Contents

Search

baricitinib (Olumiant)

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] - baricitinib increases hair regrowth by >= 75% at 12-26 weeks [11] * included in NIAID Adaptive COVID-19 Treatment Trial. Dosage: - 4 mg PO QD Tabs: 1,2 4 mg Adverse effects: - infections - major adverse cardiovascular events Laboratory: - small reductions in neutrophil count - minor increases in serum creatinine - minor increases in LDL cholesterol Mechanism of action: - Janus kinase inhibitor - preferential JAK1/JAK2 inhibitor [1] Management: - whenever possible bring patients up to date on vaccinations prior to initiating biologic immunosuppressive agent [9]

Interactions

drug adverse effects of immunosuppressive agents monitor with immunosuppressive agents

General

Janus kinase inhibitor; JAK inhibitor biologic immunosuppressive agent (biologic agent, biologic immune modulator) disease-modifying antirheumatic agent (DMARD)

Database Correlations

PUBCHEM correlations

References

  1. 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: 27028914
  2. 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. 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. 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: 33306283 PMCID: PMC7745180 Free PMC article https://www.nejm.org/doi/full/10.1056/NEJMoa2031994
  5. 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: 34235720 https://agsjournals.onlinelibrary.wiley.com/doi/full/10.1111/jgs.17357
  6. 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: 34480861 PMCID: PMC8409066 Free PMC article https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00331-3/fulltext
  7. 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. King B et al. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med 2022 Mar 26; [e-pub]. PMID: 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. Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  10. 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: 35908569 PMCID: PMC9333998 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01109-6/fulltext
  11. 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: 37870096 Review.
  12. Medscape: baricitinib (Rx) https://reference.medscape.com/drug/olumiant-baricitinib-1000107