.63, P = 0.004). Twenty-eight-day mortality decreased (hazard ratio = 0.45, P = 0.045), and hospital stay was shorter. The SAVE-MORE phase 3 study demonstrates the efficacy of anakinra, an IL-1α/β inhibitor, in patients with COVID-19 and high serum levels of soluble plasminogen activator receptor.
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