Put the EUA for Baricitinib Plus Remdesivir in Perspective

Posted December 8, 2020: Article in Progress. We’re releasing this article ahead of our January 2021 issue to quickly provide information to our readers. The information contained in this version is based on the best evidence available to us as of the date of posting. The final version may include revised recommendations. This article is from Hospital Pharmacist's Letter and contains wording directed specifically to that audience. However, the editors are providing it to this Letter's readers due to its potentially relevant content.

The oral rheumatoid arthritis med baricitinib (Olumiant) is now authorized to treat COVID-19 in hospitalized patients age 2 and up.

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

Explain that unpublished data suggest that ADDING baricitinib to remdesivir (Veklury) reduces recovery time by 1 day...compared to remdesivir alone.

This is in hospitalized patients requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

But so far, this combo doesn’t seem to reduce mortality.

Be aware, baricitinib is only authorized for use with remdesivir...and can’t be used by itself.

Also there’s no good evidence for using baricitinib with corticosteroids to treat COVID-19. But patients on supplemental oxygen will be on dexamethasone...the only med to date with a mortality benefit.

And it’s too soon to know baricitinib’s risks in COVID-19 patients.

Baricitinib can increase infection risk in patients with rheumatoid arthritis. And there’s not enough data to say if adding baricitinib to a steroid for COVID-19 will further increase this risk.

Plus baricitinib has a boxed warning for venous thromboembolism (VTE)...which is already a concern in patients with COVID-19.

And the higher 4 mg/day baricitinib dose used for COVID-19 isn’t FDA-approved for rheumatoid arthritis...due to an increased VTE risk.

There doesn’t seem to be a significant difference in VTE between baricitinib and placebo now. But clarify that this is based on a small number of patient events. More data are needed to know the true risk.

Be aware, baricitinib will cost $150/day for up to 14 days. This is in addition to over $500/day for remdesivir.

Continue to start dexamethasone in patients requiring supplemental oxygen, mechanical ventilation, or ECMO. Consider ADDING remdesivir...especially in those on low-flow oxygen.

If baricitinib is used for COVID-19, follow the emergency use authorization (EUA). For example, use VTE prophylaxis unless contraindicated...and adjust doses for eGFR under 60 mL/min/1.73 m2.

Explain potential risks and benefits to patients...give them an EUA fact sheet...and document your discussion.

Stop baricitinib before 14 days if your patient is discharged...since this is how it was studied.

References

  1. https://www.fda.gov/media/143823/download
  2. https://www.fda.gov/media/143825/download
  3. https://www.covid19treatmentguidelines.nih.gov/
  4. Pharmacotherapy. 2020 Aug;40(8):843-856
  5. https://clinicaltrials.gov/ct2/show/NCT04401579
  6. Medication pricing by Elsevier, accessed Dec 2020