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The Food and Drug Administration (FDA) has authorized the use of baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age and older requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.
The revised Emergency Use Authorization (EUA) no longer requires baricitinib be used in combination with remdesivir (Veklury).
The update was based on data from the COV-BARRIER study (ClinicalTrials.gov Identifier: NCT04421027), which compared treatment with baricitinib 4mg once daily (n=764) with placebo (n=761) in hospitalized adults with confirmed SARS-CoV-2 infection; only 19% of patients received remdesivir.
Though not statistically significant, findings showed that the proportion of patients who died or progressed to noninvasive ventilation/high-flow or invasive mechanical ventilation (primary endpoint) was lower in the baricitinib arm compared with the placebo arm (27.8% vs 30.5%; odds ratio, 0.85 [95% CI, 0.67-1.08; P =.180]).
The proportion of patients who died by day 28 (key secondary endpoint) was 8.1% for baricitinib and 13.3% for placebo (estimated difference in day 28 probability of mortality, -4.9% [95% CI, -8.0, -1.9]; hazard ratio, 0.56 [95% CI, 0.41-0.77].
Under the terms and conditions of the EUA, the use of baricitinib in combination with remdesivir is not contraindicated, as the safety and efficacy of the combination continues to be supported by the new data. The revised healthcare provider fact sheet can be found here.
Baricitinib is currently marketed under the brand name Olumiant for the treatment of rheumatoid arthritis.
References
- Fact sheet for healthcare providers Emergency Use Authorization (EUA) of baricitinib. Accessed July 29, 2021. https://www.fda.gov/media/143823/download.
- Frequently asked questions on the Emergency Use Authorization of baricitinib for treatment of COVID-19. Accessed July 29, 2021. https://www.fda.gov/media/143825/download.
