Critically ill COVID-19 patients on a mechanical ventilator or extracorporeal membrane oxygenation (ECMO) lived more often when randomized to receive baricitinib. Doctors call this drug ‘bari,’ and receiving the pill once a day for up to 14 days yielded one of the largest a survival advantages seen yet in the COVID pandemic, according to a study published in The Lancet Respiratory Medicine.
It is the first randomized study of the drug in ventilated ICU patients, half of whom received the study drug while the other received placebo. It is also the very drug predicted most likely to benefit COVID-19 patients in a recent AI study to determine which drugs could likely be repurposed to treat COVID-19.
“This study found that among COVID patients who were already critically ill on a mechanical ventilator, adding baricitinib to usual care (steroids) saved lives,” said first author E. Wes Ely, MD, professor of Medicine and Critical Care at Vanderbilt University Medical Center and associate director of aging research at the Nashville VA GRECC.
“At 60 days, 62% of patients given placebo had died versus only 45% of those receiving bari. This means that for every 6 people treated with bari as opposed to the placebo, one additional life was saved,” he said.
Baricitinib is an oral, selective Janus kinase (JAK) 1,2 inhibitor used in the treatment of rheumatoid arthritis that has previously shown efficacy in studies of hospitalized adults with COVID-19, including the COV-BARRIER multinational trial with study patients enrolled from 101 sites in 12 countries.
In designing this investigation, Ely partnered with Vince Marconi, MD, professor of Infectious Diseases at Emory University. Marconi and colleagues had been interested in using JAK inhibitors for more than a decade to suppress inflammation in HIV. When the computer determined baricitinib was the prime suspect to save lives in COVID-19, it set the physician-scientists in motion with other collaborators at Eli Lilly and around the world.
“These data offer us a new tool in our armamentarium to help people live even if they are sick enough to require a breathing machine,” Ely said.
The study took place from Dec. 23, 2020-April 10, 2021, enrolling 101 participants with 51 receiving baricitinib plus standard of care and 50 receiving placebo plus standard of care.
Treatment with baricitinib significantly reduced all-cause mortality when compared with placebo as 29 of the 50 participants (58%) died in the placebo group versus 20 of the 51 participants (39%) in the baricitinib group.
“This was a fairly small study of 100 patients done alongside our large phase III study of 1,525 patients in which we found similar life-saving benefit for less sick hospitalized patients,” Ely said.
“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 in a recent BMJ article.
The COV-Barrier study was funded by Eli Lilly and Co., under license from Incyte Corp. As a result of this study, baricitinib is being made available free to low-to-middle income countries globally to aid in pandemic relief and in an effort to achieve equity in delivery of this life-saving therapy.
The Lancet Respiratory Medicine
Method of Research
Randomized controlled/clinical trial
Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial
Article Publication Date
EWE reports research grants from the US Centers for Disease Control and Prevention (CDC), NIH, and Veterans Affairs; and has served as an unpaid consultant for Eli Lilly and Company. AVR reports research grants from Eli Lilly and Company; and has served as a speaker or consultant for AbbVie, Eli Lilly and Company, Novartis, Pfizer, Roche, Sobi, and Union Chimique Belge. CEK, SdB, RL, MLBP, and SC are employees and shareholders of Eli Lilly and Company. JDG reports research support from Eli Lilly and Company, Regeneron Pharmaceuticals, and Gilead Sciences; grants from NIH, Biomedical Advanced Research and Development Authority (administered by Merck), and Eurofins Viracor; and has served as a speaker or consultant for Eli Lilly and Company, Gilead Sciences, and Mylan Pharmaceuticals. JFKS reports research grants from Eli Lilly and Company; and has served as a speaker or consultant for Eli Lilly and Company, Amgen, Novartis, Janssen, and NovoNordisk. VCM reports research grants from the CDC, Gilead Sciences, NIH, Veterans Affairs, and ViiV Healthcare; honoraria from Eli Lilly and Company; has served as an advisory board member for Eli Lilly and Company and Novartis; and has participated as a study section chair for the NIH.