baricitinib (Olumiant)
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Indications
- rheumatoid arthritis (phase 3 trial)[1]
- systemic lupus erythematosus (phase 2 trial)[2]
- FDA issues emergency use authorization for baricitinib-remdesivir combination to treat hospitalized COVID-19 patients >= 2 years who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation[3]
- superior to remdesivir alone in reducing recovery time for patients receiving high-flow oxygen or non-invasive ventilation[4]
- baricitinib alone (mean total dose of 17.6 mg for a mean number of 5.9 days of treatment, route not defined) associated with an 8.1% reduction in 30-day absolute mortality in patients < 70 years hospitalized with Covid-19 pneumonia, & an 18.5% reduction in 30-day absolute mortality patients >= 70 years[5]
- reduction in 28 day mortality for baricitinib alone 8% vs 13% with placebo in hospitalized patients not on mechanical ventilation[6]
- 13% lower 28-day mortality associated with use of baricitinib alone in patients with severe Covid-19[7]*
- lowers mortality 20% in hospitalized Covid-19 patients requiring oxygen when added to dexamethasone[10]
- FDA-approved for treatment of alopecia areata[8]
* included in NIAID Adaptive COVID-19 Treatment Trial.
Dosage
Tabs: 1,2 4 mg
Adverse effects
- infections
- major adverse cardiovascular events
- drug adverse effects of immunosuppressive agents
- drug adverse effects of biologic immunosuppressive agents
- drug adverse effects of tyrosine kinase inhibitor(s)
- drug adverse effects of janus kinase inhibitors
Laboratory
- small reductions in neutrophil count
- minor increases in serum creatinine
- minor increases in LDL cholesterol
Mechanism of action
Management
- whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent[9]
More general terms
- Janus kinase inhibitor; JAK inhibitor
- biologic immunosuppressive agent
- disease-modifying antirheumatic agent (DMARD)
References
- ↑ 1.0 1.1 1.2 Coblyn JS Baricitinib Might Expand Options for Patients with Refractory Rheumatoid Arthritis NEJM Journal Watch. April 5, 2016 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
Genovese MC et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med 2016 Mar 31; 374:1243 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27028914 - ↑ 2.0 2.1 Walsh N EULAR: Baricitinib Shows Promise in SLE. Significant clinical benefits with JAK inhibition in active lupus. MedPage Today. June 14, 2018 https://www.medpagetoday.com/meetingcoverage/eular/73500
Wallace D, et al Baricitinib in systemic lupus erythematosus: results from a phase 2, randomized, double-blind, placebo-controlled study. European Congress of Rheumatology (EULAR) 2018; abstract OP0019 - ↑ 3.0 3.1 FDA News Release. Nov 19, 2020 Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19
- ↑ 4.0 4.1 Kalil AC, Patterson TF, Mehta AK et al Baricitinib plus Remdesivir for Hospitalized Adults with Covid-19. N Engl J Med 2021; 384:795-807. March 4. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33306283 PMCID: PMC7745180 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa2031994
- ↑ 5.0 5.1 Abizanda P, Calbo Mayo JM, Mas Romero M et al Baricitinib reduces 30-day mortality in older adults with moderate-to-severe COVID-19 pneumonia. J Am Getiatr Soc 2021. July 8 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34235720 https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.17357
- ↑ 6.0 6.1 Marconi VC, Ramanan AV, de Bono S et al. 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. Lancet Respir Med 2021 Sep 1; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/34480861 PMCID: PMC8409066 Free PMC article https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00331-3/fulltext
- ↑ 7.0 7.1 Walker M JAK Inhibitor Shows Mortality Benefit in Severe COVID. U.K.'s RECOVERY trial finds baricitinib cut risk of death when added to usual care. MedPage Today March 4, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/97493
- ↑ 8.0 8.1 King B et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med 2022 Mar 26; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35334197 https://www.nejm.org/doi/10.1056/NEJMoa2110343
Frellick M FDA OKs First Systemic Treatment for Alopecia Areata, Medscape. June 13, 2022 https://www.medscape.com/viewarticle/975487 - ↑ 9.0 9.1 Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
- ↑ 10.0 10.1 RECOVERY Collaborative Group. Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial and updated meta-analysis. Lancet 2022 Jul 30; 400:359 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35908569 PMCID: PMC9333998 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01109-6/fulltext
- ↑ 11.0 11.1 Mateos-Haro M, Novoa-Candia M, Sanchez Vanegas G et al Treatments for alopecia areata: a network meta-analysis. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013719. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37870096 Review.
- ↑ Medscape: baricitinib (Rx) https://reference.medscape.com/drug/olumiant-baricitinib-1000107