Press release
Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients
- Randomized, double-blind, placebo-controlled study of 1,525 patients did not meet statistical significance on primary endpoint (progression to non-invasive
About this update from Incyte Corporation
[{"type":"text","content":"- Randomized, double-blind, placebo-controlled study of 1,525 patients did not meet statistical significance on primary endpoint (progression to non-invasive ventilation or invasive mechanical ventilation or death)\n - Data showed 38% reduction in mortality by Day 28 (nominal p-value=0.0018) in patients treated with baricitinib in addition to standard of care, including corticosteroids and remdesivir\n\n\nINDIANAPOLIS, April 8, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800). \nIn COV-BARRIER, treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction (nominal p-value=0.0018) in death from any cause by 38 percent (n/N: 62/764 [8.1%] baricitinib, 100/761 [13.1%] placebo; hazard ratio [HR]: 0.57; 95% CI: 0.41, 0.78) by Day 28. A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients and was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065). A reduction in mortality was also seen for the pre-specified subgroups of patients being treated with or without corticosteroids at baseline. \n\"There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients,\" said co-primary investigator E. Wesley Ely, M.D., MPH, professor of medicine and co-director of the Critical Illnes...