Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients

Michael Sirimaturos; Deepa B. Gotur; Samir J. Patel; Diane Dreucean; Nicholas Jakowenko; Megan H. Cooper; Nishal Brahmbhatt; Edward A. Graviss; Duc T. Nguyen; Sai Ravi Pingali; Jiejian Lin; William L. Musick

doi:10.1097/CCE.0000000000000232

Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients

Michael Sirimaturos, Deepa B. Gotur, Samir J. Patel, Diane Dreucean, Nicholas Jakowenko, Megan H. Cooper, Nishal Brahmbhatt, Edward A. Graviss, Duc T. Nguyen, Sai Ravi Pingali, Jiejian Lin, William L. Musick

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8 Scopus citations

Abstract

UNLABELLED: Effective treatments for the critically ill patient with novel coronavirus disease 2019 are desperately needed. Given the role of cytokine release syndrome in the pathogenesis of coronavirus disease 2019-associated respiratory distress, therapies aimed at mitigating cytokine release, such as the interleukin-6 receptor-inhibiting monoclonal antibody tocilizumab, represent potential treatment strategies. Therefore, we examined the outcomes of critically ill coronavirus disease 2019 patients treated with tocilizumab and factors associated with clinical improvement.

DESIGN: A retrospective cohort analysis of 21-day outcomes for consecutive mechanically ventilated patients treated with tocilizumab from March 24, 2020, to May 4, 2020.

SETTING: Nine ICUs at six hospitals within a hospital system in Houston, Texas, United States.

PATIENTS: The first 62 coronavirus disease 2019 patients on invasive mechanical ventilation who were treated with tocilizumab, which was considered for all patients with severe disease.

INTERVENTIONS: Tocilizumab was administered either at a weight-based dose of 4-8 mg/kg or at a flat dose of 400 mg, with repeat administration in some patients at the physician's discretion.

MEASUREMENTS AND MAIN RESULTS: The primary outcomes were mortality and clinical improvement, defined as extubation. By day 21 post-tocilizumab, clinical improvement occurred in 36 patients (58%) and 13 patients (21%) died. In both univariable and multivariable analyses, age less than 60 years was associated with clinical improvement. Transient transaminitis was the most common adverse reaction, occurring in 25 patients (40%).

CONCLUSIONS: Based on clinical outcomes and mortality rates seen in previous reports of mechanically ventilated patients, tocilizumab, as part of the management strategy for severe coronavirus disease 2019, represents a promising option. These findings support the need for evaluation of tocilizumab in a randomized controlled trial.

Original language	English (US)
Pages (from-to)	E0232
Journal	Critical care explorations
Volume	2
Issue number	10
DOIs	https://doi.org/10.1097/CCE.0000000000000232
State	Published - Oct 2020

Keywords

anti-interleukin-6
cytokine release syndrome
respiratory distress syndrome, adult
severe acute respiratory syndrome coronavirus 2 infection

ASJC Scopus subject areas

Critical Care and Intensive Care Medicine

Divisions

Infectious Disease
Medical Oncology
Pulmonary, Critical Care and Sleep Medicine

Access to Document

10.1097/CCE.0000000000000232

Cite this

Sirimaturos, M., Gotur, D. B., Patel, S. J., Dreucean, D., Jakowenko, N., Cooper, M. H., Brahmbhatt, N., Graviss, E. A., Nguyen, D. T., Pingali, S. R., Lin, J., & Musick, W. L. (2020). Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients. Critical care explorations, 2(10), E0232. https://doi.org/10.1097/CCE.0000000000000232

Sirimaturos, M, Gotur, DB, Patel, SJ, Dreucean, D, Jakowenko, N, Cooper, MH, Brahmbhatt, N, Graviss, EA, Nguyen, DT, Pingali, SR , Lin, J & Musick, WL 2020, 'Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients', Critical care explorations, vol. 2, no. 10, pp. E0232. https://doi.org/10.1097/CCE.0000000000000232

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title = "Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients",

abstract = "UNLABELLED: Effective treatments for the critically ill patient with novel coronavirus disease 2019 are desperately needed. Given the role of cytokine release syndrome in the pathogenesis of coronavirus disease 2019-associated respiratory distress, therapies aimed at mitigating cytokine release, such as the interleukin-6 receptor-inhibiting monoclonal antibody tocilizumab, represent potential treatment strategies. Therefore, we examined the outcomes of critically ill coronavirus disease 2019 patients treated with tocilizumab and factors associated with clinical improvement.DESIGN: A retrospective cohort analysis of 21-day outcomes for consecutive mechanically ventilated patients treated with tocilizumab from March 24, 2020, to May 4, 2020.SETTING: Nine ICUs at six hospitals within a hospital system in Houston, Texas, United States.PATIENTS: The first 62 coronavirus disease 2019 patients on invasive mechanical ventilation who were treated with tocilizumab, which was considered for all patients with severe disease.INTERVENTIONS: Tocilizumab was administered either at a weight-based dose of 4-8 mg/kg or at a flat dose of 400 mg, with repeat administration in some patients at the physician's discretion.MEASUREMENTS AND MAIN RESULTS: The primary outcomes were mortality and clinical improvement, defined as extubation. By day 21 post-tocilizumab, clinical improvement occurred in 36 patients (58\%) and 13 patients (21\%) died. In both univariable and multivariable analyses, age less than 60 years was associated with clinical improvement. Transient transaminitis was the most common adverse reaction, occurring in 25 patients (40\%).CONCLUSIONS: Based on clinical outcomes and mortality rates seen in previous reports of mechanically ventilated patients, tocilizumab, as part of the management strategy for severe coronavirus disease 2019, represents a promising option. These findings support the need for evaluation of tocilizumab in a randomized controlled trial.",

keywords = "anti-interleukin-6, cytokine release syndrome, respiratory distress syndrome, adult, severe acute respiratory syndrome coronavirus 2 infection",

author = "Michael Sirimaturos and Gotur, \{Deepa B.\} and Patel, \{Samir J.\} and Diane Dreucean and Nicholas Jakowenko and Cooper, \{Megan H.\} and Nishal Brahmbhatt and Graviss, \{Edward A.\} and Nguyen, \{Duc T.\} and Pingali, \{Sai Ravi\} and Jiejian Lin and Musick, \{William L.\}",

note = "Copyright {\textcopyright} 2020 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine.",

year = "2020",

month = oct,

doi = "10.1097/CCE.0000000000000232",

language = "English (US)",

volume = "2",

pages = "E0232",

journal = "Critical care explorations",

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publisher = "Lippincott Williams and Wilkins",

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TY - JOUR

T1 - Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients

AU - Sirimaturos, Michael

AU - Gotur, Deepa B.

AU - Patel, Samir J.

AU - Dreucean, Diane

AU - Jakowenko, Nicholas

AU - Cooper, Megan H.

AU - Brahmbhatt, Nishal

AU - Graviss, Edward A.

AU - Nguyen, Duc T.

AU - Pingali, Sai Ravi

AU - Lin, Jiejian

AU - Musick, William L.

PY - 2020/10

Y1 - 2020/10

N2 - UNLABELLED: Effective treatments for the critically ill patient with novel coronavirus disease 2019 are desperately needed. Given the role of cytokine release syndrome in the pathogenesis of coronavirus disease 2019-associated respiratory distress, therapies aimed at mitigating cytokine release, such as the interleukin-6 receptor-inhibiting monoclonal antibody tocilizumab, represent potential treatment strategies. Therefore, we examined the outcomes of critically ill coronavirus disease 2019 patients treated with tocilizumab and factors associated with clinical improvement.DESIGN: A retrospective cohort analysis of 21-day outcomes for consecutive mechanically ventilated patients treated with tocilizumab from March 24, 2020, to May 4, 2020.SETTING: Nine ICUs at six hospitals within a hospital system in Houston, Texas, United States.PATIENTS: The first 62 coronavirus disease 2019 patients on invasive mechanical ventilation who were treated with tocilizumab, which was considered for all patients with severe disease.INTERVENTIONS: Tocilizumab was administered either at a weight-based dose of 4-8 mg/kg or at a flat dose of 400 mg, with repeat administration in some patients at the physician's discretion.MEASUREMENTS AND MAIN RESULTS: The primary outcomes were mortality and clinical improvement, defined as extubation. By day 21 post-tocilizumab, clinical improvement occurred in 36 patients (58%) and 13 patients (21%) died. In both univariable and multivariable analyses, age less than 60 years was associated with clinical improvement. Transient transaminitis was the most common adverse reaction, occurring in 25 patients (40%).CONCLUSIONS: Based on clinical outcomes and mortality rates seen in previous reports of mechanically ventilated patients, tocilizumab, as part of the management strategy for severe coronavirus disease 2019, represents a promising option. These findings support the need for evaluation of tocilizumab in a randomized controlled trial.

AB - UNLABELLED: Effective treatments for the critically ill patient with novel coronavirus disease 2019 are desperately needed. Given the role of cytokine release syndrome in the pathogenesis of coronavirus disease 2019-associated respiratory distress, therapies aimed at mitigating cytokine release, such as the interleukin-6 receptor-inhibiting monoclonal antibody tocilizumab, represent potential treatment strategies. Therefore, we examined the outcomes of critically ill coronavirus disease 2019 patients treated with tocilizumab and factors associated with clinical improvement.DESIGN: A retrospective cohort analysis of 21-day outcomes for consecutive mechanically ventilated patients treated with tocilizumab from March 24, 2020, to May 4, 2020.SETTING: Nine ICUs at six hospitals within a hospital system in Houston, Texas, United States.PATIENTS: The first 62 coronavirus disease 2019 patients on invasive mechanical ventilation who were treated with tocilizumab, which was considered for all patients with severe disease.INTERVENTIONS: Tocilizumab was administered either at a weight-based dose of 4-8 mg/kg or at a flat dose of 400 mg, with repeat administration in some patients at the physician's discretion.MEASUREMENTS AND MAIN RESULTS: The primary outcomes were mortality and clinical improvement, defined as extubation. By day 21 post-tocilizumab, clinical improvement occurred in 36 patients (58%) and 13 patients (21%) died. In both univariable and multivariable analyses, age less than 60 years was associated with clinical improvement. Transient transaminitis was the most common adverse reaction, occurring in 25 patients (40%).CONCLUSIONS: Based on clinical outcomes and mortality rates seen in previous reports of mechanically ventilated patients, tocilizumab, as part of the management strategy for severe coronavirus disease 2019, represents a promising option. These findings support the need for evaluation of tocilizumab in a randomized controlled trial.

KW - anti-interleukin-6

KW - cytokine release syndrome

KW - respiratory distress syndrome, adult

KW - severe acute respiratory syndrome coronavirus 2 infection

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SN - 2639-8028

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JO - Critical care explorations

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ER -

Clinical Outcomes Following Tocilizumab Administration in Mechanically Ventilated Coronavirus Disease 2019 Patients

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