The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir.

The data supporting this EUA for baricitinib combined with remdesivir are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

In the study, the combination of baricitinib and remdesivir reduced median time to recovery in hospitalized COVID-19 patients from eight days to seven days. Patients who required high-flow oxygen or non-invasive ventilation during their hospitalization appeared to have had the largest benefit: their median time to recovery was shortened from 18 days to ten days. In addition, participants’ conditions at day 15 of the study (as measured by an eight-category ordinal scale which ranked the severity of their condition) was significantly improved when they received the two therapeutics combined. Recipients of the two treatments also had slightly fewer serious adverse effects.

## Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.

Dosage

Patients received remdesivir intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily on days 2 through 10 or until hospital discharge or death. Baricitinib was administered as a 4-mg daily dose (either orally [two 2-mg tablets] or through a nasogastric tube) for 14 days or until hospital discharge.

Baricitinib

Baricitinib is an oral Janus kinase (JAK) inhibitor that is selective for JAK1 and JAK2. It is being evaluated for the treatment of COVID-19 because it may prevent cellular immune activation and inflammation. Baricitinib is approved by the Food and Drug Administration (FDA) to treat moderate to severe rheumatoid arthritis.

Remdesivir

Remdesivir is an intravenous nucleotide prodrug of an adenosine analog. Remdesivir binds to the viral RNA-dependent RNA polymerase, inhibiting viral replication through premature termination of RNA transcription. Remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged >12 years and weighing >40 kg).

Source:

https://www.nejm.org/doi/full/10.1056/NEJMoa2031994

https://www.covid19treatmentguidelines.nih.gov/statement-on-baricitinib-eua/

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19