A study was conducted to evaluate the efficacy and safety of baricitinib, an oral selective Janus kinase 1/2 inhibitor, in combination with standard of care for the treatment of hospitalised patients with COVID-19.
A total of 1525 participants were enrolled from 101 centres across 12 countries in Asia, Europe, North America and South America. COVID-19 patients receiving standard of care were assigned to receive once-daily 4 mg baricitinib or placebo for up to 14 days. Standard of care included treatment with systemic corticosteroids (such as dexamethasone) and antivirals (including remdesivir).
The primary endpoint of the study was the proportion of patients who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation or death by day 28. The secondary endpoint included all-cause mortality by day 28. All-cause mortality by day 60 was an exploratory endpoint.
The findings of the study show that 27.8% of the participants who received baricitinib met the primary endpoint compared to 30.5% of the participants receiving placebo. The 28-day all-cause mortality was 8% for the baricitinib group and 13% for the placebo group, corresponding to a 38.2% reduction in mortality. One additional death was prevented per 20 baricitinib-treated participants.
The 60-day all-cause mortality was 10% for the baricitinib group and 15% for the placebo group. Serious adverse events occurred in 15% of participants in the baricitinib group compared to 18% in the placebo group. Serious infections and venous thromboembolic events were similar between both groups.
Overall, these findings show no significant reduction in the frequency of disease progression with the addition of baricitinib to standard of care. However, the addition of baricitinib with standard of care was associated with reduced mortality in hospitalised patients with COVID-19.
Source: The Lancet
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