Baricitinib

(Olumiant®)

Olumiant®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 1 mg, 2 mg, 4 mg)
Drug ClassJanus kinase (JAK) 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
  • Indicated for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO
  • Indicated for the treatment of adult patients with severe alopecia areata

Latest News

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Summary
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  • This summary is based on the review of 78 systematic review(s)/meta-analysis(es). [1-78]
  • Rheumatoid Arthritis (RA): Baricitinib demonstrated significant improvement in the Disease Activity Score of 28 Joints (DAS28) compared to placebo, with an odds ratio (OR) of 1.24 (95% CI, P = 0.15) in the modified intent-to-treat population, and ranked lower than tocilizumab but higher than opinercept. Additionally, when combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), baricitinib effectively achieved the American College of Rheumatology 20/50/70 Response Criteria (ACR20/50/70) and DAS28(CRP) < 2.6 at 24 weeks.
  • COVID-19: Baricitinib significantly reduced mortality with a relative risk (RR) of 0.68 and demonstrated faster recovery and shorter hospital stays compared to placebo. When combined with Remdesivir, it improved clinical recovery at 14 days and reduced mortality rates.
  • Alopecia Areata (AA): Baricitinib 4 mg resulted in the best efficacy in improving the Severity of Alopecia Tool (SALT) score, particularly showing notable hair regrowth in patients with severe AA (SALT score ≥ 50).
  • Population Considerations: Baricitinib was effective in patients with moderate to severe RA unresponsive to prior treatments, and showed efficacy across various severities of COVID-19 in hospitalized patients. In AA patients, higher doses correlated with more significant improvements in SALT scores, particularly in those with very severe AA (SALT score 95-100).
  • Infection Risks: Baricitinib was associated with a higher risk of any-grade infections (RR 1.34) and opportunistic infections (RR 2.69) compared to other treatments, indicating a notable risk profile for infections relative to filgotinib, peficitinib, and upadacitinib.
  • Adverse Events: While there was an increased risk of adverse events, the rates of serious infections and critical adverse events were not significantly higher compared to placebo. Common adverse events included hypercholesterolemia.
  • Safety Profile: No significant increase in major adverse cardiovascular events (MACE) or venous thromboembolic events (VTE) was observed. Baricitinib had a lower incidence of adverse effects than tocilizumab, particularly regarding secondary infections and thrombotic events in COVID-19 patients.
  • Comparative Safety: In rheumatoid arthritis (RA) studies, rituximab was noted as the safest drug, while baricitinib demonstrated a lower incidence of adverse effects compared to tocilizumab in the context of COVID-19 treatment.
  • RA Population: Baricitinib was studied in patients with moderate to severe RA who were insensitive or under-responsive to conventional synthetic DMARDs, demonstrating efficacy particularly in those with prior biologic DMARD failure.
  • COVID-19 and Alopecia Areata Populations: In COVID-19 patients, efficacy was noted across varied severity levels, especially in those requiring oxygen support, while adults with severe Alopecia Areata (SALT score ≥ 50) showed significant response to baricitinib, with better outcomes in patients with very severe AA (SALT score 95-100).

Product Monograph / Prescribing Information

Document TitleYearSource
Olumiant (baricitinib) Prescribing Information.2022Eli Lilly and Company, Indianapolis, IN

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of current therapies for difficult-to-treat rheumatoid arthritis: a systematic review and network meta-analysis2024Journal of Translational Medicine
Cumulative incidence and risk of infection in patients with rheumatoid arthritis treated with janus kinase inhibitors: A systematic review and meta-analysis2024PLoS One
The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysis2024PLoS One
Comparative efficacy of five approved Janus kinase inhibitors as monotherapy and combination therapy in patients with moderate-to-severe active rheumatoid arthritis: a systematic review and network meta-analysis of randomized controlled trials2024Frontiers in Pharmacology
Comparative efficacy and safety of different drugs in patients with systemic juvenile idiopathic arthritis: A systematic review and network meta-analysis2024Medicine
Baricitinib statistically significantly reduced COVID-19-related mortality: a systematic review and meta-analysis of five phase III randomized, blinded and placebo-controlled clinical trials2024Biology Methods & Protocols
Comparative efficacy of oral Janus kinase inhibitors and biologics in adult alopecia areata: A systematic review and Bayesian network meta-analysis2024Journal of the European Academy of Dermatology and Venereology
Choosing immunomodulating therapies for the treatment of COVID-19: recommendations based on placebo-controlled trial evidence2024Clinical Microbiology and Infection
Relative remission rates of Janus kinase inhibitors in comparison with adalimumab in patients with active rheumatoid arthritis: a network meta-analysis2024Zeitschrift fur Rheumatologie
Comparative efficacy and safety of anti-infective drugs for patients with mild to severe COVID-19: A systematic review and network meta-analysis of randomized controlled trials2023Ethiopian Medical Journal
Efficacy and safety of tocilizumab and baricitinib among patients hospitalized for COVID-19: a systematic review and meta-analysis2023Frontiers in Pharmacology
Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases2023RMD Open
Efficacy and safety of baricitinib in patients with severe COVID-19: A systematic review and meta-analysis2023Medicine
Efficacy and safety of baricitinib for the treatment of hospitalized adults with COVID-19: a systematic review and meta-analysis2023European Journal of Medical Research
Treatments for Moderate-to-Severe Alopecia Areata: A Systematic Narrative Review2023Dermatology and Therapy
Assessment of the available therapeutic approaches for severe COVID-19: a meta-analysis of randomized controlled trials2023Scientific Reports
Systematic Literature Review of Real-World Evidence on Baricitinib for the Treatment of Rheumatoid Arthritis2023Rheumatology and Therapy
Risk of herpes zoster associated with JAK inhibitors in immune-mediated inflammatory diseases: a systematic review and network meta-analysis2023Frontiers in Pharmacology
Relative Remission and Low Disease Activity Rates of Tofacitinib, Baricitinib, Upadacitinib, and Filgotinib versus Methotrexate in Patients with Disease-Modifying Antirheumatic Drug-Naive Rheumatoid Arthritis2023Pharmacology
Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials2023JAMA Dermatology
JAK inhibitors and the risk of malignancy: a meta-analysis across disease indications2023Annals of the Rheumatic Diseases
Efficacy and safety of different JAK inhibitors in the treatment of alopecia areata: a network meta-analysis2023Frontiers in Immunology
Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review2023Clinical Drug Investigation
Adverse events in patients treated with Jak-inhibitors for alopecia areata: A systematic review2023Journal of the European Academy of Dermatology and Venereology
Comparative Efficacy and Safety of Janus Kinase Inhibitors Used in Alopecia Areata: A Systematic Review and Meta-analysis2023Acta Dermato-Venereologica
Herpes zoster in patients with inflammatory arthritides or ulcerative colitis treated with tofacitinib, baricitinib or upadacitinib: a systematic review of clinical trials and real-world studies2023Rheumatology International
Effect of tocilizumab, sarilumab, and baricitinib on mortality among patients hospitalized for COVID-19 treated with corticosteroids: a systematic review and meta-analysis2023Clinical Microbiology and Infection
Janus kinases inhibitors for coronavirus disease-2019: A pairwise and Bayesian network meta-analysis2022Frontiers in Medicine
Efficacy and safety of baricitinib and tocilizumab in hospitalized patients with COVID-19: A comparison using systematic review and meta-analysis2022Frontiers in Pharmacology
Comparative efficacy and safety of JAK inhibitors as monotherapy and in combination with methotrexate in patients with active rheumatoid arthritis: A systematic review and meta-analysis2022Frontiers in Immunology
Efficacy and safety of different doses of baricitinib for rheumatoid arthritis: A Bayesian network meta-analysis2022Medicine
Does baricitinib reduce mortality and disease progression in SARS-CoV-2 virus infected patients? A systematic review and meta analysis2022Respiratory Medicine
The efficacy and safety of JAK inhibitors for alopecia areata: A systematic review and meta-analysis of prospective studies2022Frontiers in Pharmacology
Baricitinib for the Management of SARS-CoV-2-Infected Patients: A Systematic Review and Meta-Analysis of Randomised Controlled Trials2022Canadian Journal of Infectious Diseases and Medical Microbiology
Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis2022The Lancet
Janus kinase inhibitors for the treatment of COVID-192022The Cochrane Database of Systematic Reviews
Efficacy of COVID-19 treatments among geriatric patients: a systematic review2022Therapeutic Advances in Infectious Disease
JAK inhibitors and COVID-192022Journal for Immunotherapy of Cancer
Comparison of Adalimumab to Other Targeted Therapies in Rheumatoid Arthritis: Results from Systematic Literature Review and Meta-Analysis2022Journal of Personalized Medicine
Association Between Janus Kinase Inhibitors Therapy and Mental Health Outcome in Rheumatoid Arthritis: A Systematic Review and Meta-analysis2022Rheumatology and Therapy
Clinical efficacy and adverse events of baricitinib treatment for coronavirus disease-2019 (COVID-19): A systematic review and meta-analysis2022Journal of Medical Virology
Efficacy and Safety of Immunomodulators in Patients with COVID-19: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2022Infectious Diseases and Therapy
Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database2022Annals of the Rheumatic Diseases
Janus kinase (JAK)-inhibitors and coronavirus disease 2019 (Covid-19) outcomes: a systematic review and meta-analysis2022Expert Review of Anti-Infective Therapy
Efficacy and Safety of JAK Inhibitors for Rheumatoid Arthritis: A Meta-Analysis. 2022Journal of Clinical Medicine
Current Use of Baricitinib in COVID-19 Treatment and Its Future: An Updated Literature Review. 2022Cureus
Janus kinase inhibitors for the treatment of COVID‐19. 2022The Cochrane Database of Systematic Reviews
The Efficacy and Safety of Janus Kinase Inhibitors for Patients With COVID-19: A Living Systematic Review and Meta-Analysis2021Frontiers in Medicine
Immunomodulatory therapies for the treatment of SARS-CoV-2 infection: an update of the systematic literature review to inform EULAR points to consider2021RMD Open
Efficacy of COVID-19 Treatments: A Bayesian Network Meta-Analysis of Randomized Controlled Trials2021Frontiers in Public Health
Efficacy and safety of current medications for treating severe and non-severe COVID-19 patients: an updated network meta-analysis of randomized placebo-controlled trials2021Aging
Janus kinase inhibitors and major COVID-19 outcomes: time to forget the two faces of Janus! A meta-analysis of randomized controlled trials2021Clinical Rheumatology
Comparison of the efficacy and safety indicators of DMARDs for rheumatoid arthritis: A network meta-analysis2021Medicine
Clinical efficacy and safety of Janus kinase inhibitors for COVID-19: A systematic review and meta-analysis of randomized controlled trials2021International Immunopharmacology
Current jakinibs for the treatment of rheumatoid arthritis: a systematic review2021Inflammopharmacology
JAK-inhibitors for coronavirus disease-2019 (COVID-19): a meta-analysis2021Leukemia
The use of Janus Kinase inhibitors in hospitalized patients with COVID-19: Systematic review and meta-analysis2021Clinical Epidemiology and Global Health
Safety of Baricitinib 4 mg for the Treatment of Moderate to Severe Rheumatoid Arthritis2021Southern Medical Journal
Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials2021Auto- Immunity Highlights
Comparative efficacy and safety of Janus kinase inhibitors and biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and network meta-analysis2021Therapeutic Advances in Musculoskeletal Disease
Comparative Efficacy and Safety of Peficitinib Versus Tofacitinib and Baricitinib for Treatment of Rheumatoid Arthritis: A Systematic Review and Network Meta-Analysis2021Rheumatlogy and Therapy
Comparative effectiveness and safety of non-tumour necrosis factor biologics and Janus kinase inhibitors in patients with active rheumatoid arthritis showing insufficient response to tumour necrosis factor inhibitors: A Bayesian network meta-analysis of randomized controlled trials2021Journal of Clinical Pharmacy and Therapeutics
Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider2021Annals of the Rheumatic Diseases
Comparative study of the efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib versus methotrexate for disease-modifying antirheumatic drug-naive patients with rheumatoid arthritis2021Zeitschrift fur Rheumatologie
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in active rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs2021Zeitschrift fur Rheumatologie
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
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research2020RMD Open
Safety and efficacy of newer biologics DMARDs in the management of rheumatoid arthritis: A systematic review2020Osteoarthritis and Cartilage Open
Immune Therapy, or Antiviral Therapy, or Both for COVID-19: A Systematic Review2020Drugs
Systematic review on tuberculosis risk in patients with rheumatoid arthritis receiving inhibitors of Janus Kinases2020Expert Opinion on Drug Safety
Efficacy and Safety of Tofacitinib, Baricitinib, and Upadacitinib for Rheumatoid Arthritis: A Systematic Review and Meta-Analysis2020Mayo Clinic Proceedings
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis2020Journal of Clinical Pharmacy and Therapeutics
Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naive to treatment with biologic or conventional synthetic disease-modifying antirheumatic drugs: a matching-adjusted indirect comparison2020RMD Open
Comparative Efficacy of JAK Inhibitors for Moderate-To-Severe Rheumatoid Arthritis: A Network Meta-Analysis2020Advances in Therapy
Safety of synthetic and biological DMARDs: a systematic literature review informing the 2019 update of the EULAR recommendations for the management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis2020Annals of the Rheumatic Diseases
Safety of Janus Kinase Inhibitors in Patients With Inflammatory Bowel Diseases or Other Immune-mediated Diseases: A Systematic Review and Meta-Analysis2020Gastroenterology
Effect of biologics and targeted synthetic disease-modifying anti-rheumatic drugs on fatigue in rheumatoid arthritis2019Rheumatology

Clinical Practice Guidelines

Document TitleYearSource
Pan-American Guidelines for the treatment of SARS-CoV-2/COVID-19: a joint evidence-based guideline of the Brazilian Society of Infectious Diseases (SBI) and the Pan-American Association of Infectious Diseases (API)2023Annals of Clinical Microbiology and Antimicrobials
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update.2023Annals of the Rheumatic Diseases
Guidelines for the Management of Patients with Alopecia Areata in Korea: Part II Systemic Treatment. 2023Annals of Dermatology
Canadian Rheumatology Association Living Guidelines for the Pharmacological Management of Rheumatoid Arthritis With Disease-Modifying Antirheumatic Drugs2022The Journal of Rheumatology
EULAR points to consider for the management of difficult-to-treat rheumatoid arthritis. 2022Annals of the Rheumatic Diseases
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement2021Annals of the Rheumatic Diseases
The Alopecia Areata Consensus of Experts (ACE) study part II: Results of an international expert opinion on diagnosis and laboratory evaluation for alopecia areata. 2021Journal of the American Academy of Dermatology
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update2020Annals of the Rheumatic Diseases
A living WHO guideline on drugs for COVID-19. 2020BMJ