What are the potential risks of starting fotofacitinib (Janus kinase inhibitor) in a patient with rheumatoid arthritis partially responding to methotrexate (MTX)?

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Last updated: June 16, 2025View editorial policy

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From the Guidelines

The patient should be counseled about the potential risk of deep venous thrombosis (DVT) when starting fotofacitinib, as Janus kinase inhibitors have been associated with an increased risk of venous thromboembolism (VTE), including DVT and pulmonary embolism, particularly in patients with a history of thromboembolic events or those with high risk factors for these events 1.

Key Points to Consider

  • The risk of VTE is elevated in patients with rheumatoid arthritis, and the use of JAK inhibitors may further increase this risk 1.
  • The incidence of VTEs has been shown to be dose-dependent, with higher doses of JAK inhibitors associated with a greater risk of VTEs 1.
  • Patients with a history of thromboembolic events, high body mass index, those with hormone replacement therapy, and higher age are at increased risk of VTEs when taking JAK inhibitors 1.
  • Regular monitoring and caution are advised when prescribing JAK inhibitors to patients with high risk factors for thromboembolic events 1.

Important Considerations for Patient Counseling

  • Patients should be informed about the potential risk of DVT and the importance of seeking medical attention immediately if symptoms occur.
  • Patients should be counseled about the signs and symptoms of DVT, such as leg swelling, redness, and warmth.
  • Patients should be advised to report any history of thromboembolic events or high risk factors for these events to their healthcare provider before starting fotofacitinib.

From the Research

Potential Risks of Starting Fotofacitinib

The patient is considering starting fotofacitinib, a Janus kinase inhibitor, for rheumatoid arthritis. The potential risks associated with this medication include:

  • Deep venous thrombosis (DVT) and pulmonary embolism (PE), as reported in studies 2, 3, 4
  • Increased risk of venous thromboembolism (VTE) in patients with rheumatoid arthritis, particularly those with uncontrolled disease activity and comorbidities 2, 5
  • Arterial thromboembolic events (ATE) have also been associated with JAK inhibitors, including baricitinib and tofacitinib 4

Risk Factors for Venous Thromboembolism

Several risk factors can contribute to the development of VTE, including:

  • Advanced age 2, 3
  • Obesity 2
  • Diabetes mellitus 2, 5
  • Hypertension 2
  • Hyperlipidemia 2
  • Smoking 2
  • Rheumatoid arthritis, particularly with uncontrolled disease activity and comorbidities 2, 5
  • Use of certain medications, such as warfarin, systemic corticosteroids, and potassium chloride 5

Counseling the Patient

When counseling the patient about the potential risks of starting fotofacitinib, it is essential to discuss the increased risk of DVT and PE, as well as the importance of monitoring for signs and symptoms of VTE and ATE. The patient should be advised to seek prompt medical attention if they experience any symptoms suggestive of VTE or ATE. The correct answer is A. Deep venous thrombosis.

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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