Upadacitinib

(Rinvoq®)

Upadacitinib

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Drug updated on 4/18/2024

Dosage FormExtended-release tablet (oral; 15 mg, 30 mg, 45 mg)
Drug ClassJanus kinase 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 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.

Summary
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  • Upadacitinib (Rinvoq) is indicated for the treatment of adults and pediatric patients 12 years of age and older with various conditions including moderately to severely active rheumatoid arthritis, active psoriatic arthritis, refractory moderate to severe atopic dermatitis, moderately to severely active ulcerative colitis, active ankylosing spondylitis, and non-radiographic axial spondyloarthritis. These indications are for individuals who have had an inadequate response or intolerance to one or more TNF blockers.
  • A total of 58 systematic reviews/meta-analyses focused on Rinvoq's use in treating these conditions compared with other drugs.
  • The safety profile evaluation across a range of immune-mediated inflammatory diseases suggests that upadacitinib has no statistically significant difference in safety outcomes compared to other treatments or placebo. However, certain adverse events such as herpes zoster, headache, acne, elevated blood creatinine phosphokinase, and nausea were reported more frequently among individuals treated with JAK inhibitors like upadacitinib.
  • For atopic dermatitis specifically, while upadacitinib demonstrated superior effectiveness over other systemic treatments, it also showed some increased risks related to its mechanism as a JAK inhibitor.
  • In terms of efficacy, Rinvoq shows substantial improvements across disease metrics. It was found particularly effective when used either alone or as part of a regimen along with methotrexate against rheumatoid arthritis, showing superiority over TNF blockers and methotrexate alone.
  • At doses between 15mg - 30mg daily for atopic dermatitis patients, higher odds of achieving significant skin clearance improvement symptoms were observed when compared against dupilumab and other systemic treatments within short-term periods (up to 16 weeks).
  • In cases involving ulcerative colitis, especially during induction and maintenance remission phases, high dosages proved effective.
  • The evidence particularly supports upadacitinib's use after an inadequate response or intolerance to TNF blockers or conventional therapy among both adult and pediatric patients (12 years and older) suffering from moderately to severely active forms of the conditions treated with Rinvoq.
  • When compared against other JAK inhibitors like abrocitinib and baricitinib, as well as biologics such as dupilumab for atopic dermatitis, upadacitinib often ranked favorably in efficacy for treating specified conditions. However, a dose-dependent increase in adverse events was noted, suggesting a trade-off between efficacy and safety that needs careful consideration.
  • Most studies underline the importance of long-term observations to fully understand potential safety concerns associated with Rinvoq, especially concerning major cardiovascular events and malignancies, given these adverse events typically have prolonged courses.

Product Monograph / Prescribing Information

Document TitleYearSource
Rinvoq (upadacitinib) Prescribing Information.2022AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials.2024Journal of the European Academy of Dermatology and Venereology
Improvement in work productivity among psoriatic arthritis patients treated with biologic or targeted synthetic drugs: a systematic literature review and meta-analysis.2024Arthritis Therapy & Research
Safety of upadacitinib in immune-mediated inflammatory diseases: systematic literature review of indirect and direct treatment comparisons of randomized controlled trials.2024Advances in Therapy
Comparing binary efficacy outcomes for systemic immunomodulatory treatments for atopic dermatitis in a living systematic review and network meta-analysis.2024British Journal of Dermatology
Effectiveness of systemic treatments on pruritus associated with atopic dermatitis: a systematic review in pediatric patients.2024Pediatric Dermatology
Elevation of creatine phosphokinase in moderate-severe atopic dermatitis is associated with the use of JAK inhibitors but not dupilumab: a systematic review and meta-analysis.2024Journal of American Academy of Dermatology
Practical use of upadacitinib in patients with severe atopic dermatitis in a real-world setting: a systematic review.2024Clinical, Cosmetic, and Investigational Dermatology
Janus kinase inhibitors in atopic dermatitis: an umbrella review of meta-analyses.2024Frontiers in Immunology
Comparative maintenance performance of all biologic agents and small molecules in ulcerative colitis: a network meta-analysis.2024European Journal of Gastroenterology & Hepatology
Janus kinase inhibitors and adverse events of acne: a systematic review and meta-analysis.2023JAMA Dermatology
Systemic treatments for atopic dermatitis (eczema): systematic review and network meta-analysis of randomized trials.2023Journal of Allergy and Clinical Immunology
Short-term efficacy and safety of biologics and Janus kinase inhibitors for patients with atopic dermatitis: a systematic review and meta-analysis.2023Heliyon
Reproductive safety issues of novel small molecules for the treatment of inflammatory bowel disease: a systematic review.2023Journal of Clinical Medicine
Upadacitinib in crohn’s disease: a comprehensive systematic review of efficacy and safety.2023Cureus
Efficacy and safety of abrocitinib and upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a systematic review and meta-analysis.2023Heliyon
Efficacy of biological therapies and small molecules in induction and maintenance of remission in luminal Crohn’s disease: systematic review and network meta-analysis.2023Gut
The efficacy and safety of biologic drugs in the treatment of moderate-severe Crohn’s disease: a systematic review.2023Pharmaceuticals
Comparative efficacy and safety of bimekizumab in axial spondyloarthritis: a systematic literature review and network meta-analysis.2023Rheumatology
Comparative of the effectiveness and safety of biological agents, small molecule drugs, and microbiome therapies in ulcerative colitis: Systematic review and network meta-analysis.2023Medicine Open
Association of risk of incident acne and treatment with systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and meta-analysis.2023Inflammation Research
Comparative speed of early symptomatic remission with advanced therapies for moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2023American Journal of Gastroenterology
Efficacy and safety of Janus kinase inhibitors in patients with psoriasis and psoriatic arthritis: a systematic review and meta-analysis.2023Clinical Rheumatology
Impact of upadacitinib on the risk of digestive events in patients with rheumatoid arthritis: a systematic review and meta-analysis of randomized controlled trials.2023Heliyon
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-analysis.2023European Review for Medical and Pharmacological Science
Comparative onset of effect of biologics and small molecules in moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.2023EClinicalMedicine
Oral Janus kinase inhibitors in the treatment of atopic dermatitis: a systematic review and meta-analysis.2023Skin Health and Disease
Are Janus kinase inhibitors safe and effective in treating the key clinical domains of psoriatic arthritis? A systematic review and meta-analysis.2023International Journal of Rheumatic Diseases
Systemic immunomodulatory treatments for atopic dermatitis update of a living systematic review and network meta-analysis.2022JAMA Dermatology
Association between Janus kinase inhibitors therapy and mental health outcome in rheumatoid arthritis: a systematic review and meta-analysis. 2022Rheumatology and Therapy
The safety of systemic Janus kinase inhibitors in atopic dermatitis: a systematic review and network meta analysis.2022European Journal of Clinical Pharmacology
Long-term effectiveness and safety of biologic and small molecule drugs for moderate to severe atopic dermatitis: a systematic review.2022Life
Comparative effectiveness of guselkumab in psoriatic arthritis: updates to a systematic literature review and network meta-analysis.2022Rheumatology
Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate-to-severe atopic dermatitis: a network meta-analysis.2022Dermatologic Therapy
Comparative efficacy of targeted systemic therapies for moderate to severe atopic dermatitis without topical corticosteroids: systematic review and network meta-analysis.2022Dermatology and Therapy
Comparative efficacy and safety of Janus kinase inhibitors and secukinumab in patients with active ankylosing spondylitis: a systematic review and meta-analysis.2022Pharmacology
Association of risk of incident venous thromboembolism with atopic dermatitis and treatment with Janus kinase inhibitors: a systematic review and meta-analysis.2022JAMA Dermatology
Efficacy and safety of JAK inhibitors in the treatment of psoriasis and psoriatic arthritis: a systematic review and meta-analysis.2022BMC Rheumatology
Comparative efficacy and safety of monoclonal antibodies and janus kinase inhibitors in moderate-to-severe atopic dermatitis: a systematic review and meta-analysis.2022Acta Dermato-venereologica
Efficacy of biologics and oral small molecules for atopic dermatitis: a systematic review and meta-analysis.2022Journal of Dermatological Treatment
Efficacy and safety of Janus kinase inhibitors for the treatment of atopic dermatitis: a systematic review and meta-analysis.2022Dermatology
Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis: a systematic literature review and network meta-analysis.2021Journal of the European Academy of Dermatology and Venereology
Systemic treatments in the management of atopic dermatitis: a systematic review and meta-analysis.2021European Journal of Allergy and Clinical Immunology
Short-term effectiveness and safety of biologics and small molecule drugs for moderate to severe atopic dermatitis: a systematic review and network meta-analysis.2021Life
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
Systematic review on the efficacy and safety of oral Janus kinase inhibitors for the treatment of atopic dermatitis. 2021Frontiers in Medicine
The efficacy of Janus kinase inhibitors in patients with atopic dermatitis: a systematic review and network meta-analysis. 2021Dermatologic Therapy
Efficacy and safety of Janus kinase inhibitors for the treatment of atopic dermatitis: a systematic review and meta-analysis. 2021Dermatology
Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis.2021Gut
Comparative efficacy and tolerability of Janus kinase inhibitor therapies for moderate to severe Crohn’s disease: α network meta-analysis.2021Journal of Gastrointestinal and Liver Diseases
Biological therapies for atopic dermatitis: a systematic review.2021Dermatology
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 trials. 2020Zeitschrift für Rheumatologie
Efficacy and safety of tofacitinib, baricitinib, and upadacitinib for rheumatoid arthritis: a systematic review and meta-analysis. 2020Mayo Clinic
Comparative efficacy and safety of tofacitinib, baricitinib, upadacitinib, filgotinib and peficitinib as monotherapy for active rheumatoid arthritis.2020Journal of Clinical Pharmacy and Therapeutics
Comparative efficacy of JAK inhibitors for moderate-to-severe rheumatoid arthritis: a network meta-analysis.2020Advances in Therapy
Safety of Janus kinase inhibitors in patients with inflammatory bowel diseases or other immune-mediated diseases: a systematic review and meta-analysis.2020Gastroenterology
Comparison of Janus kinase inhibitors in the treatment of rheumatoid arthritis: a systemic literature review. 2019Immunotherapy
Comparison of the efficacy and safety of tofacitinib and upadacitinib in patients with active rheumatoid arthritis: a Bayesian network meta-analysis of randomized controlled trials. 2019International Journal of Rheumatic Diseases
A systematic review and meta-analysis of infection risk with small molecule JAK inhibitors in rheumatoid arthritis. 2019Rheumatology
Impact of Janus kinase inhibitors on risk of cardiovascular events in patients with rheumatoid arthritis: systematic review and meta-analysis of randomised controlled trials.2019Annals of Rheumatic Diseases

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