But placebo-controlled trial shows lower all-cause mortality at 28 days and 60 days in patients receiving baricitinib plus standard of care
WEDNESDAY, Sept. 8, 2021 (HealthDay News) — For hospitalized adults with COVID-19, treatment with baricitinib in addition to standard of care does not reduce the frequency of disease progression overall, but it is associated with reduced mortality, according to a study published online Sept. 1 in The Lancet Respiratory Medicine.
Vincent C. Marconi, M.D., from Emory University School of Medicine in Atlanta, and colleagues conducted a phase 3, double-blind trial involving participants from 101 centers across 12 countries. Hospitalized adults with COVID-19 receiving standard of care were randomly assigned to once-daily baricitinib or matched placebo (764 and 761, respectively) for up to 14 days. The proportion of patients who progressed to high-flow oxygen, noninvasive ventilation, invasive mechanical ventilation, or death by 28 days was the composite primary end point.
The researchers found that 27.8 and 30.5 percent of participants receiving baricitinib and placebo, respectively, progressed to meet the primary end point (odds ratio, 0.85; 95 percent confidence interval, 0.67 to 1.08; P = 0.18). The 28-day all-cause mortality rate was 8 and 13 percent for baricitinib and placebo, respectively (hazard ratio, 0.57; 95 percent confidence interval, 0.41 to 0.78; nominal P = 0.0018); per 20 baricitinib-treated patients, one additional death was prevented. The 60-day all-cause mortality was 10 and 15 percent for baricitinib and placebo, respectively (hazard ratio, 0.62; 95 percent confidence interval, 0.47 to 0.83; P = 0.0050). The two groups had similar frequencies of serious adverse events, serious infections, and venous thromboembolic events.
“Baricitinib plus standard of care could be a treatment option to reduce overall deaths in the context of the global burden of mortality during the COVID-19 pandemic,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Eli Lilly and Company, which manufactures baricitinib and funded the study, under license from Incyte Corporation.
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