This pharmacovigilance study used VigiBase to identify immunomodulators associated with reporting of atrial fibrillation (AF). A disproportionality analysis estimated multivariable-adjusted reporting odds ratios (aROR) for AF across 141 immunomodulators, using over 6 million reports.
The primary analysis identified 20 immunomodulators with AF over-reporting signals, with the strongest signals for recombinant interleukin-11 (aROR 20.91; 99.96% CI 12.08–36.17), efgartigimod alfa (aROR 6.75; 99.96% CI 3.96–11.52), and recombinant interleukin-2 (aROR 6.15; 99.96% CI 3.62–10.45). Indication bias was addressed by including treatment indications in the multivariable model; however, authors acknowledge potential information bias from misclassification of AF and the observational nature of pharmacovigilance data.
A narrative literature review proposed a hypothetical immune-driven “vicious circle” involving T helper cells, macrophages, and natural killer cells contributing to atrial remodeling. The authors emphasize uncertainty due to reliance on spontaneous reports and advocate prospective studies to refine safety signals and explore mechanistic connections between immunomodulation and AF.
BMJ Open published a clinical update in Research Highlights on 07 Apr 2026.
The item focuses on Identification of immunomodulators associated with atrial fibrillation reporting to better understand AF immunologic mechanisms: a Vigibase retrospective disproportionality analysis and a literature review.
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