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<p>Sotatercept (brand name “Winrevair”) is a novel activin receptor type IIA (ActRIIA) fusion protein. Sotatercept has received FDA approval for WHO Gloup 1 pulmonary arterial hypertension (PAH) in 2023. While clinical trials demonstrated efficacy, comprehensive real-world safety data are lacking. Food and Drug Adverse Event Reporting System (FAERS) reports from Q1 2024 to Q1 2025 involving Sotatercept were analyzed. After data cleaning and standardization using MedDRA v27.1, reports where Sotatercept was the primary suspect drug (PS) were identified. Disproportionality analysis employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time analysis was performed. Among 2748 eligible reports, 72.8% involved females, predominantly aged 16-64.9 years. The most frequent System Organ Classes (SOCs) were general disorders and administration site condition (19.29%), gastrointestinal disorders (13.8%), and investigations (13.4%). The first 30 adverse events (AEs) mainly included headache (<i>n</i> = 124), epistaxis (<i>n</i> = 88), hemoglobin increased (<i>n</i> = 81), dizziness (<i>n</i> = 61), and platelet count decreased (<i>n</i> = 42). AEs can still occur after one year of use. This large-scale FAERS analysis identifies signals consistent with known AEs observed during Sotatercept use and identifies novel potential serious safety signals: pulmonary arteriovenous fistula and pericardial effusion. Enhanced monitoring is required, especially of hematologic parameters, bleeding risk, and cardiopulmonary complications during initial treatment. Further investigation into these signals’ mechanisms is needed.</p>

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Pharmacovigilance Analysis of Sotatercept for the Treatment of Pulmonary Arterial Hypertension Based on FAERS Database

  • 期刊论文

  • 发表日期：

    2026年1月9日

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  • Yaxin Zhang,
  • Jing Ye,
  • Jinming Chen,
  • Jianuo Chen,
  • Yinxia Wu,
  • Jie Yang,
  • Xiaoyan Wu

摘要

Sotatercept (brand name “Winrevair”) is a novel activin receptor type IIA (ActRIIA) fusion protein. Sotatercept has received FDA approval for WHO Gloup 1 pulmonary arterial hypertension (PAH) in 2023. While clinical trials demonstrated efficacy, comprehensive real-world safety data are lacking. Food and Drug Adverse Event Reporting System (FAERS) reports from Q1 2024 to Q1 2025 involving Sotatercept were analyzed. After data cleaning and standardization using MedDRA v27.1, reports where Sotatercept was the primary suspect drug (PS) were identified. Disproportionality analysis employed four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time analysis was performed. Among 2748 eligible reports, 72.8% involved females, predominantly aged 16-64.9 years. The most frequent System Organ Classes (SOCs) were general disorders and administration site condition (19.29%), gastrointestinal disorders (13.8%), and investigations (13.4%). The first 30 adverse events (AEs) mainly included headache (n = 124), epistaxis (n = 88), hemoglobin increased (n = 81), dizziness (n = 61), and platelet count decreased (n = 42). AEs can still occur after one year of use. This large-scale FAERS analysis identifies signals consistent with known AEs observed during Sotatercept use and identifies novel potential serious safety signals: pulmonary arteriovenous fistula and pericardial effusion. Enhanced monitoring is required, especially of hematologic parameters, bleeding risk, and cardiopulmonary complications during initial treatment. Further investigation into these signals’ mechanisms is needed.