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Upadacitinib

(Rinvoq®)

Rinvoq®

Drug updated on 10/29/2024

Dosage FormExtended-release tablet (oral; 15 mg, 30 mg, 45 mg), Oral solution (oral; 1 mg/mL)
Drug ClassJanus kinase (JAK) inhibitors
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blocker
  • Indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable
  • Indicated for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blocker
  • Indicated for the treatment of adults with moderately to severely active Crohns disease who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
  • Indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy
  • Indicated for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers

Latest News

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Summary
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  • This summary is based on the review of 84 systematic review(s)/meta-analysis(es). [1-84]
  • Upadacitinib demonstrated significant effectiveness in adolescents with moderate-to-severe atopic dermatitis (AD), showing improved outcomes on the Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (IGA), particularly at the 200 mg dose compared to lower doses.
  • In difficult-to-treat rheumatoid arthritis (RA) patients, upadacitinib showed effectiveness but was not the top performer when compared to tocilizumab and rituximab, indicating variability in treatment response among different populations.
  • For axial spondyloarthritis (AxSpA) patients, upadacitinib provided promising results initially, but efficacy waned over time, suggesting the need for continuous assessment in this population.
  • Upadacitinib was associated with an increased risk of infections, including herpes zoster, in adult inflammatory bowel disease (IBD) patients, highlighting the importance of monitoring for adverse events in this subgroup.
  • In adolescents with atopic dermatitis (AD), upadacitinib was associated with a higher incidence of adverse events (AEs), with odds ratios (OR) of 1.57 for the 15 mg dose and 2.21 for the 30 mg dose, although serious adverse events (SAEs) showed no significant difference compared to placebo.
  • Upadacitinib demonstrated no significant safety concerns in rheumatoid arthritis (RA) patients when compared to placebo, with no significant differences in SAEs among various JAK inhibitors.
  • In patients with ulcerative colitis (UC), upadacitinib was linked to an increased risk of infections and herpes zoster, indicating the need for continuous monitoring of long-term safety.
  • Among psoriatic arthritis (PsA) patients, upadacitinib showed an increased risk of infections, but no significant differences in SAEs were reported across different JAK inhibitors, suggesting similar safety profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Rinvoq (upadacitinib) Prescribing Information.2024AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis in adolescents: A systematic review and meta-analysis of randomized controlled trials2024Medicine
Efficacy and safety of current therapies for difficult-to-treat rheumatoid arthritis: a systematic review and network meta-analysis2024Journal of Translational Medicine
Efficacy and Safety of Upadacitinib for Axial Spondyloarthritis: A Systematic Review and Meta-Analysis2024Current Rheumatology Reviews
Small molecules for inflammatory bowel disease and the risk of infection and malignancy: A systematic review and meta-Analysis2024Digestive and Liver Disease
Efficacy and safety of upadacitinib in the treatment of moderate-to-severe atopic dermatitis: A systematic review2024 PloS One
Systematic review and network meta-analysis of the risk of malignancy with biologic therapies and selective Janus kinase-1 inhibitors in atopic dermatitis2024Postepy Dermatologii i Alergologii
The efficacy and safety of different Janus kinase inhibitors as monotherapy in rheumatoid arthritis: A Bayesian network meta-analysis2024PloS One
The efficacy and safety of JAK inhibitors in patients with adult-onset still's disease: A meta-analysis and systematic review2024International Immunopharmacology
Effectiveness and safety of systemic therapy for moderate-to-severe atopic dermatitis in children and adolescent patients: a systematic review2024Frontiers in Immunology
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
Systematic review and network meta-analysis of the risk of Herpes zoster with biological therapies and selective Janus kinase-1 inhibitors in atopic dermatitis2024Postepy Dermatologii i Alergologii
Assessing the economics of biologic and small molecule therapies for the treatment of moderate to severe ulcerative colitis in Japan: a cost per responder analysis of upadacitinib2024Journal of Medical Economics
Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis2024Annals of the Rheumatic Diseases
Practical Use of Upadacitinib in Patients with Severe Atopic Dermatitis in a Real-World Setting: A Systematic Review2024Clinical, Cosmetic and Investigational Dermatology
Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis2024European Journal of Gastroenterology & Hepatology
Janus kinase inhibitors in atopic dermatitis: an umbrella review of meta-analyses2024 Frontiers in Immunology
Improvement in work productivity among psoriatic arthritis patients treated with biologic or targeted synthetic drugs: a systematic literature review and meta-analysis2024 Arthritis Research & Therapy
Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis2024Health Technology Assessment (Winchester, England)
Safety of Upadacitinib in Immune-Mediated Inflammatory Diseases: Systematic Literature Review of Indirect and Direct Treatment Comparisons of Randomized Controlled Trials2024Advances in Therapy
A systematic review of Janus kinase inhibitors and spleen tyrosine kinase inhibitors for Hidradenitis suppurativa treatment2024 International Immunopharmacology
Comparative efficacy of systemic treatments for atopic dermatitis in adults2024Expert Review of Clinical Immunology
Effectiveness of systemic treatments on pruritus associated with atopic dermatitis: A systematic review in pediatric patients2024Pediatric Dermatology
Effectiveness and safety of upadacitinib for inflammatory bowel disease: A systematic review and meta-analysis of RCT and real-world observational studies2024International Immunopharmacology
Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis2024Rheumatology (Oxford, England)
Comparing binary efficacy outcomes for systemic immunomodulatory treatments for atopic dermatitis in a living systematic review and network meta-analysis2024 The British Journal of Dermatology
The safety of systemic Janus kinase inhibitors in atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials2024Journal of the European Academy of Dermatology and Venereology
Relative remission rates of Janus kinase inhibitors in comparison with adalimumab in patients with active rheumatoid arthritis: a network meta-analysis2024 Zeitschrift Für Rheumatologie
Efficacy and safety of upadacitinib for the treatment of moderate-to-severe atopic dermatitis: a systematic review and meta-analysis2023Postepy Dermatologii i Alergologii
Upadacitinib in Crohn's Disease: A Comprehensive Systematic Review of Efficacy and Safety2023Cureus
Reproductive Safety Issues of Novel Small Molecules for the Treatment of Inflammatory Bowel Disease: A Systematic Review2023 Journal of Clinical Medicine
Short-term efficacy and safety of biologics and Janus kinase inhibitors for patients with atopic dermatitis: A systematic review and meta-analysis2023Heliyon
The Efficacy and Safety of Biologic Drugs in the Treatment of Moderate-Severe Crohn's Disease: A Systematic Review2023Pharmaceuticals (Basel, Switzerland)
Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: Systematic review and network meta-analysis2023Medicine
Cost-effectiveness analysis of bimekizumab for the treatment of active psoriatic arthritis in Sweden2023Journal of Medical Economics
Association of risk of incident acne and treatment with systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and meta-analysis2023Et al [Inflammation Research]
Systemic treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials2023The Journal of Allergy and Clinical Immunology
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
The comparative efficacy and safety of biologics and small molecules for treating patients with ulcerative colitis in Portugal: a systematic literature review and network meta-analysis2023European Review for Medical and Pharmacological Sciences
Impact of upadacitinib on the risk of digestive events in patients with rheumatoid arthritis: A systematic review and meta-analysis of randomized controlled trials2023 Heliyon
Cost-Effectiveness of Emerging Treatments for Atopic Dermatitis: A Systematic Review2023PharmacoEconomics
Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: A systematic review and meta-analysis2023Heliyon
JAK inhibitors and the risk of malignancy: a meta-analysis across disease indications2023Annals of the Rheumatic Diseases
Real-Life Effectiveness and Tolerance of Upadacitinib for Severe Atopic Dermatitis in Adolescents and Adults2023 Advances in Therapy
Oral Janus kinase inhibitors in the treatment of atopic dermatitis: A systematic review and meta-analysis2023 Skin Health and Disease
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
Systematic review with network meta-analysis: Risk of Herpes zoster with biological therapies and small molecules in inflammatory bowel disease2023 Alimentary Pharmacology & Therapeutics
Are Janus kinase inhibitors safe and effective in treating the key clinical domains of psoriatic arthritis? A systematic review and meta-analysis2023International Journal of Rheumatic Diseases
Comparative effectiveness of guselkumab in psoriatic arthritis: updates to a systematic literature review and network meta-analysis2023Rheumatology (Oxford, England)
Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn's disease: systematic review and network meta-analysis2023Gut
Relative efficacy and safety of Janus kinase inhibitors for the treatment of active psoriatic arthritis: a network meta-analysis2023 Zeitschrift Für Rheumatologie
Efficacy of topical and systemic treatments for atopic dermatitis on pruritus: A systematic literature review and meta-analysis2022Frontiers in Medicine
Efficacy and safety of JAK inhibitors in the treatment of psoriasis and psoriatic arthritis: a systematic review and meta-analysis2022 BMC Rheumatology
Long-Term Effectiveness and Safety of Biologic and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review2022Life (Basel, Switzerland)
Association of Risk of Incident Venous Thromboembolism With Atopic Dermatitis and Treatment With Janus Kinase Inhibitors: A Systematic Review and Meta-analysis2022JAMA Dermatology
Comparative Efficacy and Safety of Monoclonal Antibodies and Janus Kinase Inhibitors in Moderate-to-severe Atopic Dermatitis: A Systematic Review and Meta-analysis2022Acta Dermato-Venereologica
Comparative Efficacy and Safety of Janus Kinase Inhibitors and Secukinumab in Patients with Active Ankylosing Spondylitis: A Systematic Review and Meta-Analysis2022Pharmacology
Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate-to-severe atopic dermatitis: A network meta-analysis2022 Dermatologic Therapy
Comparative Efficacy of Targeted Systemic Therapies for Moderate to Severe Atopic Dermatitis without Topical Corticosteroids: Systematic Review and Network Meta-analysis2022Dermatology and Therapy
Comparison of Adalimumab to Other Targeted Therapies in Rheumatoid Arthritis: Results from Systematic Literature Review and Meta-Analysis2022Journal of Personalized Medicine
Systemic Immunomodulatory Treatments for Atopic Dermatitis: Update of a Living Systematic Review and Network Meta-analysis2022JAMA Dermatology
Rheumatoid arthritis and myasthenia gravis: a case-based review of the therapeutic options2022Clinical Rheumatology
Association Between Janus Kinase Inhibitors Therapy and Mental Health Outcome in Rheumatoid Arthritis: A Systematic Review and Meta-analysis2022 Rheumatology and Therapy
Efficacy of biologics and oral small molecules for atopic dermatitis: a systematic review and meta-analysis2022The Journal of Dermatological Treatment
Efficacy and Safety of Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis: A Systematic Review and Meta-Analysis2022Dermatology (Basel, Switzerland)
Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis2021Gut
Short-Term Effectiveness and Safety of Biologics and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review and Network Meta-Analysis2021Life (Basel, Switzerland)
Comparative Efficacy and Tolerability of Janus Kinase Inhibitor Therapies for Moderate to Severe Crohn's Disease: Alpha Network Meta-analysis2021Journal of Gastrointestinal and Liver Diseases
Systematic Review on the Efficacy and Safety of Oral Janus Kinase Inhibitors for the Treatment of Atopic Dermatitis2021Frontiers in Medicine
The efficacy of Janus kinase inhibitors in patients with atopic dermatitis: A systematic review and network meta-analysis2021Dermatologic Therapy
Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis2021Journal of the European Academy of Dermatology and Venereology
Effect of janus kinase inhibitors and methotrexate combination on malignancy in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials2021 Auto- 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
Biologic disease modifying antirheumatic drugs and Janus kinase inhibitors in paediatric rheumatology - what we know and what we do not know from randomized controlled trials2021Pediatric Rheumatology Online Journal
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 Für Rheumatologie
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, and filgotinib in active rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs2021Zeitschrift Für Rheumatologie
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research2020 RMD Open
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 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
Comparative efficacy and safety of 15 and 30 mg upadacitinib administered to patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials2020Zeitschrift Für Rheumatologie

Clinical Practice Guidelines

Document TitleYearSource
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update.2023Annals of the Rheumatic Diseases
Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement.2021Annals of the Rheumatic Diseases
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. 2020Annals of the Rheumatic Diseases
Updated Greek Rheumatology Society Guidelines for the Management of Rheumatoid Arthritis.2020Mediterranean Journal of Rheumatology