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Peer-reviewedCC BY-NC-ND 4.0International Journal of Clinical Pharmacy

Pharmacovigilance signal detection of rilonacept using FAERS with exploratory Mendelian randomization analysis

  • Lihong Liu1,2
  • Zhenfei Chi2,3
  • Zhe Zhang1,4
4 affiliations
  1. 1Liaoning University of Traditional Chinese Medicine, Shenyang, China Liaoning
  2. 2The Third Affiliated Hospital of Jinzhou Medical University, Jinzhou, China Liaoning
  3. 3Shengjing Hospital affiliated to China Medical University, Liaoning Shenyang, China
  4. 4Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, Liaoning China
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Abstract

Introduction: Rilonacept, an interleukin-1 (IL-1) “trap,” is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction.

Aim: This study utilized FDA Adverse Event Reporting System (FAERS) to screen potential rilonacept-related adverse events, and further performed Mendelian randomization (MR) analysis to explore genetic associations related to IL-1 pathway modulation with these adverse events.

Method: We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and proportional reporting ratio (PRR). MR analysis was conducted using genetic variants of IL1RN as instrumental variables to explore associations between IL1RN genetic variation and identified adverse reactions, with sensitivity analyses performed for robustness.

Results: A total of 419 adverse event reports were analyzed, documenting 1847 adverse events (AEs). Common events include injection site erythema, injection site pain, and others, which are categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in General disorders and administration site conditions, Skin and subcutaneous tissue disorders, and Injury, poisoning and procedural complications. Disproportionality analysis identified positive signals primarily in Cardiac Disorders, and Immune System Disorders, with 4 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL1RN genetic variation (used to explore rilonacept-related effects) and allergic urticaria (OR: 1.56 1.08–2.26) and myocarditis (OR: 2.26 1.63–3.14).

Conclusion: Our study identified potential rilonacept AE signals via FAERS and IL1RN-genetic associations via MR (myocarditis was not detected in prior clinical trials). All findings serve solely to generate hypotheses for subsequent validation, and larger clinical datasets are needed to confirm these risks and optimize monitoring protocols.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11096-026-02212-1.

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Cite

BibTeXRIS
BibTeX
@article{liu2026pharmacovigilance,
  title = {{Pharmacovigilance signal detection of rilonacept using FAERS with exploratory Mendelian randomization analysis}},
  author = {Lihong Liu and Zhenfei Chi and Zhe Zhang},
  journal = {International Journal of Clinical Pharmacy},
  year = {2026},
  month = oct,
  doi = {10.1007/s11096-026-02212-1},
  url = {https://doi.org/10.1007/s11096-026-02212-1},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Pharmacovigilance signal detection of rilonacept using FAERS with exploratory Mendelian randomization analysis
AU  - Lihong Liu
AU  - Zhenfei Chi
AU  - Zhe Zhang
PY  - 2026
DA  - 2026/10/01
JO  - International Journal of Clinical Pharmacy
DO  - 10.1007/s11096-026-02212-1
UR  - https://doi.org/10.1007/s11096-026-02212-1
AB  - Introduction: Rilonacept, an interleukin-1 (IL-1) “trap,” is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction.  Aim: This study utilized FDA Adverse Event Reporting System (FAERS) to screen potential rilonacept-related adverse events, and further performed Mendelian randomization (MR) analysis to explore genetic associations related to IL-1 pathway modulation with these adverse events.  Method: We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and proportional reporting ratio (PRR). MR analysis was conducted using genetic variants of IL1RN as instrumental variables to explore associations between IL1RN genetic variation and identified adverse reactions, with sensitivity analyses performed for robustness.  Results: A total of 419 adverse event reports were analyzed, documenting 1847 adverse events (AEs). Common events include injection site erythema, injection site pain, and others, which are categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in General disorders and administration site conditions, Skin and subcutaneous tissue disorders, and Injury, poisoning and procedural complications. Disproportionality analysis identified positive signals primarily in Cardiac Disorders, and Immune System Disorders, with 4 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL1RN genetic variation (used to explore rilonacept-related effects) and allergic urticaria (OR: 1.56 1.08–2.26) and myocarditis (OR: 2.26 1.63–3.14).  Conclusion: Our study identified potential rilonacept AE signals via FAERS and IL1RN-genetic associations via MR (myocarditis was not detected in prior clinical trials). All findings serve solely to generate hypotheses for subsequent validation, and larger clinical datasets are needed to confirm these risks and optimize monitoring protocols.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s11096-026-02212-1.
SN  - 2210-7703
SN  - 2210-7711
ER  -