Baricitinib is a janus kinase inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Baricitinib is FDA-approved (and sold under the brand name Olumiant) for the treatment of moderately to severely active rheumatoid arthritis.
November 19, 2020, the FDA issued an emergency use authorization (EUA) to use baricitinib, in combination with remdesivir (Veklury), 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).
However, baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
Baricitinib is a prescription oral tablet.
The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.
November 19, 2020 - Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19.
Baricitinib Clinical Trials
Clinical Trial NCT04401579: Adaptive COVID-19 Treatment Trial 2 (ACTT-2)
- ACTT-2 will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized.
- This Phase 3 trial followed patients for 29 days and included 1,033 patients with moderate or severe COVID-19; 515 patients received baricitinib plus remdesivir, and 518 patients received placebo plus remdesivir.
- Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was seven days for baricitinib plus remdesivir and eight days for placebo plus remdesivir.
- The odds of a patient’s condition progressing to death or being ventilated at day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group.
- The odds of clinical improvement at day 15 was higher in the baricitinib plus remdesivir group versus the placebo plus remdesivir group.
- For all of these endpoints, the effects were statistically significant.