What is the information about Rinvoq (Upadacitinib)?

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Dainyal Siddiqui, MD

Internal Medicine

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Manuel Jimenez, MD

Cardiology

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Franz Pierre-Louis, MD

Infectious Disease

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Last updated: May 22, 2025 • View editorial policy

From the Guidelines

Rinvoq (upadacitinib) is a prescription medication that should be used with caution due to its potential risks, including serious infections, blood clots, cancer, and cardiovascular events, and is typically prescribed when other treatments have failed.

Key Points to Consider

  • Rinvoq belongs to a class of drugs called Janus kinase (JAK) inhibitors, which work by reducing inflammation in the body by blocking specific enzymes involved in the immune response 1.
  • It is available as an extended-release tablet taken once daily (15mg or 30mg depending on the condition being treated) 2.
  • Common side effects include upper respiratory infections, nausea, cough, and fever, while more serious risks include increased risk of serious infections, blood clots, cancer, and cardiovascular events 3.
  • Patients should inform their doctor about all medications they're taking and any history of infections, cancer, or blood clots before starting this medication 4.
  • Regular blood tests are necessary to monitor for potential complications, and the medication should not be taken with certain medications that affect the immune system 5.
  • The decision to prescribe Rinvoq should be based on a shared decision between the patient and the medical specialist, taking into account the potential benefits and risks of the therapy 6.

Important Considerations

  • Rinvoq should be used with caution in patients with a history of venous thromboembolism (VTE), as it may increase the risk of VTE 4.
  • Patients with severe active infections, acute or chronic, including latent TB and opportunistic infections, should not use Rinvoq 5.
  • The medication should not be used in patients with current malignancies, severe organ dysfunction, or pregnancy and lactation 5.
  • Regular monitoring of laboratory tests, including full and differential blood counts, liver transaminase tests, and lipid levels, is necessary to detect potential complications early 6.

Recommendations

  • Rinvoq should be prescribed at the recommended dose for the specific disease, and dose adjustments should be considered in patients with higher age, significantly impaired renal or hepatic function, and/or risk of drug interactions 2.
  • The medication should be used cautiously in patients at high risk of major adverse cardiovascular events, and alternative therapeutic options should be considered in women of childbearing age actively contemplating pregnancy 7.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Rinvoq (Upadacitinib) Overview

  • Rinvoq, also known as upadacitinib, is a selective Janus kinase (JAK) inhibitor approved for the treatment of several chronic inflammatory diseases, including rheumatic, dermatologic, and gastrointestinal diseases 8.
  • It works by inhibiting the phosphorylation of downstream effector proteins, which consequently inhibits cytokine signaling for key pathways involved in inflammatory diseases 8.

Approved Indications

  • Upadacitinib is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis 8.
  • Clinical trials have demonstrated the superiority of upadacitinib treatment over placebo or an active comparator in these indications 8.

Mechanism of Action

  • Upadacitinib more potently inhibits JAK1 than other JAK isoforms, which may have implications for its efficacy and safety in various inflammatory diseases 8, 9.
  • The JAK-STAT pathway is involved in the pathogenesis of several chronic and progressive immune-mediated inflammatory diseases, including atopic dermatitis, psoriatic arthritis, and rheumatoid arthritis 9, 10.

Safety and Efficacy

  • The safety profile of upadacitinib supports a favorable benefit-risk profile across all approved indications 8.
  • Clinical trials have confirmed the efficacy and safety of upadacitinib in psoriatic arthritis and axial spondyloarthritis, with comparable safety to biologic DMARDs 10.
  • Upadacitinib has also shown promising results in the treatment of atopic dermatitis, with emerging data on its safety and efficacy 9.

Association with Other Diseases

  • Patients with atopic dermatitis have significantly increased odds of comorbid rheumatoid arthritis, but not vice versa 11.
  • There is limited evidence on the association between atopic dermatitis and other arthritic conditions, such as psoriatic arthritis, osteoarthritis, and juvenile idiopathic arthritis 11.

References

8
Research

Upadacitinib: Mechanism of action, clinical, and translational science.

Clinical and translational science, 2024

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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