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

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New data from a phase 3 COV-BARRIER substudy indicate that one death was avoided for six COVID-19 patients treated with baricitinib under mechanical ventilation or extracorporeal membrane oxygenation (ECMO) compared to placebo.

Eli Lilly and Company (Indianapolis, Ind, USA) announced the results of an additional cohort of 101 adult patients in the VOC-BARRIER trial of baricitinib, a JAK1 / JAK2 inhibitor licensed to the company by Incyte (Wilmington, DE, USA). In this substudy, mechanically ventilated or ECMO COVID-19 patients who received baricitinib plus standard of care were 46% less likely to die on day 28 compared to patients who received placebo plus standard. of care. The cumulative proportion of patients who died on day 28 was 39.2% in the baricitinib arm versus 58% in the placebo arm. A similar mortality benefit was observed at day 60 with a cumulative proportion of deaths of 45.1% for baricitinib versus 62% for placebo. These results were consistent with the reduction in mortality observed in the overall VOC-BARRIER patient population.

On day 28, the frequency of adverse events, serious adverse events and serious infections was 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 signal has been identified. Lilly intends to publish the detailed results of this additional sub-study in a peer-reviewed journal and present the results at a medical meeting in the coming months. This new data from the COV-BARRIER substudy will also be shared with regulators in the United States, the European Union and other geographies.

“As more data from COV-BARRIER becomes available, it is increasingly clear that treatment with baricitinib may help prevent death in some of the most seriously ill COVID-19 patients and that baricitinib is an option important treatment for this vulnerable group of patients in this evolving pandemic, ”said E. Wesley Ely, MD, MPH, professor of medicine and co-director of the Center for Critical Illness, Brain Dysfunction and Survival (CIBS) at Vanderbilt University Medical Center and COV-BARRIER Co-Principal Investigator.

“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 can help improve outcomes for patients with severe disease. critical illness, ”said Ilya Yuffa, senior vice president and president of Lilly. Bio-Medicine. “These new data add to the growing body of evidence demonstrating the important role that baricitinib has and may continue to play for some hospital patients with COVID-19. “

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Eli Lilly and company
Incyte


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