Emergency Use Approved for Baricitinib with Remdesivir Combination Therapy for SARS-CoV-2

On Nov. 19, the U.S. Food & Drug Administration issued an emergency use authorization for a combination therapy of baricitinib and remdesivir to treat suspected or laboratory-confirmed cases of COVID-19 in hospitalized patients. Eligible patients must be aged 2 years or older and require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.¹

This emergency use authorization is based on a double-blind, randomized, placebo-controlled, clinical trial, ACTT-2, conducted by the National Institute of Allergy and Infectious Diseases. In the study, hospitalized patients who received remdesivir with baricitinib experienced a reduced time to recovery compared with patients who received only remdesivir.

The clinical trial tracked patients (N=1,033) with moderate or severe COVID-19 for 29 days. Patients received either the combination therapy of baricitinib and remdesivir (n=515) or remdesivir monotherapy with placebo (n=518). Recovery was defined as either the patient being discharged from the hospital or being hospitalized without supplemental oxygen and not requiring ongoing medical care.

Results
The median COVID-19 recovery time for the combination therapy was seven days, and the median COVID-19 recovery time for remdesivir plus placebo was eight days. The odds of the disease worsening with a progression toward death or being ventilated at day 29 was lower in patients taking the combination therapy than in patients taking remdesivir monotherapy. The odds of achieving clinical improvement at day 15 were also higher for the combination therapy group than the monotherapy group. All study endpoint effects were statistically significant.

Potential adverse events of the baricitinib and remdesivir combination therapy include serious infections, thrombosis, allergic reactions, aminotransferase elevations and other lab abnormalities. The efficacy and safety of this combination have not been evaluated. Baricitinib should not be used as monotherapy treatment for COVID-19.

To determine treatment suitability and dose at baseline, clinicians should evaluate patients’ eGFR, liver enzymes and complete blood count.² Baricitinib must be dose adjusted for an eGFR level of less than 60 mL/min/1.73m². The baricitinib dose should be stopped if the patient’s absolute leukocyte count drops below 200 cells/µL or the absolute neutrophil count drops below 500 cells/µL. Patients should be closely monitored during treatment for abnormal post-baseline laboratory values.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. U.S. Food & Drug Administration. News release: Coronavirus (COVID-19) update: FDA authorizes drug combination for treatment of COVID-19. 2020 Nov 19.
2. U.S. Food & Drug Administration. Fact sheet for healthcare providers emergency use authorization (EUA) of baricitinib. 2020 Nov.