What are the considerations for using ustekinumab (Stelara) in patients with thrombocytopenia (low platelet count)?

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Last updated: June 26, 2025View editorial policy

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From the Guidelines

Ustekinumab (Stelara) can be used in patients with mild to moderate thrombocytopenia, but caution is advised in severe cases, and the decision to use it should be based on individual patient risk assessment, considering the potential benefits and risks, as well as close monitoring of platelet counts 1. When considering the use of ustekinumab in patients with thrombocytopenia, it's essential to weigh the potential benefits against the risks. The medication's immunomodulatory effects, which block interleukin-12 and interleukin-23, could theoretically impact platelet counts, particularly in patients with autoimmune conditions causing thrombocytopenia.

Key Considerations

  • A complete blood count should be obtained as a baseline before initiating treatment with ustekinumab.
  • Regular monitoring of platelet counts is recommended during treatment, especially in patients with pre-existing thrombocytopenia.
  • The standard dosing regimen for ustekinumab varies by indication, with no specific dose adjustments recommended for thrombocytopenia alone, but clinical judgment should be used in severe cases.
  • If significant worsening of thrombocytopenia occurs during treatment, temporary interruption of therapy may be necessary while investigating other potential causes.

Guidance on Thrombocytopenia Management

According to the American Society of Clinical Oncology clinical practice guideline update from 2018, prophylactic platelet transfusion should be administered to patients with thrombocytopenia resulting from impaired bone marrow function to reduce the risk of hemorrhage when the platelet count falls below a predefined threshold level 1. This guideline suggests that the threshold level for transfusion varies according to the patient’s diagnosis, clinical condition, and treatment modality.

Clinical Decision Making

In clinical practice, the decision to use ustekinumab in patients with thrombocytopenia should be made on a case-by-case basis, taking into account the severity of the thrombocytopenia, the underlying cause, and the potential benefits and risks of treatment. Close monitoring and regular assessment of platelet counts are crucial to ensure safe use.

From the Research

Considerations for Using Ustekinumab in Patients with Thrombocytopenia

  • Ustekinumab (Stelara) is a medication used to treat various conditions, including psoriasis and Crohn's disease, by targeting specific components of the immune system 2.
  • Thrombocytopenia, or low platelet count, can be caused by various factors, including decreased platelet production, increased destruction, splenic sequestration, or dilution or clumping 2.
  • Patients with thrombocytopenia may experience bleeding complications, with the risk increasing as the platelet count decreases 3, 4.
  • The management of thrombocytopenia involves identifying the underlying cause, treating the condition, and preventing bleeding complications 2, 5.

Bleeding Risk and Platelet Count

  • Patients with platelet counts greater than 50 × 10^3 per μL are generally asymptomatic, while those with counts between 20 and 50 × 10^3 per μL may experience mild skin manifestations such as petechiae, purpura, or ecchymosis 2.
  • Patients with platelet counts of less than 10 × 10^3 per μL have a high risk of serious bleeding 2, 6.
  • The risk of bleeding can be assessed by considering the platelet count, clinical symptoms, and underlying cause of thrombocytopenia 5, 4.

Treatment and Platelet Transfusion

  • Treatment of thrombocytopenia may involve platelet transfusion, especially in patients with active hemorrhage or platelet counts less than 10 × 10^3 per μL 2, 6.
  • Platelet transfusion can help increase the platelet count and reduce the risk of bleeding, but it should be used judiciously and based on individual patient needs 6.
  • Ustekinumab has not been specifically studied in patients with thrombocytopenia, and its use in these patients should be carefully considered, taking into account the potential risks and benefits 2, 3, 5, 4, 6.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Thrombocytopenia: Evaluation and Management.

American family physician, 2022

Research

[Immune thrombocytopenia--pathophysiology and treatment].

Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 2010

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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