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Tocilizumab and steroid treatment in patients with COVID-19 pneumonia.

Authors :
Malgorzata Mikulska
Laura Ambra Nicolini
Alessio Signori
Antonio Di Biagio
Chiara Sepulcri
Chiara Russo
Silvia Dettori
Marco Berruti
Maria Pia Sormani
Daniele Roberto Giacobbe
Antonio Vena
Andrea De Maria
Chiara Dentone
Lucia Taramasso
Michele Mirabella
Laura Magnasco
Sara Mora
Emanuele Delfino
Federica Toscanini
Elisa Balletto
Anna Ida Alessandrini
Federico Baldi
Federica Briano
Marco Camera
Ferdinando Dodi
Antonio Ferrazin
Laura Labate
Giovanni Mazzarello
Rachele Pincino
Federica Portunato
Stefania Tutino
Emanuela Barisione
Bianca Bruzzone
Andrea Orsi
Eva Schenone
Nirmala Rosseti
Elisabetta Sasso
Giorgio Da Rin
Paolo Pelosi
Sabrina Beltramini
Mauro Giacomini
Giancarlo Icardi
Angelo Gratarola
Matteo Bassetti
Source :
PLoS ONE, Vol 15, Iss 8, p e0237831 (2020)
Publication Year :
2020
Publisher :
Public Library of Science (PLoS), 2020.

Abstract

IntroductionCoronavirus 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.MethodsThis 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).ResultsOverall, 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.ConclusionEarly adjunctive treatment with tocilizumab, methylprednisolone or both may improve outcomes in non-intubated patients with COVID-19 pneumonia.

Subjects

Subjects :
Medicine
Science

Details

Language :
English
ISSN :
19326203
Volume :
15
Issue :
8
Database :
Directory of Open Access Journals
Journal :
PLoS ONE
Publication Type :
Academic Journal
Accession number :
edsdoj.61e3552261414292b263d45357265e00
Document Type :
article
Full Text :
https://doi.org/10.1371/journal.pone.0237831