Is baricitinib (Olumiant) being used to treat COVID-19?
Yes, baricitinib (Olumiant) has FDA approval to treat COVID-19 patients who are
- 18 years and older, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Olumiant has an Emergency Use Authorization (EUA) received from the FDA to treat COVID-19 patients who are:
- 2 years to less than 18 years of age, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
The original EUA from November 19, 2020 required baricitinib to be used with remdesivir (Veklury) but this requirement has been revoked. This means that baricitinib treatment for COVID-19 can be with or without remdesivir.
The original EUA from November 19, 2020 required baricitinib to be used with remdesivir (Veklury) but this requirement has been revoked.
For a medicine to gain FDA approval, the evidence that shows it is effective has to be at a higher level and a larger quantity, compared to gaining EUA approval.
Baricitinib (Olumiant) is also FDA approved to:
- treat adult patients with severe alopecia areata
- treat adult patients with moderately to severely active rheumatoid arthritis who have not responded well to the RA medicines called tumor necrosis factor (TNF) antagonist therapies.
Clinical trials of Baricitinib for COVID-19 Treatment.
The FDA issued the EUA for baricitinib to be used for COVID-19 treatment based on the Phase 3 COV-BARRIER study (NCT04421027). This study was a randomized, double-blind, placebo-controlled study of hospitalized patients which compared baricitinib 4 mg once daily treatment plus standard of care, to placebo treatment with normal standard of care.
The result of this study showed that by day 28:
- Baricitinib patients were less likely to progress to needing ventilation or dying (Baricitinib group 27.8% and placebo group 30.5%)
- Baricitinib group had a reduced the risk of death (Baricitinib 8% and placebo group 13%)
Related questions
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What to know about baricitinib
Baricitinib is a janus kinase (JAK) inhibitor, which inhibits both the JAK1 and JAK2 subtypes. Janus kinase, and other protein kinases, are enzymes that regulate the biological activity of proteins in our body.
Baricitinib comes in the form of an oral tablet that is already approved by the US Food and Drug Administration (FDA) for the treatment of certain patients with rheumatoid arthritis. Long-term use of the drug is known to be associated with an increased risk of serious infection, lymphoma and other cancers, as well as blood clots. COVID-19 patients, however, won’t be on the treatment long term and will just receive a short, 2-week course of the drug.
Why is baricitinib being investigated for COVID-19?
Baricitinib has anti-inflammatory properties and it is hoped that it could help against the inflammatory cytokine storm seen in severe cases of COVID-19.
Research into baricitinib has also shown that it is also capable of inhibiting NAKs (numb-associated kinases). NAKs are thought to regulate the process by which SARS-CoV-2, the virus that causes COVID-19, infects cells. This process is called clathrin-mediated endocytosis. Baricitinib is expected to be more effective than other similar drugs because it has a particular high affinity for AAK1 (adaptor-associated kinase 1), which is a part of the NAK family of kinases.
How was baricitinib identified as a possible treatment for COVID-19?
In February 2020, the UK-based company BenevolentAI, made use of its artificial intelligence (AI) platform to identify baricitinib as a potential treatment for COVID-19. The company integrates AI technologies into the drug discovery process. Benevolent used its technology to try and identify an existing drug that could stop COVID-19 progressing, inhibit the cytokine storm seen in severe cases and also reduce damage caused by the inflammation associated with the disease.
Bottom line:
- Baricitinib is FDA approved to treat COVID-19 patients who are 18 years and older, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
- Baricitinib has an Emergency Use Authorization (EUA) to treat COVID-19 patients who are 2 years to less than 18 years of age, who are hospitalized and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
- Baricitinib plus standard care was shown in the COV-BARRIER study to reduce the risk of needing ventilation or dying, when compared to placebo plus standard care.
References
- Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. [Accessed September 11, 2021] https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00331-3/fulltext
- Baricitinib and Remdesivir Combination Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19. [Accessed September 11, 2021].
https://www.drugs.com/clinical_trials/baricitinib-remdesivir-combination-receives-emergency-authorization-fda-hospitalized-patients-covid-19037.html - FDA Broadens Existing Emergency Use of Lilly and Incyte's Baricitinib in Patients Hospitalized with COVID-19 Requiring Oxygen. [Accessed September 11, 2021].
https://www.drugs.com/clinical_trials/fda-broadens-existing-emergency-lilly-incyte-s-baricitinib-patients-hospitalized-covid-19-requiring-19513.html - Clinicaltrial.govt. Safety and Efficacy of Baricitinib for COVID-19. [Accessed September 11, 2021] Available online at: https://clinicaltrials.gov/ct2/show/NCT04340232?term=baricitinib&draw=2&rank=2.
- Lilly. Lilly Begins Clinical Testing of Therapies for COVID-19. April 10, 2020. [Accessed April 17, 2020]. Available online at: https://investor.lilly.com/news-releases/news-release-details/lilly-begins-clinical-testing-therapies-covid-19.
- Dailymed. OLUMIANT- baricitinib tablet, film coated. November 13, 2019. [Accessed April 17, 2020]. Available online at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=866e9f35-9035-4581-a4b1-75a621ab55cf.
- Stebbing J, Phelan A, Griffin I, et al. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet. 20(4), p400-402, April 01, 2020. DOI: https://doi.org/10.1016/S1473-3099(20)30132-8.
- Tech Crunch. Potential new treatment for COVID-19 uncovered by BenevolentAI enters trials. April 15, 2020. [Accessed April 17, 2020]. Available online at: https://techcrunch.com/2020/04/14/potential-new-treatment-for-covid-19-uncovered-by-benevolentai-enters-trials/.
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