| アブストラクト | Cytoreductive therapies remain vital to the management of polycythemia vera (PV). Real-world data are needed to complement clinical trial safety information. We evaluated the safety profiles of four commonly used PV therapies-ropeginterferon alfa-2b (ropeg, on-label), peginterferon alfa-2a (peg-IFN, off-label), ruxolitinib (on-label), and hydroxyurea (HU, off-label)-using the FDA Adverse Event Reporting System (FAERS) database. Among 97,812 adverse event (AE) reports for patients receiving cytoreduction from January 1, 2022, through December 31, 2024, 11,754 were analyzed. HU and peg-IFN showed elevated reporting odds ratios (RORs) for serious adverse events (SAEs), which increased over time for HU (8.55 in 2022, 13.46 in 2023, 16.04 in 2024) and peaked for peg-IFN in 2023 (22.25). Ruxolitinib had ROR > 1 only in 2023 (1.47), while ropeg had no RORs > 1 for SAEs. For fatal AEs, ruxolitinib demonstrated RORs > 1 across multiple years (15.74 in 2022, 5.07 in 2023, 4.47 in 2024), whereas HU, peg-IFN, and ropeg did not. HU and ruxolitinib were associated with higher reporting of blood and lymphatic disorders than ropeg and peg-IFN, while peg-IFN had the highest proportion of cardiac disorder AEs (4.38%). HU (8.24%) and ruxolitinib (2.79%) showed elevated neoplasm-related AE proportions compared with peg-IFN (1.46%) and ropeg (0.65%). Ropeg showed the highest RORs for non-serious AEs. Contrary to clinical trial data, psychiatric disorders were most reported with ropeg (5.79%). An exploratory age-stratified analysis was also performed, though interpretation was limited by missing age data. These real-world findings provide valuable insights into the long-term risk-benefit profiles of cytoreductive therapies in PV and can guide personalized treatment strategies. Further studies are warranted to confirm these observations. |
|---|
| 投稿者 | Reeves, Brandi N; Masarova, Lucia; Abu-Zeinah, Ghaith; Hunter, Anthony M; Shatzel, Joseph J; Qin, Albert; Yoon, Chang Ho; Cai, Ling-Yu; Wei, Yu-Feng; Mesa, Ruben A |
|---|
| 組織名 | Division of Hematology, Department of Medicine, Blood Research Center, Lineberger;Comprehensive Cancer Center, The University of North Carolina at Chapel Hill,;Chapel Hill, NC, USA. brandi_reeves@med.unc.edu.;Department of Leukemia, Division of Cancer Medicine, The University of Texas MD;Anderson Cancer Center, Houston, TX, USA.;Division of Hematology and Medical Oncology, Weill Cornell Medicine, New York,;NY, USA.;Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory;University, Atlanta, GA, USA.;Division of Hematology and Medical Oncology, Oregon Health and Science,;University Knight Cancer Institute, Portland, OR, USA.;PharmaEssentia Corporation, Taipei, Taiwan.;John Radcliffe Hospital, Oxford University Hospitals NHS Trust, Headley Way,;Headington, Oxford, OX39DU, UK.;Vizuro LLC, Boston, MA, USA.;Levine Cancer Institute, Cancer Programs, Atrium Health, Wake Forest University;School of Medicine, Charlotte, NC, USA. |
|---|
