Eli Lilly and Incyte’s Baricitinib Reduces Deaths among COVID-19 Patients Receiving Invasive Mechanical Ventilation

New data from a Phase 3 COV-BARRIER sub-study indicates one death prevented for every six baricitinib-treated COVID-19 patients on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) as compared to placebo.

Eli Lilly and Company (Indianapolis, Ind, USA) has announced results from an additional cohort of 101 adult patients from the COV-BARRIER trial of baricitinib, a JAK1/JAK2 inhibitor licensed to the company from Incyte (Wilmington, DE, USA). In this sub-study, patients with COVID-19 on mechanical ventilation or ECMO who received baricitinib plus standard of care were 46% less likely to die by Day 28 compared to patients who received placebo plus standard of care. The cumulative proportion of patients who died by Day 28 was 39.2% in the baricitinib arm versus 58% in the placebo arm. Similar mortality benefit was observed by Day 60 with a cumulative proportion of death of 45.1% for baricitinib as compared to 62% for placebo. These findings were consistent with the reduction in mortality observed in the overall COV-BARRIER patient population.

By Day 28, the frequency of adverse events, serious adverse events and serious infections were similar in the baricitinib group (88%, 50% and 44%, respectively) compared to placebo (95.9%, 71.4% and 53.1%, respectively). Venous thromboembolic events were reported in 6% of patients treated with baricitinib and 6.1% of patients treated with placebo. No new safety signals were identified. Lilly intends to publish detailed results from this additional sub-study in a peer-reviewed journal and present the findings at a medical meeting in the coming months. These new data from the COV-BARRIER sub-study will also be shared with regulatory authorities in the US, European Union and other geographies.

"As additional data from COV-BARRIER 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, M.D., M.P.H., 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 COV-BARRIER.

"In the interest of public health and safety, it remains a priority to provide healthcare professionals with as much information as possible about treatment options that may help improve outcomes for patients with severe disease," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "These new data add to the growing body of evidence demonstrating the important role baricitinib has and may continue to play for certain hospitalized patients with COVID-19."

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