ArticleInternational journal of clinical pharmacy2026
Pharmacovigilance signal detection of rilonacept using FAERS with exploratory Mendelian randomization analysis.
Article in International journal of clinical pharmacy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionRilonacept, 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.
aimThis 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.
methodWe 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.
resultsA 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).
conclusionOur 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.
Indexed as
Identifiers
42821193What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.