Off-label use of tocilizumab for the treatment of SARS-CoV-2 pneumonia in Milan, Italy.

Autor: Morena V; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy., Milazzo L; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy. Electronic address: laura.milazzo@unimi.it., Oreni L; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Bestetti G; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Fossali T; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Bassoli C; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy., Torre A; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Cossu MV; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Minari C; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Ballone E; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Perotti A; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Mileto D; Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli Sacco, Milan, Italy., Niero F; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Merli S; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Foschi A; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Vimercati S; Clinical Pathology Laboratory, ASST Fatebenefratelli Sacco, Milan, Italy., Rizzardini G; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Sollima S; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Bradanini L; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy., Galimberti L; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Colombo R; Department of Anesthesiology and Intensive Care, ASST Fatebenefratelli Sacco, Luigi Sacco Hospital, Milan, Italy., Micheli V; Microbiology, Virology and Bioemergence Diagnostics, ASST Fatebenefratelli Sacco, Milan, Italy., Negri C; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Ridolfo AL; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Meroni L; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy., Galli M; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy., Antinori S; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy; Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy., Corbellino M; Department of Infectious Diseases, ASST Fatebenefratelli Sacco, Milan, Italy.
Jazyk: angličtina
Zdroj: European journal of internal medicine [Eur J Intern Med] 2020 Jun; Vol. 76, pp. 36-42. Date of Electronic Publication: 2020 May 21.
DOI: 10.1016/j.ejim.2020.05.011
Abstrakt: Background: Tocilizumab, a humanized monoclonal antibody, targets IL-6 receptors blocking downstream pro-inflammatory effects of IL-6. In preliminary reports it was suggested to be beneficial in patients with severe COVID-19.
Methods: In this open-label prospective study we describe clinical characteristics and outcome of 51 patients hospitalized with confirmed and severe COVID-19 pneumonia treated with tocilizumab intravenously. All patients had elevated IL-6 plasma level (>40 pg/mL) and oxygen saturation <93% in ambient air. Clinical outcomes, oxygen support, laboratory data and adverse events were collected over a follow-up of 30 days.
Results: Forty-five patients (88%) were on high-flow oxygen supplementation, six of whom with invasive ventilation. From baseline to day 7 after tocilizumab we observed a dramatic drop of body temperature and CRP value with a significant increase in lymphocyte count (p<0.001). Over a median follow-up time of 34 days from tocilizumab, 34 patients (67%) showed an improvement in their clinical severity class; 31 were discharged; 17 (33%) showed a worsening of their clinical status, of these 14 died (27%). The mortality rate was significantly associated with mechanical ventilation at baseline (83.3% vs 20% of patients on non-invasive oxygen support; p=0.0001). The most frequent side effects were an increase of hepatic enzymes (29%), thrombocytopenia (14%), and serious bacterial and fungal infections (27%).
Conclusion: Tocilizumab exerts a rapidly beneficial effect on fever and inflammatory markers, although no significant impact on the clinical outcome can be inferred by our results. Critically ill patients seem to have a high risk of serious infections with this drug.
Competing Interests: Declaration of Competing Interests None.
(Copyright © 2020 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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