Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study.
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antiviral Agents
/ adverse effects
Betacoronavirus
/ drug effects
COVID-19
Coronavirus Infections
/ blood
Female
Humans
Italy
/ epidemiology
Male
Middle Aged
Outcome and Process Assessment, Health Care
Oxygen Inhalation Therapy
/ methods
Pandemics
Pneumonia, Viral
/ blood
Receptors, Interleukin-6
/ antagonists & inhibitors
Respiratory Insufficiency
/ etiology
Retrospective Studies
SARS-CoV-2
COVID-19
Coronavirus
Efficacy
Interleukin-6
Italy
Safety
Tocilizumab
Journal
European journal of internal medicine
ISSN: 1879-0828
Titre abrégé: Eur J Intern Med
Pays: Netherlands
ID NLM: 9003220
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
received:
03
05
2020
revised:
06
05
2020
accepted:
07
05
2020
pubmed:
3
6
2020
medline:
19
6
2020
entrez:
3
6
2020
Statut:
ppublish
Résumé
Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up. 65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
Sections du résumé
BACKGROUND
Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy.
METHODS
We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28-day follow-up.
RESULTS
65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups.
CONCLUSIONS
At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
Identifiants
pubmed: 32482597
pii: S0953-6205(20)30199-0
doi: 10.1016/j.ejim.2020.05.021
pmc: PMC7242960
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antiviral Agents
0
Receptors, Interleukin-6
0
tocilizumab
I031V2H011
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
43-49Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest The authors declare no conflict of interest.
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