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Nature Medicine publishes phase III anakinra study results in patients with COVID-19 pneumonia.- Swedish Orphan Biovitrium (SOBI)

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Published:4th Sep 2021
Swedish Orphan Biovitrum AB (publ) (Sobi) and the Hellenic Institute for the Study of Sepsis announce that Nature Medicine has published positive results from the investigator-sponsored phase III SAVE-MORE study evaluating anakinra plus standard of care (SOC) in patients with moderate-to-severe COVID-19 pneumonia

The study demonstrated that early and targeted use of anakinra, in addition to current SOC, reduces risk of death, reduces ICU admission and increases likelihood of full recovery in hospitalised COVID-19 patients with poor prognosis due to risk of severe respiratory failure (SRF).

KEY HIGHLIGHTS : i. Early treatment with anakinra showed considerable efficacy and reduced risk of disease progression and death by 64 percent, according to day 28 results from the SAVE-MORE study. ii. Relative decrease of mortality was 55%, reaching 80% for patients with cytokine storm. iii. Proportion of patients who fully recovered exceeded 50 percent, and number of patients remaining with severe disease reduced by 54 percent. Average time until hospital and intensive care unit (ICU) discharge was reduced by one and four days.

The SAVE-MORE study, conducted by the Hellenic Institute for the Study of Sepsis , is the first large, pivotal randomised controlled trial to specifically evaluate a patient population at risk of progressing to critical state and demonstrate considerable benefit of earlier intervention for the prevention of disease progression and death. Co-administered treatments were similar between the two arms of the study and included dexamethasone, anticoagulants and remdesivir. The study results were previously reported in May.

The results published in Nature Medicine provide the only data available on prevention from early stage progressing to critical status, indicating that the inflammatory disease needs to be treated earlier with a specifically targeted approach to IL-1 alpha and IL-1?,” 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.

See- Published: 03 September 2021."Early treatment of COVID-19 with anakinra guided by soluble urokinase plasminogen receptor plasma levels: a double-blind, randomized controlled phase III trial".: Evdoxia Kyriazopoulou, Garyfallia Poulakou, […]Evangelos J. Giamarellos-Bourboulis Nature Medicine (2021)-Nat Med (2021).

Condition: Coronavirus/Pneumonia
Type: drug

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