In a new study from Vanderbilt University, researchers found hospitalized patients with COVID-19 who received the rheumatoid arthritis drug baricitinib, in combination with the standard of care including corticosteroids, died less often than those receiving only the standard of care.
Hospitalized patients with the SARS-CoV-2 infection (which causes COVID-19), often develop an intense hyperinflammatory state that can lead to dysfunction of multiple organs, including acute respiratory distress syndrome, septic shock and death.
Despite treatment advances with remdesivir, dexamethasone and tocilizumab, reducing mortality among hospitalized patients remains a crucial unmet need.
The study included 1,525 hospitalized patients on supplemental oxygen from 101 centers across 12 countries in Asia, Europe, North America and South America.
Patients were assigned to receive baricitinib vs. placebo once a day for up to 14 days in addition to the standard of care, which included the medications dexamethasone and remdesivir.
The team discovered that baricitinib reduces 28-day and 60-day mortality by 5% as compared to placebo.
The team says it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients.
This class of medications represents an important treatment advance for this vulnerable group of patients in the constantly evolving pandemic,” Ely said.
Baricitinib is an inhibitor of Janus kinases (JAK) 1 and 2, which calms down the immune system.
Huge computer analysis was done early in the pandemic, trying to figure out what drugs were the best to repurpose for COVID anti-viral effects. Anti-inflammatory effects are also important for sicker, hospitalized patients.
JAK inhibitors selectively hit signaling via the JAK receptors, blocking transduction pathways that lead to inflammation.
Drugs like baricitinib stop multiple pathways of the inflammatory cascade to hold down the inflammation that COVID would usually start.
The team says that the sicker patients were at the time of enrollment, the greater the reduction in mortality.
One surprising finding is that although the drug reduces death, some patients still progress in their severity of illness.
Baricitinib was identified in February 2020 as a potential intervention for the treatment of COVID-19.
The FDA granted Emergency Use Authorization (EUA) to the drug in November 2020, to be given in combination with the drug remdesivir, then amended the EUA later to allow baricitinib to be given with or without remdesivir.
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The study is published in The Lancet Respiratory Medicine. One author of the study is E. Wesley Ely, MD, MPH.
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