TY - JOUR
T1 - Tocilizumab and steroid treatment in patients with COVID-19 pneumonia
AU - Mikulska, Malgorzata
AU - Nicolini, Laura Ambra
AU - Signori, Alessio
AU - Di Biagio, Antonio
AU - Sepulcri, Chiara
AU - Russo, Chiara
AU - Dettori, Silvia
AU - Berruti, Marco
AU - Sormani, Maria Pia
AU - Giacobbe, Daniele Roberto
AU - Vena, Antonio
AU - De Maria, Andrea
AU - Dentone, Chiara
AU - Taramasso, Lucia
AU - Mirabella, Michele
AU - Magnasco, Laura
AU - Mora, Sara
AU - Delfino, Emanuele
AU - Toscanini, Federica
AU - Balletto, Elisa
AU - Alessandrini, Anna Ida
AU - Baldi, Federico
AU - Briano, Federica
AU - Camera, Marco
AU - Dodi, Ferdinando
AU - Ferrazin, Antonio
AU - Labate, Laura
AU - Mazzarello, Giovanni
AU - Pincino, Rachele
AU - Portunato, Federica
AU - Tutino, Stefania
AU - Barisione, Emanuela
AU - Bruzzone, Bianca
AU - Orsi, Andrea
AU - Schenone, Eva
AU - Rosseti, Nirmala
AU - Sasso, Elisabetta
AU - Rin, Giorgio Da
AU - Pelosi, Paolo
AU - Beltramini, Sabrina
AU - Giacomini, Mauro
AU - Icardi, Giancarlo
AU - Gratarola, Angelo
AU - Bassetti, Matteo
N1 - Publisher Copyright:
© 2020 Mikulska et al.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/8
Y1 - 2020/8
N2 - Introduction: Coronavirus disease 2019 (COVID-19) can lead to respiratory failure due to severe immune response. Treatment targeting this immune response might be beneficial but there is limited evidence on its efficacy. The aim of this study was to determine if early treatment of patients with COVID-19 pneumonia with tocilizumab and/or steroids was associated with better outcome. Methods: This observational single-center study included patients with COVID-19 pneumonia who were not intubated and received either standard of care (SOC, controls) or SOC plus early (within 3 days from hospital admission) anti-inflammatory treatment. SOC consisted of hydroxychloroquine 400mg bid plus, in those admitted before March 24th, also darunavir/ritonavir. Anti-inflammatory treatment consisted of either tocilizumab (8mg/kg intravenously or 162mg subcutaneously) or methylprednisolone 1 mg/kg for 5 days or both. Failure was defined as intubation or death, and the endpoints were failure-free survival (primary endpoint) and overall survival (secondary) at day 30. Difference between the groups was estimated as Hazard Ratio by a propensity score weighted Cox regression analysis (HROW). Results: Overall, 196 adults were included in the analyses. They were mainly male (67.4%), with comorbidities (78.1%) and severe COVID-19 pneumonia (83.7%). Median age was 67.9 years (range, 30-100) and median PaO2/FiO2 200 mmHg (IQR 133-289). Among them, 130 received early anti-inflammatory treatment with: tocilizumab (n = 29, 22.3%), methylprednisolone (n = 45, 34.6%), or both (n = 56, 43.1%). The adjusted failure-free survival among tocilizumab/methylprednisolone/SOC treated patients vs. SOC was 80.8% (95%CI, 72.8-86.7) vs. 64.1% (95%CI, 51.3-74.0), HROW 0.48, 95%CI, 0.23-0.99; p = 0.049. The overall survival among tocilizumab/methylprednisolone/SOC patients vs. SOC was 85.9% (95%CI, 80.7-92.6) vs. 71.9% (95%CI, 46-73), HROW 0.41, 95%CI: 0.19-0.89, p = 0.025. Conclusion: Early adjunctive treatment with tocilizumab, methylprednisolone or both may improve outcomes in non-intubated patients with COVID-19 pneumonia.
AB - Introduction: Coronavirus disease 2019 (COVID-19) can lead to respiratory failure due to severe immune response. Treatment targeting this immune response might be beneficial but there is limited evidence on its efficacy. The aim of this study was to determine if early treatment of patients with COVID-19 pneumonia with tocilizumab and/or steroids was associated with better outcome. Methods: This observational single-center study included patients with COVID-19 pneumonia who were not intubated and received either standard of care (SOC, controls) or SOC plus early (within 3 days from hospital admission) anti-inflammatory treatment. SOC consisted of hydroxychloroquine 400mg bid plus, in those admitted before March 24th, also darunavir/ritonavir. Anti-inflammatory treatment consisted of either tocilizumab (8mg/kg intravenously or 162mg subcutaneously) or methylprednisolone 1 mg/kg for 5 days or both. Failure was defined as intubation or death, and the endpoints were failure-free survival (primary endpoint) and overall survival (secondary) at day 30. Difference between the groups was estimated as Hazard Ratio by a propensity score weighted Cox regression analysis (HROW). Results: Overall, 196 adults were included in the analyses. They were mainly male (67.4%), with comorbidities (78.1%) and severe COVID-19 pneumonia (83.7%). Median age was 67.9 years (range, 30-100) and median PaO2/FiO2 200 mmHg (IQR 133-289). Among them, 130 received early anti-inflammatory treatment with: tocilizumab (n = 29, 22.3%), methylprednisolone (n = 45, 34.6%), or both (n = 56, 43.1%). The adjusted failure-free survival among tocilizumab/methylprednisolone/SOC treated patients vs. SOC was 80.8% (95%CI, 72.8-86.7) vs. 64.1% (95%CI, 51.3-74.0), HROW 0.48, 95%CI, 0.23-0.99; p = 0.049. The overall survival among tocilizumab/methylprednisolone/SOC patients vs. SOC was 85.9% (95%CI, 80.7-92.6) vs. 71.9% (95%CI, 46-73), HROW 0.41, 95%CI: 0.19-0.89, p = 0.025. Conclusion: Early adjunctive treatment with tocilizumab, methylprednisolone or both may improve outcomes in non-intubated patients with COVID-19 pneumonia.
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U2 - 10.1371/journal.pone.0237831
DO - 10.1371/journal.pone.0237831
M3 - Article
C2 - 32817707
AN - SCOPUS:85089769235
VL - 15
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 8 August
M1 - e0237831
ER -