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Efficacy of tocilizumab in patients with COVID-19 ARDS undergoing noninvasive ventilation.
Crit Care. 2020 09 29; 24(1):589.CC

Abstract

BACKGROUND

The severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is extremely variable, ranging from asymptomatic patients to those who develop severe acute respiratory distress syndrome (ARDS). As for now, there are still no really effective therapies for coronavirus disease 2019 (COVID-19). Some evidences suggest that tocilizumab (TCZ) may avoid the progression of severe COVID-19. The aim of this retrospective case-control study was to analyze the efficacy and safety of TCZ in patients with COVID-19 ARDS undergoing noninvasive mechanical ventilation (NIV).

METHODS

Seventy-nine consecutive patients with severe COVID-19 pneumonia and worsening acute respiratory failure (ARF) were admitted to the Pulmonology Unit of Azienda USL of Reggio Emilia-IRCCS. All patients were inflamed (elevated CRP and IL-6 levels) and received NIV at admission according to the presence of a pO2/FiO2 ratio ≤ 200 mmHg. The possibility of being treated with TCZ depended on the drug availability. The primary outcome was the in-hospital mortality rate. A secondary composite outcome of worsening was represented by the patients who died in the pulmonology unit or were intubated.

RESULTS

Out of 79 patients, 41 were treated with TCZ. Twenty-eight patients received intravenous (IV) TCZ and 13 patients received subcutaneous (SC) TCZ. In-hospital overall mortality rate was 38% (30/79 patients). The probabilities of dying and being intubated during the follow-up using Kaplan-Meier method were significantly lower in total patients treated with TCZ compared to those of patients not treated with TCZ (log-rank p value = 0.006 and 0.036, respectively). However, using Cox multivariate analyses adjusted for age and Charlson comorbidity index only the association with the reduced risk of being intubated or dying maintained the significance (HR 0.44, 95%CI 0.22-0.89, p = 0.022). Two patients treated with TCZ developed cavitating lung lesions during the follow-up.

CONCLUSIONS

This study shows that TCZ treatment may be effective in COVID-19 patients with severe respiratory impairment receiving NIV. More data on safety are required. Randomized controlled trials are needed to confirm these results.

Authors+Show Affiliations

Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy. francesco.menzella@ausl.re.it.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Division of Rheumatology, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy. University of Modena and Reggio Emilia, Modena, Italy.Infectious Disease Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Epidemiology Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL-IRCCS di Reggio Emilia, 42123, Reggio Emilia, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32993751

Citation

Menzella, Francesco, et al. "Efficacy of Tocilizumab in Patients With COVID-19 ARDS Undergoing Noninvasive Ventilation." Critical Care (London, England), vol. 24, no. 1, 2020, p. 589.
Menzella F, Fontana M, Salvarani C, et al. Efficacy of tocilizumab in patients with COVID-19 ARDS undergoing noninvasive ventilation. Crit Care. 2020;24(1):589.
Menzella, F., Fontana, M., Salvarani, C., Massari, M., Ruggiero, P., Scelfo, C., Barbieri, C., Castagnetti, C., Catellani, C., Gibellini, G., Falco, F., Ghidoni, G., Livrieri, F., Montanari, G., Casalini, E., Piro, R., Mancuso, P., Ghidorsi, L., & Facciolongo, N. (2020). Efficacy of tocilizumab in patients with COVID-19 ARDS undergoing noninvasive ventilation. Critical Care (London, England), 24(1), 589. https://doi.org/10.1186/s13054-020-03306-6
Menzella F, et al. Efficacy of Tocilizumab in Patients With COVID-19 ARDS Undergoing Noninvasive Ventilation. Crit Care. 2020 09 29;24(1):589. PubMed PMID: 32993751.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of tocilizumab in patients with COVID-19 ARDS undergoing noninvasive ventilation. AU - Menzella,Francesco, AU - Fontana,Matteo, AU - Salvarani,Carlo, AU - Massari,Marco, AU - Ruggiero,Patrizia, AU - Scelfo,Chiara, AU - Barbieri,Chiara, AU - Castagnetti,Claudia, AU - Catellani,Chiara, AU - Gibellini,Giorgia, AU - Falco,Francesco, AU - Ghidoni,Giulia, AU - Livrieri,Francesco, AU - Montanari,Gloria, AU - Casalini,Eleonora, AU - Piro,Roberto, AU - Mancuso,Pamela, AU - Ghidorsi,Luca, AU - Facciolongo,Nicola, Y1 - 2020/09/29/ PY - 2020/07/12/received PY - 2020/09/22/accepted PY - 2020/9/30/entrez PY - 2020/10/1/pubmed PY - 2020/10/9/medline KW - Acute respiratory distress syndrome KW - COVID-19 KW - Noninvasive ventilation KW - SARS-CoV-2 KW - Tocilizumab SP - 589 EP - 589 JF - Critical care (London, England) JO - Crit Care VL - 24 IS - 1 N2 - BACKGROUND: The severity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is extremely variable, ranging from asymptomatic patients to those who develop severe acute respiratory distress syndrome (ARDS). As for now, there are still no really effective therapies for coronavirus disease 2019 (COVID-19). Some evidences suggest that tocilizumab (TCZ) may avoid the progression of severe COVID-19. The aim of this retrospective case-control study was to analyze the efficacy and safety of TCZ in patients with COVID-19 ARDS undergoing noninvasive mechanical ventilation (NIV). METHODS: Seventy-nine consecutive patients with severe COVID-19 pneumonia and worsening acute respiratory failure (ARF) were admitted to the Pulmonology Unit of Azienda USL of Reggio Emilia-IRCCS. All patients were inflamed (elevated CRP and IL-6 levels) and received NIV at admission according to the presence of a pO2/FiO2 ratio ≤ 200 mmHg. The possibility of being treated with TCZ depended on the drug availability. The primary outcome was the in-hospital mortality rate. A secondary composite outcome of worsening was represented by the patients who died in the pulmonology unit or were intubated. RESULTS: Out of 79 patients, 41 were treated with TCZ. Twenty-eight patients received intravenous (IV) TCZ and 13 patients received subcutaneous (SC) TCZ. In-hospital overall mortality rate was 38% (30/79 patients). The probabilities of dying and being intubated during the follow-up using Kaplan-Meier method were significantly lower in total patients treated with TCZ compared to those of patients not treated with TCZ (log-rank p value = 0.006 and 0.036, respectively). However, using Cox multivariate analyses adjusted for age and Charlson comorbidity index only the association with the reduced risk of being intubated or dying maintained the significance (HR 0.44, 95%CI 0.22-0.89, p = 0.022). Two patients treated with TCZ developed cavitating lung lesions during the follow-up. CONCLUSIONS: This study shows that TCZ treatment may be effective in COVID-19 patients with severe respiratory impairment receiving NIV. More data on safety are required. Randomized controlled trials are needed to confirm these results. SN - 1466-609X UR - https://www.unboundmedicine.com/medline/citation/32993751/Efficacy_of_tocilizumab_in_patients_with_COVID_19_ARDS_undergoing_noninvasive_ventilation_ L2 - https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-03306-6 DB - PRIME DP - Unbound Medicine ER -