Clinical Predictors of Response to Tocilizumab: A Retrospective Multicenter Study

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Abstract

OBJECTIVE:

A substantial number of patients with coronavirus disease-2019 (COVID-19) demonstrate severe infection. Cytokine storm is an underlying condition that worsens clinical outcomes. As an interleukin-6 receptor antagonist, tocilizumab is a promising treatment option for COVID-19. This study aimed to evaluate the clinical predictors of mortality for critically ill COVID-19 patients receiving tocilizumab therapy.

MATERIAL AND METHODS:

The retrospective cohort study was conducted in 4 centers’ both wards and intensive care units between March 20 and May 20, 2020. Demographic, clinical, and laboratory data were consecutively drawn from medical records. The primary endpoint was in-hospital mortality.

Results:

In this study, 39 patients (28.2% female) were included, and the mortality rate was 25.6% (n = 10). There was statistically significant difference between survivor and non-survivor groups regarding age (53.0 (46.5-65.0) vs. 75.0 (68.25-81.25), respectively, P = .001), CALL score (8.0 (7.0-10.0) vs. 12.0 (9.75-13.0), P = .001), GRAM score (119.5 (99.5-142.0) vs. 155.0 (129.8-226.0), P = .004), and white blood cell count (k/mL) (5.6 (3.8-8.6) vs. 8.0 (7.6-9.3), P = .003). The patients who were on invasive mechanical ventilation at the time of tocilizumab administration had a higher mortality rate (100% vs. 25.9%, P < .001). Besides, arterial partial pressure of oxygen/fraction of inspiratory oxygen (PaO ₂/FiO ₂) ratio on day 7, but not on days 0, 1, and 3 of tocilizumab therapy, was associated with mortality. C-reactive protein (mg/dL) tended to be lower in the survivor group; however, it was not statistically significant (68.4 (32.7-157.5) vs. 113.5 (77.7-219.0), P = .058).

Conclusion:

This study demonstrated that advanced age, increased leukocyte count, higher CALL and GRAM scores, and the need for invasive mechanical ventilation revealed a worse prognosis after tocilizumab treatment.

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Most cited references 23

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The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak

Hussin A Rothan, Siddappa Byrareddy (2020)

Coronavirus disease (COVID-19) is caused by SARS-COV2 and represents the causative agent of a potentially fatal disease that is of great global public health concern. Based on the large number of infected people that were exposed to the wet animal market in Wuhan City, China, it is suggested that this is likely the zoonotic origin of COVID-19. Person-to-person transmission of COVID-19 infection led to the isolation of patients that were subsequently administered a variety of treatments. Extensive measures to reduce person-to-person transmission of COVID-19 have been implemented to control the current outbreak. Special attention and efforts to protect or reduce transmission should be applied in susceptible populations including children, health care providers, and elderly people. In this review, we highlights the symptoms, epidemiology, transmission, pathogenesis, phylogenetic analysis and future directions to control the spread of this fatal disease.

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Development and Validation of a Clinical Risk Score to Predict the Occurrence of Critical Illness in Hospitalized Patients With COVID-19

Wenhua Liang, Hengrui Liang, Limin Ou … (2020)

Early identification of patients with novel coronavirus disease 2019 (COVID-19) who may develop critical illness is of great importance and may aid in delivering proper treatment and optimizing use of resources.

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Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia

Ivan Rosas, Norbert Bräu, Michael F. Waters … (2021)

Abstract Background Coronavirus disease 2019 (Covid-19) is associated with immune dysregulation and hyperinflammation, including elevated interleukin-6 levels. The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia in case reports and retrospective observational cohort studies. Data are needed from randomized, placebo-controlled trials. Methods In this phase 3 trial, we randomly assigned patients who were hospitalized with severe Covid-19 pneumonia in a 2:1 ratio receive a single intravenous infusion of tocilizumab (at a dose of 8 mg per kilogram of body weight) or placebo. Approximately one quarter of the participants received a second dose of tocilizumab or placebo 8 to 24 hours after the first dose. The primary outcome was clinical status at day 28 on an ordinal scale ranging from 1 (discharged or ready for discharge) to 7 (death) in the modified intention-to-treat population, which included all the patients who had received at least one dose of tocilizumab or placebo. Results Of the 452 patients who underwent randomization, 438 (294 in the tocilizumab group and 144 in the placebo group) were included in the primary and secondary analyses. The median value for clinical status on the ordinal scale at day 28 was 1.0 (95% confidence interval [CI], 1.0 to 1.0) in the tocilizumab group and 2.0 (non-ICU hospitalization without supplemental oxygen) (95% CI, 1.0 to 4.0) in the placebo group (between-group difference, −1.0; 95% CI, −2.5 to 0; P=0.31 by the van Elteren test). In the safety population, serious adverse events occurred in 103 of 295 patients (34.9%) in the tocilizumab group and in 55 of 143 patients (38.5%) in the placebo group. Mortality at day 28 was 19.7% in the tocilizumab group and 19.4% in the placebo group (weighted difference, 0.3 percentage points (95% CI, –7.6 to 8.2; nominal P=0.94). Conclusions In this randomized trial involving hospitalized patients with severe Covid-19 pneumonia, the use of tocilizumab did not result in significantly better clinical status or lower mortality than placebo at 28 days. (Funded by F. Hoffmann–La Roche and the Department of Health and Human Services; COVACTA ClinicalTrials.gov number, NCT04320615.)

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Author and article information

Journal

Journal ID (nlm-ta): Turk Thorac J

Journal ID (iso-abbrev): Turk Thorac J

Title: Turkish Thoracic Journal

Publisher: Turkish Thoracic Society

ISSN (Print): 2148-7197

ISSN (Electronic): 2149-2530

Publication date Collection: May 2022

Publication date (Electronic): 01 May 2022

Volume: 23

Issue: 3

Pages: 225-230

Affiliations

[1 ]Department of Pulmonology Medicine , Faculty of Medicine, Dokuz Eylül University, İzmir, Turkey

[2 ]Department of Pulmonology Medicine , Faculty of Medicine, Ege University, İzmir, Turkey

[3 ]Department of Pulmonology Medicine , Faculty of Medicine, Atatürk University, Erzurum, Turkey

[4 ]Department of Pulmonary Medicine , Florence Nightingale Hospital, İstanbul, Turkey

Author notes

Corresponding author: Selin Ercan, e-mail: selin.ercan@ 123456deu.edu.tr

Cite this article as: Ercan S, Ergan B, Özuygur SS, et al. Clinical predictors of response to tocilizumab: A retrospective multicenter study. Turk Thorac J. 2022; 23(3): 225-230.