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Safety and efficacy of anti-il6-receptor tocilizumab use in severe and critical patients affected by coronavirus disease 2019: A comparative analysis.
J Infect. 2020 10; 81(4):e11-e17.JI

Abstract

BACKGROUND

As the novel SARS-CoV-2 pandemic occurred, no specific treatment was yet available. Inflammatory response secondary to viral infection might be the driver of severe diseases. We report the safety and efficacy (in terms of overall survival and hospital discharge) of the anti-IL6 tocilizumab (TCZ) in subjects with COVID-19.

METHODS

This retrospective, single-center analysis included all the patients consecutively admitted to our Hospital with severe or critical COVID-19 who started TCZ treatment from March 13th to April 03rd, 2020. A 1:2 matching to patients not treated with TCZ was performed according to age, sex, severity of disease, P/F, Charlson Comorbidity Index and length of time between symptoms onset and hospital admittance. Descriptive statistics and non-parametric tests to compare the groups were applied. Kaplan Meier probability curves and Cox regression models for survival, hospital discharge and orotracheal intubation were used.

RESULTS

Seventy-four patients treated with TCZ were matched with 148 matched controls. They were mainly males (81.5%), Caucasian (82.0%) and with a median age of 59 years. The majority (69.8%) showed critical stage COVID-19 disease. TCZ use was associated with a better overall survival (HR 0.499 [95% CI 0.262-0.952], p = 0.035) compared to controls but with a longer hospital stay (HR 1.658 [95% CI 1.088-2.524], p = 0.019) mainly due to biochemical, respiratory and infectious adverse events.

DISCUSSION

TCZ use resulted potentially effective on COVID-19 in terms of overall survival. Caution is warranted given the potential occurrence of adverse events.

FINANCIAL SUPPORT

Some of the tocilizumab doses used in the subjects included in this analysis were provided by the "Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia" (EudraCT Number: 2020-001110-38) supported by the Italian National Agency for Drugs (AIFA). No specific funding support was planned for study design, data collection and analysis and manuscript writing of this paper.

Authors+Show Affiliations

Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy. Electronic address: roberto.rossotti@ospedaleniguarda.it.Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy.Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy.Department of Anaesthesia and Critical Care, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.Department of Anaesthesia and Critical Care, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Department of Anaesthesia and Critical Care, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy.Emergency Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Emergency Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Internal Medicine Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Internal Medicine Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Healthcare Management Department, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Chemical-Clinical and Microbiological Analysis, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Chemical-Clinical and Microbiological Analysis, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; Department of Oncology and Oncohematology, University of Milan, Milan, Italy.Pneumology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Rheumatology Unit, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.Infectious Diseases Unit, ASST Grande Ospedale Metropolitano Niguarda, Piazza Ospedale Maggiore 3, 20162 Milan, Italy.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32652164

Citation

Rossotti, Roberto, et al. "Safety and Efficacy of Anti-il6-receptor Tocilizumab Use in Severe and Critical Patients Affected By Coronavirus Disease 2019: a Comparative Analysis." The Journal of Infection, vol. 81, no. 4, 2020, pp. e11-e17.
Rossotti R, Travi G, Ughi N, et al. Safety and efficacy of anti-il6-receptor tocilizumab use in severe and critical patients affected by coronavirus disease 2019: A comparative analysis. J Infect. 2020;81(4):e11-e17.
Rossotti, R., Travi, G., Ughi, N., Corradin, M., Baiguera, C., Fumagalli, R., Bottiroli, M., Mondino, M., Merli, M., Bellone, A., Basile, A., Ruggeri, R., Colombo, F., Moreno, M., Pastori, S., Perno, C. F., Tarsia, P., Epis, O. M., & Puoti, M. (2020). Safety and efficacy of anti-il6-receptor tocilizumab use in severe and critical patients affected by coronavirus disease 2019: A comparative analysis. The Journal of Infection, 81(4), e11-e17. https://doi.org/10.1016/j.jinf.2020.07.008
Rossotti R, et al. Safety and Efficacy of Anti-il6-receptor Tocilizumab Use in Severe and Critical Patients Affected By Coronavirus Disease 2019: a Comparative Analysis. J Infect. 2020;81(4):e11-e17. PubMed PMID: 32652164.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of anti-il6-receptor tocilizumab use in severe and critical patients affected by coronavirus disease 2019: A comparative analysis. AU - Rossotti,Roberto, AU - Travi,Giovanna, AU - Ughi,Nicola, AU - Corradin,Matteo, AU - Baiguera,Chiara, AU - Fumagalli,Roberto, AU - Bottiroli,Maurizio, AU - Mondino,Michele, AU - Merli,Marco, AU - Bellone,Andrea, AU - Basile,Andriano, AU - Ruggeri,Ruggero, AU - Colombo,Fabrizio, AU - Moreno,Mauro, AU - Pastori,Stefano, AU - Perno,Carlo Federico, AU - Tarsia,Paolo, AU - Epis,Oscar Massimiliano, AU - Puoti,Massimo, AU - ,, Y1 - 2020/07/08/ PY - 2020/05/12/received PY - 2020/06/27/revised PY - 2020/07/06/accepted PY - 2020/7/12/pubmed PY - 2020/10/6/medline PY - 2020/7/12/entrez KW - COVID-19 KW - IL-6 KW - Orotracheal tube KW - SARS-CoV2 KW - Tocilizumab SP - e11 EP - e17 JF - The Journal of infection JO - J Infect VL - 81 IS - 4 N2 - BACKGROUND: As the novel SARS-CoV-2 pandemic occurred, no specific treatment was yet available. Inflammatory response secondary to viral infection might be the driver of severe diseases. We report the safety and efficacy (in terms of overall survival and hospital discharge) of the anti-IL6 tocilizumab (TCZ) in subjects with COVID-19. METHODS: This retrospective, single-center analysis included all the patients consecutively admitted to our Hospital with severe or critical COVID-19 who started TCZ treatment from March 13th to April 03rd, 2020. A 1:2 matching to patients not treated with TCZ was performed according to age, sex, severity of disease, P/F, Charlson Comorbidity Index and length of time between symptoms onset and hospital admittance. Descriptive statistics and non-parametric tests to compare the groups were applied. Kaplan Meier probability curves and Cox regression models for survival, hospital discharge and orotracheal intubation were used. RESULTS: Seventy-four patients treated with TCZ were matched with 148 matched controls. They were mainly males (81.5%), Caucasian (82.0%) and with a median age of 59 years. The majority (69.8%) showed critical stage COVID-19 disease. TCZ use was associated with a better overall survival (HR 0.499 [95% CI 0.262-0.952], p = 0.035) compared to controls but with a longer hospital stay (HR 1.658 [95% CI 1.088-2.524], p = 0.019) mainly due to biochemical, respiratory and infectious adverse events. DISCUSSION: TCZ use resulted potentially effective on COVID-19 in terms of overall survival. Caution is warranted given the potential occurrence of adverse events. FINANCIAL SUPPORT: Some of the tocilizumab doses used in the subjects included in this analysis were provided by the "Multicenter study on the efficacy and tolerability of tocilizumab in the treatment of patients with COVID-19 pneumonia" (EudraCT Number: 2020-001110-38) supported by the Italian National Agency for Drugs (AIFA). No specific funding support was planned for study design, data collection and analysis and manuscript writing of this paper. SN - 1532-2742 UR - https://www.unboundmedicine.com/medline/citation/32652164/Safety_and_efficacy_of_anti_il6_receptor_tocilizumab_use_in_severe_and_critical_patients_affected_by_coronavirus_disease_2019:_A_comparative_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0163-4453(20)30467-9 DB - PRIME DP - Unbound Medicine ER -