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Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept

Lihong Liu1, Zhenfei Chi2, Zhe Zhang3

  • 1Liaoning University of Traditional Chinese Medicine, The Third Affiliated Hospital of Jinzhou Medical University, Shenyang, China.

International Journal of Clinical Pharmacy
|July 2, 2025
PubMed
Abstract

Insights

Rilonacept (IL-1 trap) use shows potential adverse reactions in skin, immune, and cardiac systems. Further monitoring is crucial for patients using this interleukin-1 inhibitor.

Area of Science:

  • Pharmacovigilance
  • Immunology
  • Genetics

Background:

  • Rilonacept, an interleukin-1 (IL-1) inhibitor, is approved for recurrent pericarditis.
  • Limited data exists on rilonacept's adverse reactions due to its recent market introduction.

Purpose of the Study:

  • Identify potential adverse reactions of rilonacept using FDA Adverse Event Reporting System (FAERS) data.
  • Evaluate potential causal links between rilonacept and adverse events using Mendelian randomization (MR).

Main Methods:

  • Analyzed 419 FAERS reports (Jan 2021-June 2024) for rilonacept-associated adverse events.
  • Utilized disproportionality analyses (ROR, IC) to detect adverse reaction signals.
  • Conducted MR analysis with genetic variants to assess causality, including sensitivity analyses.

Main Results:

  • 1847 adverse events identified, with common occurrences including COVID-19 and injection site reactions.
  • Positive signals for adverse reactions were prominent in Immune System Disorders, Skin and Subcutaneous Tissue Disorders, and Cardiac Disorders.
  • MR analysis indicated associations between IL-1RN and allergic urticaria (OR: 1.56) and myocarditis (OR: 2.26).

Conclusions:

  • Rilonacept is effective for inflammatory conditions but requires vigilant monitoring.
  • Adverse reactions, especially those affecting the immune system, skin, and heart, warrant attention.
  • Pharmacovigilance and genetic analyses are vital for understanding drug safety profiles.
Keywords:
Adverse reactionsFAERSMendelian randomization analysisPharmacovigilanceRilonacept

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