Outcomes and biomarker analyses among patients with COVID-19 treated with interleukin 6 (IL-6) receptor antagonist sarilumab at a single institution in Italy

J Immunother Cancer. 2020 Aug;8(2):e001089. doi: 10.1136/jitc-2020-001089.

Abstract

Background: The inflammatory pathology observed in severe COVID-19 disease caused by the 2019 novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is characterized by elevated serum levels of C reactive protein (CRP) and cytokines, including interferon gamma, interleukin 8 (IL-8), and interleukin 6 (IL-6). Initial reports from the outbreak in Italy, China and the USA have provided anecdotal evidence of improved outcomes with the administration of anti-IL-6 agents, and large-scale trials evaluating these therapies are ongoing.

Study description: In this retrospective case series, clinical outcomes and correlates of response to treatment with the IL-6 receptor antagonist sarilumab are described for 15 patients with COVID-19 from a single institution in Southern Italy. Among 10 patients whose symptoms improved after sarilumab treatment, rapid decreases in CRP levels corresponded with clinical improvement. Lower levels of IL-6 at baseline as well as lower neutrophil to lymphocyte ratio as compared with patients whose COVID-19 did not improve with treatment were associated with sarilumab-responsive disease.

Conclusions: This observation may reflect a possible clinical benefit regarding early intervention with IL-6-modulatory therapies for COVID-19 and that CRP could be a potential biomarker of response to treatment.

Keywords: case reports; immunomodulation; inflammation mediators.

MeSH terms

  • Aged
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Antiviral Agents / therapeutic use
  • Biomarkers, Pharmacological / blood*
  • COVID-19
  • COVID-19 Drug Treatment
  • Coronavirus Infections / complications
  • Coronavirus Infections / diagnostic imaging
  • Coronavirus Infections / drug therapy*
  • Female
  • Humans
  • Interleukin-6 / blood*
  • Italy
  • Lymphocyte Count
  • Male
  • Middle Aged
  • Neutrophils
  • Pandemics
  • Pneumonia, Viral / complications
  • Pneumonia, Viral / diagnostic imaging
  • Pneumonia, Viral / drug therapy*
  • Receptors, Interleukin-6 / antagonists & inhibitors
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Biomarkers, Pharmacological
  • IL6 protein, human
  • IL6R protein, human
  • Interleukin-6
  • Receptors, Interleukin-6
  • sarilumab