Put the EUA for Baricitinib Plus Remdesivir in Perspective

The oral rheumatoid arthritis med baricitinib (Olumiant) is now authorized to treat COVID-19 in hospitalized patients.

It's a Janus kinase (JAK) inhibitor that blocks cytokines to decrease inflammation. Plus it may have antiviral effects.

Explain that evidence suggests ADDING baricitinib to remdesivir (Veklury) reduces recovery time by 1 day...compared to remdesivir alone. But it's too soon to say if the combo reduces mortality.

Patients on a high-flow oxygen device...such as high-flow nasal cannula or BiPAP...seem to benefit the most.

Be aware, baricitinib's authorization requires remdesivir to be used with it. And it will cost $150/day...plus over $500/day for remdesivir.

The bigger issue is there aren't good data for using baricitinib with corticosteroids to treat COVID-19. And patients on supplemental oxygen will be on dexamethasone...the only med with mortality benefit.

Plus consider baricitinib's risks. For example, it can increase infection risk in patients with rheumatoid arthritis. Adding baricitinib to a steroid for COVID-19 may further increase this risk.

Baricitinib also has a boxed warning for VTE...which is already an issue with COVID-19. And the higher 4 mg baricitinib dose for COVID-19 isn't FDA-approved for rheumatoid arthritis...due to an increase in VTEs.

So far, baricitinib doesn't seem to significantly increase VTE in COVID-19 patients...but this is based on a small number of events. Point out that more data are needed to know the true risk.

Continue to start dexamethasone in COVID-19 patients requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Consider ADDING remdesivir...especially in those on low-flow oxygen.

Don't generally add baricitinib. But if it's used, follow emergency use authorization (EUA) criteria. For example, use VTE prophylaxis unless contraindicated...and adjust doses for eGFR under 60 mL/min/1.73 m2.

Stop baricitinib after 14 days...or earlier if patients are discharged, consistent with the clinical trial.

Get our chart, Treatments of Interest for COVID-19, for other potential agents and more on EUAs.

Key References

  • N Engl J Med Published online Dec 11, 2020; doi:10.1056/NEJMoa2031994
  • www.fda.gov/media/143823/download (12-23-20)
  • www.covid19treatmentguidelines.nih.gov/ (12-23-20)
  • Pharmacotherapy 2020;40(8):843-56
  • Medication pricing by Elsevier, accessed Dec 2020
Hospital Pharmacist's Letter. January 2021, No. 370115

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