Baricitinib Does Not Meet Primary Endpoint in Phase 3 COV-BARRIER Study

Today, Eli Lilly and Company and Incyte announced results from their COV-BARRIER study, indicating that baricitinib did not show a statistically significant benefit on the primary endpoint.

However, treatment with baricitinib, in addition to standard of care, resulted in a significant reduction in death from any cause by 38%.

"Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies," Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines said. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19.”

The COV-BARRIER study, a phase 3 trial evaluating baricitinib 4 mg once daily plus standard of care versus placebo plus standard of care, is the first global, randomized, double-blind, placebo controlled study assessing the therapy in patients hospitalized with COVID-19.

The primary endpoint of the study 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.

The study included 1,525 patients and began in June of 2020. All participants were treated with standard of care which could have included corticosteroids, antimalarials, antivirals, and/or azithromycin. They were randomized 1:1 to receive either 4 mg of baricitinib or a placebo for up to 14 days or until discharge from the hospital.

Findings showed that the patients who received baricitinib in combination with remdesivir had a shorter median time to recovery compared to patients who received remdesivir alone.

Additionally, results from the NIAID's ACTT-2 study showed that there was a significant reduction in the proportion of patients progressing to noninvasive ventilation, invasive mechanical ventilation or death. A numerical decrease in mortality risk through Day 29 was also observed in patients treated with baricitinib plus remdesivir.

"While the trend observed for the primary endpoint was not significant, the demonstration of a potential effect on mortality is a clinically important finding. This effect on mortality was seen with or without corticosteroids and/or remdesivir at the time of enrollment," Vincent C. Marconi, a co-principal investigator of on the COV-BARRIER study said. "These results – along with those from the NIAID-sponsored ACTT-2 study evaluating baricitinib in combination with remdesivir – add to the growing body of data supporting the use of baricitinib in certain hospitalized patients with COVID-19."