Critically-ill patients with COVID-19 requiring respiratory support survived at a statistically higher rate when randomized to receive the anti-inflammatory drug baricitinib, according to a study published in The Lancet Respiratory Medicine.
Baricitinib is a repurposed drug, originally developed for rheumatoid arthritis, whose use for COVID-19 was pioneered by Emory investigators at the Atlanta Veterans Affairs Medical Center in 2020. Last year, the Food and Drug Administration issued an amended Emergency Use Authorization for baricitinib to be used alone in COVID-19; it was at first approved in combination with the antiviral drug remdesivir.
“There are so few options for critically-ill patients with COVID-19 that these findings are encouraging,” says senior author Vincent Marconi, MD, professor of medicine and global health at Emory University School of Medicine and Rollins School of Public Health. “We were able to show that this repurposed medication could substantially reduce 60-day mortality in this high-risk population.”
Marconi and colleagues conducted the study in 18 hospitals in the United States, including Grady Memorial Hospital and the Atlanta VAMC, along with hospitals in Argentina, Brazil and Mexico, from December 2020 to April 2021. It was sponsored by Eli Lilly and Company, the manufacturer of baricitinib.
As an exploratory effort conducted alongside the larger Lilly-sponsored COV-BARRIER study (more than 1,500 patients), this was a randomized study of baricitinib in 101 ventilated ICU patients, half of whom received the study drug while the other received placebo.
After 60 days, 62% of patients given placebo had died versus only 45% of those receiving baricitinib. One way to look at this is: for every six people treated with baricitinib as opposed to placebo, one additional life was saved.
Baricitinib has been tested in several clinical trials previously, but this was the first to focus on critically ill patients. Participants in both arms received the standard of care, including in most cases (86%) another type of anti-inflammatory drug: corticosteroids.
“This study found that among COVID patients who were already critically ill on a mechanical ventilator, adding baricitinib to usual care (steroids) saved lives,” says first author E. Wes Ely, MD, MPH, professor of medicine and critical care at Vanderbilt University Medical Center. “Next, we need more clinical trials designed explicitly to determine how to improve survival for this subset of the world’s sickest COVID patients.”
The World Health Organization (WHO) recently updated its guidelines to “strongly recommend” baricitinib in combination with steroids to treat severe or critical COVID-19 patients.
Baricitinib is part of a class of drugs called JAK (Janus kinase) inhibitors. Marconi and colleagues at Emory have also investigated a related JAK inhibitor called ruxolitinib for treatment of HIV along with anti-retroviral drugs.