Baricitinib

(Olumiant®)

Baricitinib

Drug updated on 5/17/2024

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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  • Baricitinib (Olumiant) 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 blockers. It has demonstrated significant efficacy in treating this condition, improving clinical outcomes such as remission and low disease activity states.
  • A total of 30 studies were reviewed, providing comprehensive data on Olumiant's effectiveness, safety, comparative performance against other therapeutics including methotrexate and other JAK inhibitors like tofacitinib, upadacitinib, and filgotinib.
  • Real-world evidence supports baricitinib’s effectiveness in various rheumatoid arthritis patient populations, including those with prior biologic/targeted synthetic DMARD use and concomitant conventional synthetic DMARD use, where it showed comparable or superior drug persistence rates compared to anti-TNF drugs.
  • In addition to its role in treating rheumatoid arthritis, baricitinib has shown promising results in reducing mortality from COVID-19 by shortening recovery times and reducing the risk of clinical deterioration, especially among hospitalized patients requiring supplemental oxygen or high-flow oxygen therapy.
  • When directly compared with other JAK inhibitors for RA treatment, as well as traditional DMARDs, baricitinib was often ranked effectively for achieving remission and managing disease activity. It also stood out due to its high persistence rates and improvements in patient-reported outcomes.
  • Baricitinib's safety profile remained consistent across both real-world settings and clinical trials, showing no new safety signals. Common concerns associated with JAK inhibitor usage, such as serious infections, herpes zoster, and potential thromboembolic events, were noted. However, the benefits for specific populations seemed to outweigh these risks, particularly in moderate to severe COVID cases.
  • The drug's effectiveness appeared consistent across a broad range of subgroups, including demographics, disease severities, and prior treatment histories, in both RA and COVID populations. Efforts to taper therapy in controlled RA suggested that dose reduction strategies and early treatments could be more successful.
  • Baricitinib was the only JAK inhibitor recommended in the first line for severe COVID-19 cases by WHO, given its efficacy in reducing mortality as demonstrated in randomized clinical trials.

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

Clinical Practice Guidelines