Baricitinib

(Olumiant®)

Olumiant®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 1 mg, 2 mg, 4 mg)
Drug ClassJanus kinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Latest News

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Summary
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  • Olumiant (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
  • This summary is based on the review of 30 systematic reviews/meta-analyses. [1-30]
  • Clinical Disease Activity Index (CDAI) Remission and Low Disease Activity (LDA): In real-world settings, baricitinib achieved CDAI remission rates ranging from 8.7% to 60% at week 12 and CDAI LDA rates between 20.2% and 81.6% at week 24 in rheumatoid arthritis (RA) patients.
  • Simple Disease Activity Index (SDAI) Remission: Baricitinib demonstrated SDAI remission rates of 12% at week 4, increasing to 45.4% by week 24 in RA patients.
  • Comparison with Other JAK Inhibitors: Baricitinib was found to have lower probabilities of achieving remission and LDA compared to other JAK inhibitors like upadacitinib and tofacitinib, as indicated by a Bayesian network meta-analysis.
  • Effectiveness in COVID-19: Baricitinib was recommended by the WHO for severe COVID-19 due to its proven efficacy in reducing mortality, particularly in patients requiring supplemental oxygen, with supportive evidence from the ACTT-2 and COV-BARRIER trials.
  • Infection Risk: Baricitinib was associated with an increased risk of infections, particularly herpes zoster, with higher rates of treatment-emergent adverse events (TEAEs) compared to placebo.
  • Serious Infections: The risk of serious infections was elevated with baricitinib use, especially in real-world settings, although no new safety signals were identified.
  • COVID-19 Specific Safety: Baricitinib did not increase the incidence of adverse outcomes in COVID-19 patients, though caution is advised due to the potential for immunosuppression.
  • Subgroup Findings: Baricitinib demonstrated variable remission rates between early and established rheumatoid arthritis (RA) patients, with higher remission rates in early RA (27-72%) compared to established RA (14-20%). In COVID-19 patients, baricitinib was particularly effective in reducing mortality in those requiring supplemental oxygen or non-invasive ventilation. The drug was primarily studied in older female RA patients with long disease duration and showed effectiveness in treating alopecia areata (AA) and atopic dermatitis (AD) with favorable safety profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Olumiant (baricitinib) Prescribing Information.2022Lilly USA, LLC, Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systematic literature review of real-world evidence on baricitinib for the treatment of rheumatoid arthritis.2023Rheumatology and Therapy
The gap in knowledge about tapering targeted therapy being used as monotherapy in rheumatoid arthritis: a systematic review.2023Current Rheumatology Reviews
Relative remission and low disease activity rates of tofacitinib, baricitinib, upadacitinib, and filgotinib versus methotrexate in patients with disease-modifying antirheumatic drug-naive rheumatoid arthritis.2023Pharmacology
Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis.2022The Lancet
JAK inhibitors and COVID-19.2022Journal for the ImmunoTherapy of Cancer
Janus kinase (JAK)-inhibitors and coronavirus disease 2019 (Covid-19) outcomes: a systematic review and meta-analysis.2022Expert Review of Anti-Infective Therapy
Efficacy and safety of immunomodulators in patients with COVID-19: a systematic review and network meta-analysis of randomized controlled trials.2022Infectious Diseases and Therapy
The efficacy and safety of Janus kinase inhibitors for patients with COVID-19: a living systematic review and meta-analysis.2022Frontiers in Medicine
Therapeutic and anti-inflammatory effects of baricitinib on mortality, ICU transfer, clinical improvement, and CRS-related laboratory parameters of hospitalized patients with moderate to severe COVID-19 pneumonia: a systematic review and meta-analysis.2022Expert Review of Respiratory Medicine
Effectiveness and safety of baricitinib in patients with alopecia areata: a systematic review and meta-analysis of randomized controlled trials.2022Current Medical Research and Opinion
Systemic immunomodulatory treatments for atopic dermatitis update of a living systematic review and network meta-analysis.2022JAMA Dermatology
Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate-to-severe atopic dermatitis: a network meta-analysis.2022Dermatologic Therapy
Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors.2022Journal of the European Academy of Dermatology & Venerology
Baricitinib for the management of sars-cov-2-infected patients: a systematic review and meta-analysis of randomised controlled trials.2022Canadian Journal of Infectious Diseases and Medical Microbiology
Efficacy and safety of baricitinib for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis of randomized clinical trials.2022Clinical and Experimental Pharmacology and Physiology
Efficacy and safety of different doses of baricitinib for rheumatoid arthritis: a Bayesian network meta-analysis.2022Medicine
Comparison of adalimumab to other targeted therapies in rheumatoid arthritis: results from systematic literature review and meta-analysis.2022Journal of Personalized Medicine
Comparative efficacy and safety of peficitinib versus tofacitinib and baricitinib for treatment of rheumatoid arthritis: a systematic review and network meta-analysis. 2021Rheumatlogy and Therapy
Comparative efficacy and safety of Janus kinase inhibitors and biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and network meta-analysis. 2021Therapeutic Advances in Musculoskeletal Disease
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review. 2021Inflammopharmacology
Effect of disease modifying anti-rheumatic drugs on major cardiovascular events: a meta-analysis of randomized controlled trials.2021Scientific Reports
Systematic review for the treatment of older rheumatoid arthritis patients informing the 2020 update of the Japan College of Rheumatology clinical practice guidelines for the management of rheumatoid arthritis. 2021Modern Rheumatology
Pharmacological and non-pharmacological therapeutic strategies in difficult-to-treat rheumatoid arthritis: a systematic literature review informing the EULAR recommendations for the management of difficult-to-treat rheumatoid arthritis. 2021Rheumatic and Musculoskeletal Disease Open
Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider.2021Annals of the Rheumatic Diseases
The use of Janus kinase inhibitors in hospitalized patients with COVID-19: systematic review and meta-analysis. 2021Clinical Epidemiology and Global Health
Clinical efficacy and safety of Janus kinase inhibitors for COVID-19: a systematic review and meta-analysis of randomized controlled trials. 2021Elsevier Public Health Emergency Collection
Efficacy and safety of tofacitinib, baricitinib, and upadacitinib for rheumatoid arthritis: a systematic review and meta-analysis.2020Mayo Clinic Proceedings
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research.2020RMD Open
Safety and efficacy of newer biologics DMARDs in the management of rheumatoid arthritis: a systematic review.2020Osteoarthritis and Cartilage Open
A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis.2019Rheumatology

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