What type of drug is Olumiant (baricitinib)?
Olumiant is the brand name of the medicine called baricitinib which is a Janus kinase (JAK) inhibitor.
JAK inhibitors are intracellular enzymes that work by interfering with cytokine signaling to influence cell processes of immune cell function and inflammation.
Olumiant is used for rheumatoid arthritis treatment
Olumiant is an FDA approved medicine used alone or in combination with methotrexate or other non-biologic DMARDs for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients with an inadequate response to tumor necrosis factor (TNF) inhibitors.
In clinical trials, Olumiant had a significant response rate in RA compared to placebo after 12 weeks of treatment (49% versus 27% response rate, respectively). According to Eli Lilly, the price of Olumiant will be 60% less than the leading tumor necrosis factor (TNF) inhibitor.
Olumiant is used to treat severe alopecia areata.
Olumiant is a FDA approved medicine to treat adults with severe alopecia areata (severe hair loss).
Results from clinical trials for patients with 50% or greater scalp hair loss:
Olumiant 2mg a day for 36 weeks
- 17-22% patients achieved 80% or more scalp hair coverage.
- 11-13% patients achieved 90% or more scalp hair coverage.
Taking Olumiant 4 mg a day for 36 weeks
- 32-35% patients achieved 80% or more scalp hair coverage.
- 24-26% patients achieved 90% or more scalp hair coverage.
Olumiant can be used for COVID-19 Treatment
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.
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 was studied for the treatment of COVID-19 In the Phase 3 COV-BARRIER study (NCT04421027). This 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 results of the 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?
Bottom line:
- Olumiant (baricitinib) is a JAK inhibitor that influences immune cell function and inflammation.
- Olumiant is an FDA approved medicine used to treat severe alopecia areata and moderate to severe RA that has not responded well to another type of RA medicine called TNF inhibitors.
- Olumiant 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).
- Olumiant 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.
References
- Olumiant Professional Medication Information: [Accessed September 11, 2021] https://www.drugs.com/pro/olumiant.html
- 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
- 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
- Baricitinib Patient Information: [Accessed September 11, 2021] https://www.drugs.com/mtm/baricitinib.html
- FDA Approves Lilly and Incyte's Olumiant (baricitinib) as First and Only Systemic Medicine for Adults with Severe Alopecia Areata [Accessed June 22, 2022] https://www.drugs.com/newdrugs/fda-approves-lilly-incyte-s-olumiant-baricitinib-first-only-systemic-medicine-adults-severe-5851.html
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