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original EUA from November 19, 2020 required baricitinib to be used with remdesivir (Veklury) but this requirement has been revoked.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original EUA from November 19, 2020 required baricitinib to be used with remdesivir (Veklury) but this requirement has been revoked.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
- What are the new drugs for rheumatoid arthritis (RA)?
- What are JAK inhibitors and how do they work?
- Which JAK inhibitors are approved in the U.S?
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/.
Read next
How effective is Olumiant for alopecia (hair loss)?
In studies, about 17% to 35% of adults with severe alopecia areata achieved an 80% or greater scalp hair coverage at 36 weeks, as well as eyebrow and eyelash regrowth, depending upon their Olumiant dose. Some patients using the higher 4 mg dose saw 80% scalp hair regrowth at 24 weeks. Continue reading
Can you have Covid without a fever?
Yes, you can have Covid (coronavirus) without fever or with a very low-grade fever that is hardly noticeable, particularly with the Omicron variant. It is also possible to have Covid-19 with no symptoms at all and the only way you would know this is if you took a Covid-19 test. People infected with the coronavirus who have no symptoms can still spread COVID-19 to others. Continue reading
Can you become immune to COVID-19?
Patients who recover from COVID-19 make antibodies to the virus that may impart immunity for at least 6 months; however, breakthrough infections do occur and may be more likely with newly circulating variants of the virus. Immunizing with the latest recommended COVID-19 vaccine can help to extend your immunity and prevent disease. Continue reading
Related medical questions
- What type of drug is Olumiant (baricitinib)?
- Which breathing techniques help with COVID-19?
- Is Omicron worse than Delta?
- How effective is Lagevrio (molnupiravir) for COVID-19?
- Is obesity a major risk factor for Covid-19?
- Should I wear a face mask to protect myself from COVID-19?
- COVID-19 vaccines and variants: What you should know
- COVID-19: Why is social distancing so important?
- Why do more men die from coronavirus?
- Can Ivermectin be used to treat COVID-19?
- Can you take Ibuprofen if you have COVID-19 (coronavirus)?
- What antibiotics kill Covid-19 (coronavirus)?
- COVID-19: What are the Stages and Causes of Death?
- What's the difference between Bacteria and Viruses?
- Does Zinc protect you from Covid-19 or boost your immune system?
- How do I Treat Nasal Congestion with COVID-19?
- Does Losartan block the receptor used by the Coronavirus?
- An Update: Is hydroxychloroquine effective for COVID-19?
- Where can I buy an at-home test kit for COVID-19 (coronavirus)?
- Can you take Paxlovid twice if COVID rebounds?
- Does Mucinex help with Covid?
- Does Tamiflu (oseltamivir) work on COVID-19?
- Can vitamin C prevent or treat COVID-19 (coronavirus)?
- Should I take Paxlovid after a Positive COVID-19 Test?
- Can I take NyQuil with COVID or after the COVID vaccine?
- How long does COVID-19 last? and other COVID-19 FAQ
- When should you take Paxlovid?
- How effective is Paxlovid for COVID-19?
- Do ACE inhibitors make COVID-19 worse?
- Can you take Ibuprofen after the COVID booster vaccine?
Drug information
Related support groups
- Olumiant (6 questions, 4 members)
- Baricitinib (3 questions, 4 members)
- COVID-19 (105 questions, 87 members)
- Rheumatoid Arthritis (324 questions, 1,318 members)