Early use of anakinra reduces risk of mortality for patients with COVID-19 pneumonia, reduces ICU admission and increases likelihood of full recovery.- Swedish Orphan Biovitrum

Swedish Orphan Biovitrum AB (publ) (Sobi) and the Hellenic Institute for the Study of Sepsis today announced positive day 28 full results from the investigator-sponsored SAVE-MORE study. SAVE-MORE found that early and targeted use of anakinra, in addition to current SOC, showed a 55% relative reduction in mortality and near threefold benefit in preventing progression to severe respiratory failure (SRF) in hospitalised COVID-19 patients with poor prognosis. Anakinra treatment also increased the number of patients discharged from hospital with no evidence of COVID-19 infection, with patients being 2.8 times more likely to fully recover than patients who received placebo and SOC. Results from the study, which included over 600 patients, were released on MedRxiv and have been submitted for peer-reviewed publication. SAVE-MORE is the first study to specifically evaluate COVID-19 patients at risk of SRF prior to ICU admission with the objectives of preventing disease progression or death and enhancing disease resolution. The trial assessed patients with moderate or severe pneumonia and specifically identified those at risk of SRF by the measurement of elevated suPAR (soluble urokinase plasminogen activator receptor), a plasma biomarker and prognostic tool that reflects early immune activation and has been previously associated with poor prognosis in various conditions. Co-administered treatments were similar between the two arms and included dexamethasone, anticoagulants and remdesivir. COVID-19 infection can be severe and lead to death due to an overreaction of the infected person’s inflammatory response, often referred to as a “cytokine storm”. Anakinra is an anti-inflammatory drug that targets the cytokines IL-1alpha/beta, which play an important role in COVID-19-induced hyperinflammation. Blocking IL-1alpha/beta at an early stage of disease can have an important impact on COVID-19 disease progression. To date, no drug has been approved for the treatment of the COVID-19 inflammatory response. “With excessive inflammatory response to COVID-19 infection being a leading cause of disease progression and mortality, there is an urgent need for medications that can target this hyperinflammation and prevent its evolution. The SAVE-MORE trial confirms a significant reduction in COVID deaths of 55% and also the prevention of severe respiratory failure and ICU admission in at risk patients with COVID related pneumonia, when treated early with anakinra and standard of care versus standard of care alone. The results show that the risk of critical illness can be reduced through early treatment,” said lead investigator Evangelos J. Giamarellos-Bourboulis, Professor of Internal Medicine and Infectious Diseases, National and Kapodistrian University of Athens, President of the European Shock Society, and Chairman of the European Sepsis Alliance. Analysis of the primary end point, the comparative 11-point WHO Clinical Progression Scale (CPS), measured patient illness by tracking progress through the healthcare system. At day 28, overall clinical status improved significantly in patients with severe COVID pneumonia likely to progress to SRF receiving SOC plus anakinra vs patients receiving SOC plus placebo (Odds Ratio 0.36, p<0.0001). for the same group of anakinra treated patients there were reductions in the number of patients who progressed to srf or death (odds ratio 0.46, p><0.01), as well as an increase in the number of patients who were discharged from hospital with no evidence of covid-19 infection (odds ratio 0.36, p><0.0001). 28-day mortality was also 55% lower among patients allocated to soc and anakinra treatment. the positive changes to overall improvement and reduced progression to srf or death were apparent at day 14. in the save-more study, the incidence of serious treatment-emergent adverse events (teaes) was lower in patients treated with anakinra and soc than patients who received soc only. the incidence of non-serious teaes was similar in both treatment groups.>