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.
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, F. S., 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, D., Argyraki, A., Cardellino, C. S., Koliakou, K., Katsigianni, E., 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, M. G., Eugen-Olsen, J., Kyprianou, M., Panagopoulos, P., Dalekos, G. N., Giamarellos-Bourboulis, E. J., Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial, <<NATURE MEDICINE>>, 2021; 27 (10): 1752-1760. [doi:10.1038/s41591-021-01499-z] [https://hdl.handle.net/10807/302540]
Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase 3 trial
Fantoni, Massimo;Dagna, Lorenzo;Cingolani, Antonella;
2021
Abstract
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.
| File | Dimensione | Formato | |
|---|---|---|---|
|
early.pdf
accesso aperto
Tipologia file ?:
Versione Editoriale (PDF)
Licenza:
Creative commons
Dimensione
5.65 MB
Formato
Adobe PDF
|
5.65 MB | Adobe PDF | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
