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Eli Lilly and Company and Incyte have announced promising results that patients with COVID-19 on mechanical ventilation saw a reduction in deaths with the addition of baricitinib treatment.
Eli Lilly and Company and Incyte announced on Aug. 3, 2021that an additional cohort of 101 adult patients in a sub-study within a clinical trial showed a reduction in mortality when treated with baricitinib in addition to standard care. In the sub-study, patients with COVID-19 on mechanical ventilation (ECMO), who received baricitinib plus standard of care were 46% less likely to die by the 28th day, compared to patients who received placebo plus standard of care.
The study also showed that approximately 39.2% of patients who received baricitinib plus standard care died on day 28 versus 58% of patients who received placebo plus standard care. On day 60, 45.1% of patients who received baricitinib plus standard care died as compared to 62% of patients who received placebo plus standard care. The findings were consistent with the mortality reduction observed in the overall clinical trial (COV-BARRIER) patient population. The dosing involved 4 mg of baricitinib once daily.
Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal, the company stated in a press release. New data from the sub-study will be shared with regulatory authorities in the United States, European Union, and other countries.
FDA broadened the Emergency Use Authorization (EUA) for baricitinib on July 28, 2021, allowing for treatment with or without remdesivir. The EUA includes baricitinib for treatment of COVID-19 in hospitalized patients two years of age or older requiring supplemental oxygen or non-invasive or invasive ECMO.
"As additional data from [the] COV-BARRIER [sudy] become available, it is increasingly evident that treatment with baricitinib may help prevent death in some of the most critically ill COVID-19 patients and that baricitinib represents an important treatment option for this vulnerable group of patients in this constantly evolving pandemic," said E. Wesley Ely, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center and co-principal investigator of the COV-BARRIER study, in the press release.