Tocilizumab in COVID-19 interstitial pneumonia.
Aged
Antibodies, Monoclonal, Humanized
/ administration & dosage
Biomarkers, Pharmacological
/ analysis
COVID-19
/ diagnosis
Drug Monitoring
/ methods
Female
Humans
Immunologic Factors
/ administration & dosage
Infusions, Intravenous
Interleukin-6
/ antagonists & inhibitors
Italy
/ epidemiology
Male
Oximetry
/ methods
Oxygen Inhalation Therapy
/ methods
Pneumonia, Viral
/ drug therapy
Predictive Value of Tests
Respiratory Function Tests
/ methods
SARS-CoV-2
/ isolation & purification
Treatment Outcome
COVID-19
IL-6
pneumonia
severe acute respiratory syndrome
tocilizumab
Journal
Journal of internal medicine
ISSN: 1365-2796
Titre abrégé: J Intern Med
Pays: England
ID NLM: 8904841
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
revised:
25
11
2020
received:
23
09
2020
accepted:
14
12
2020
pubmed:
30
1
2021
medline:
5
5
2021
entrez:
29
1
2021
Statut:
ppublish
Résumé
Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues. This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response. Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response. Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.
Sections du résumé
BACKGROUND
Published reports on tocilizumab in COVID-19 pneumonitis show conflicting results due to weak designs or heterogeneity in critical methodological issues.
METHODS
This open-label trial, structured according to Simon's optimal design, aims to identify factors predicting which patients could benefit from anti-IL6 strategies and to enhance the design of unequivocal and reliable future randomized trials. A total of 46 patients with COVID-19 pneumonia needing of oxygen therapy to maintain SO2 > 93% and with recent worsening of lung function received a single infusion of tocilizumab. Clinical and biological markers were measured to test their predictive values. Primary end point was early and sustained clinical response.
RESULTS
Twenty-one patients fulfilled pre-defined response criteria. Lower levels of IL-6 at 24 h after tocilizumab infusion (P = 0.049) and higher baseline values of PaO2/FiO2 (P = 0.008) predicted a favourable response.
CONCLUSIONS
Objective clinical response rate overcame the pre-defined threshold of 30%. Efficacy of tocilizumab to improve respiratory function in patients selected according to our inclusion criteria warrants investigations in randomized trials.
Identifiants
pubmed: 33511686
doi: 10.1111/joim.13231
pmc: PMC8013903
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Biomarkers, Pharmacological
0
Immunologic Factors
0
Interleukin-6
0
tocilizumab
I031V2H011
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
738-746Subventions
Organisme : Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona, Italy
Informations de copyright
© 2020 The Association for the Publication of the Journal of Internal Medicine.
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