Baricitinib Demonstrates 46% Reduction in Mortality Risk for Critically Ill COVID-19 Patients in Phase 3 COV-BARRIER Substudy

On August 3, 2021, Eli Lilly and Company and Incyte jointly announced positive results from a subgroup analysis of the phase 3 COV-BARRIER clinical trial for its oral JAK inhibitor baricitinib. The trial demonstrated that, compared with placebo, baricitinib plus standard of care successfully prevented death in 1 out of every 6 hospitalized COVID-19 patients receiving invasive mechanical ventilation. Eli Lilly plans to publish the detailed results of this study in a peer-reviewed journal. These new data will also be shared with regulatory authorities in the United States, the European Union, and other regions.

This study demonstrated that among adult patients with COVID-19 receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO), at day 28, treatment with baricitinib plus standard of care reduced the risk of death by 46% compared with placebo plus standard of care (HR=0.54, 95% CI, 0.31–0.96). The cumulative mortality rate was 39.2% (20/51) in the baricitinib group and 58% (29/50) in the placebo group.

By day 60, a similar survival benefit was observed (HR=0.56; 96% CI, 0.33–0.97), representing a 44% reduction in the risk of death. The cumulative mortality was 45.1% (23/51) in the baricitinib group compared with 62.0% (31/50) in the placebo group. These results are consistent with the overall mortality reduction observed among all participants in the COV-BARRIER trial.

In terms of safety, through Day 28, the incidence of adverse events, serious adverse events, and serious infections reported in the baricitinib group (88%, 50%, and 44%, respectively) was similar to that in the placebo group (95.9%, 71.4%, and 53.1%, respectively). Venous thromboembolic events were reported in 6% of patients receiving baricitinib and 6.1% of patients receiving placebo. No new safety signals were identified.

Baricitinib is a JAK inhibitor that suppresses the patient's immune response. It is currently approved in over 70 countries/regions worldwide for the treatment of adult patients with moderately to severely active rheumatoid arthritis. A previous trial demonstrated that, compared with remdesivir monotherapy, the combination of remdesivir and baricitinib reduced the median time to recovery from 18 days to 10 days in hospitalized COVID-19 patients requiring supplemental high-flow oxygen or non-invasive mechanical ventilation. On July 28, 2021, the FDA expanded the Emergency Use Authorization (EUA) for this drug to permit its use as a monotherapy for the treatment of COVID-19.

Note: The original text has been abridged.

References:

[1] Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation. Retrieved August 3, 2021, from https://www.prnewswire.com/news-releases/lilly-and-incytes-baricitinib-reduced-deaths-among-patients-with-covid-19-receiving-invasive-mechanical-ventilation-301346651.html

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