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Comparative Survival Analysis of Immunomodulatory Therapy for Coronavirus Disease 2019 Cytokine Storm

Authors
  • Narain, Sonali1, 2
  • Stefanov, Dimitre G.3, 4
  • Chau, Alice S.5
  • Weber, Andrew G.6
  • Marder, Galina1, 2
  • Kaplan, Blanka7, 2
  • Malhotra, Prashant2, 8
  • Bloom, Ona2, 9
  • Liu, Audrey10
  • Lesser, Martin L.2, 3, 4, 9
  • Hajizadeh, Negin2, 4, 6
  • Cohen, Stuart L.
  • Cookingham, Jennifer
  • Hirschwerk, David A.
  • Maria, Naomi I.
  • Satapathy, Sanjaya K.
  • Sison, Cristina
  • Taylor, Matthew
  • Qiu, Michael
  • 1 Division of Rheumatology, Department of Medicine, Northwell Health, Great Neck, NY
  • 2 Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, Hempstead, NY
  • 3 Biostatistics Unit, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY
  • 4 Institute of Health Innovations and Outcomes Research, The Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY
  • 5 Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington and Center for Immunity and Immunotherapies, Seattle Children’s Research Institute, Seattle, WA
  • 6 Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Northwell Health, Manhasset, NY
  • 7 Division of Allergy and Immunology, Department of Pediatrics, Northwell Health, Great Neck, NY
  • 8 Division of Infectious Diseases, Department of Medicine, Northwell Health, Manhasset, NY
  • 9 Institute of Molecular Medicine, The Feinstein Institutes for Medical Research, Manhasset, NY
  • 10 Department of Medicine, Northwell Health, Manhasset, NY
Type
Published Article
Journal
CHEST Journal
Publisher
Elsevier
Publication Date
Oct 17, 2020
Identifiers
DOI: 10.1016/j.chest.2020.09.275
PMID: 33075378
PMCID: PMC7567703
Source
PubMed Central
Keywords
License
Unknown

Abstract

Background Cytokine storm is a marker of coronavirus disease 2019 (COVID-19) illness severity and increased mortality. Immunomodulatory treatments have been repurposed to improve mortality outcomes. Research Question Do immunomodulatory therapies improve survival in patients with COVID-19 cytokine storm (CCS)? Study Design and Methods We conducted a retrospective analysis of electronic health records across the Northwell Health system. COVID-19 patients hospitalized between March 1, 2020, and April 24, 2020, were included. CCS was defined by inflammatory markers: ferritin, > 700 ng/mL; C-reactive protein (CRP), > 30 mg/dL; or lactate dehydrogenase (LDH), > 300 U/L. Patients were subdivided into six groups: no immunomodulatory treatment (standard of care) and five groups that received either corticosteroids, anti-IL-6 antibody (tocilizumab), or anti-IL-1 therapy (anakinra) alone or in combination with corticosteroids. The primary outcome was hospital mortality. Results Five thousand seven hundred seventy-six patients met the inclusion criteria. The most common comorbidities were hypertension (44%-59%), diabetes (32%-46%), and cardiovascular disease (5%-14%). Patients most frequently met criteria with high LDH (76.2%) alone or in combination, followed by ferritin (63.2%) and CRP (8.4%). More than 80% of patients showed an elevated D-dimer. Patients treated with corticosteroids and tocilizumab combination showed lower mortality compared with patients receiving standard-of-care (SoC) treatment (hazard ratio [HR], 0.44; 95% CI, 0.35-0.55; P  < .0001) and with patients treated with corticosteroids alone (HR, 0.66; 95% CI, 0.53-0.83; P  = .004) or in combination with anakinra (HR, 0.64; 95% CI, 0.50-0.81; P  = .003). Corticosteroids when administered alone (HR, 0.66; 95% CI, 0.57-0.76; P  < .0001) or in combination with tocilizumab (HR, 0.43; 95% CI, 0.35-0.55; P  < .0001) or anakinra (HR, 0.68; 95% CI, 0.57-0.81; P  < .0001) improved hospital survival compared with SoC treatment. Interpretation The combination of corticosteroids with tocilizumab showed superior survival outcome when compared with SoC treatment and treatment with corticosteroids alone or in combination with anakinra. Furthermore, corticosteroid use either alone or in combination with tocilizumab or anakinra was associated with reduced hospital mortality for patients with CCS compared with patients receiving SoC treatment.

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