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The JAK1/2 inhibitor ruxolitinib in patients with COVID-19 triggered hyperinflammation: the RuxCoFlam trial

J Hammersen1, S Birndt1, K Döhner2

  • 1Universitätsklinikum Jena, Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie, Jena, Germany.

Leukemia
|July 28, 2023
PubMed

Insights

Ruxolitinib effectively reduced hyperinflammation in severe COVID-19 patients, as measured by the COVID-19 Inflammation Score (CIS). This Janus Kinase 1/2 inhibitor demonstrated safety and efficacy in a Phase II trial.

Area of Science:

  • Immunology
  • Virology
  • Pharmacology

Background:

  • Severe COVID-19 pathogenesis involves a dysregulated hyperinflammatory response, leading to acute respiratory distress syndrome and multiorgan failure.
  • Immunosuppression is effective, but optimal biological targets and treatment timing remain debated.

Purpose of the Study:

  • To evaluate the efficacy and safety of ruxolitinib, a Janus Kinase 1/2 inhibitor, in managing hyperinflammation in severe COVID-19 patients.
  • To assess ruxolitinib's impact using the COVID-19 Inflammation Score (CIS) in a prospective multicenter open-label Phase II trial (NCT04338958).

Main Methods:

  • 184 patients with a CIS ≥10 received ruxolitinib (10 mg twice daily) for a median of 14 days.
  • The primary objective was a ≥25% reduction in CIS at day 7 in at least 20% of patients.
  • Safety was assessed through adverse events, and efficacy was measured by CIS reduction and inflammatory markers.

Main Results:

  • 71% of patients achieved a ≥25% CIS reduction by day 7, indicating a significant decrease in hyperinflammation.
  • Median CIS decreased from 12 to 6, accompanied by reduced inflammatory markers.
  • Ruxolitinib was well-tolerated, with no grade 3-5 adverse events related to the drug. 23.9% of patients died, unrelated to the study drug.

Conclusions:

  • Ruxolitinib is a safe and effective treatment for hyperinflammation in severe COVID-19 patients.
  • The study supports ruxolitinib as a potential therapeutic option for managing COVID-19-associated hyperinflammatory states.
  • Targeting Janus Kinase 1/2 with ruxolitinib offers a promising strategy in severe COVID-19 treatment.

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