Pharmacovigilance analysis of FcRn antagonists in the treatment of myasthenia gravis: A disproportionality analysis based on the FAERS database
<p>This study aimed to evaluate the safety profiles of FcRn antagonists, efgartigimod alfa and rozanolixizumab, in the treatment of myasthenia gravis using real-world adverse event data from the FAERS database. A disproportionality analysis was conducted employing Reporting Odds Ratio (ROR) an...
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2025
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| Summary: | <p>This study aimed to evaluate the safety profiles of FcRn antagonists, efgartigimod alfa and rozanolixizumab, in the treatment of myasthenia gravis using real-world adverse event data from the FAERS database. A disproportionality analysis was conducted employing Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) methods on reports from Q1 2022 to Q2 2025. The most frequently reported adverse events for efgartigimod alfa included falls, urinary tract infections, and symptom recurrence, with signals also detected for atrial fibrillation, peripheral neuropathy, and prostate cancer. For rozanolixizumab, common events were headache, diarrhea, and vomiting, with potential signals such as meningitis, hypersomnia, and feeding disorder. Subgroup analysis revealed gender-specific differences in adverse reactions. Most events occurred within 30 days of treatment initiation, though efgartigimod alfa showed a sustained risk beyond 180 days. The study identifies novel safety signals and highlights clinically relevant risk patterns, supporting enhanced monitoring in clinical use. It is crucial to emphasize that this disproportionality analysis is exploratory in nature and identifies potential associations, which do not establish causality and require confirmation through further dedicated studies.</p> |
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