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Tocilizumab and steroid treatment in patients with COVID-19 pneumonia.
PLoS One. 2020; 15(8):e0237831.Plos

Abstract

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.

Authors+Show Affiliations

Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Section of Biostatistics, Department of Health Sciences, University of Genova, Genova, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Section of Biostatistics, Department of Health Sciences, University of Genova, Genova, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Department of Informatics, Bioengineering, Robotics and System Engineering, University of Genoa, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy. Infectious Diseases Unit, University of Campania Luigi Vanvitelli, Napoli, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy.Interventional Pulmonology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Hygiene Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.Hygiene Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy. Department of Health Sciences, University of Genoa, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.Pharmacy Complex Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.Medicine Laboratory, IRCCS Ospedale Policlinico San Martino, Genova, Italy.Department of Surgical Sciences and Integrated Diagnostics, University of Genova, Genova, Italy. Anesthesia and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.Pharmacy Complex Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.Department of Informatics, Bioengineering, Robotics and System Engineering, University of Genoa, Genoa, Italy.Hygiene Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy. Department of Health Sciences, University of Genoa, Genoa, Italy.Department of Emergency and Urgency, San Martino Policlinico Hospital, IRCCS for Oncology and Neurosciences, Genoa, Italy.Division of Infectious Diseases, Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

32817707

Citation

Mikulska, Malgorzata, et al. "Tocilizumab and Steroid Treatment in Patients With COVID-19 Pneumonia." PloS One, vol. 15, no. 8, 2020, pp. e0237831.
Mikulska M, Nicolini LA, Signori A, et al. Tocilizumab and steroid treatment in patients with COVID-19 pneumonia. PLoS ONE. 2020;15(8):e0237831.
Mikulska, M., Nicolini, L. A., Signori, A., Di Biagio, A., Sepulcri, C., Russo, C., Dettori, S., Berruti, M., Sormani, M. P., Giacobbe, D. R., Vena, A., De Maria, A., Dentone, C., Taramasso, L., Mirabella, M., Magnasco, L., Mora, S., Delfino, E., Toscanini, F., ... Bassetti, M. (2020). Tocilizumab and steroid treatment in patients with COVID-19 pneumonia. PloS One, 15(8), e0237831. https://doi.org/10.1371/journal.pone.0237831
Mikulska M, et al. Tocilizumab and Steroid Treatment in Patients With COVID-19 Pneumonia. PLoS ONE. 2020;15(8):e0237831. PubMed PMID: 32817707.
* Article titles in AMA citation format should be in sentence-case
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 - Da Rin,Giorgio, AU - Pelosi,Paolo, AU - Beltramini,Sabrina, AU - Giacomini,Mauro, AU - Icardi,Giancarlo, AU - Gratarola,Angelo, AU - Bassetti,Matteo, Y1 - 2020/08/20/ PY - 2020/06/24/received PY - 2020/08/02/accepted PY - 2020/8/21/entrez PY - 2020/8/21/pubmed PY - 2020/9/2/medline SP - e0237831 EP - e0237831 JF - PloS one JO - PLoS ONE VL - 15 IS - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/32817707/Tocilizumab_and_steroid_treatment_in_patients_with_COVID_19_pneumonia_ L2 - https://dx.plos.org/10.1371/journal.pone.0237831 DB - PRIME DP - Unbound Medicine ER -