Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database
Background Proteasome inhibitors (PIs) such as Bortezomib, Carfilzomib, and Ixazomib have significantly improved outcomes in multiple myeloma (MM), but their real-world safety profiles require further exploration.Objective To assess adverse drug events (ADEs) associated with Bortezomib, Carfilzomib,...
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| Format: | Article |
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Taylor & Francis Group
2025-12-01
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| Series: | Hematology |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/16078454.2025.2534758 |
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| author | JunYun Luo Shupeng Chen Meiling Zhang Yao Gao Yingjian Zeng |
| author_facet | JunYun Luo Shupeng Chen Meiling Zhang Yao Gao Yingjian Zeng |
| author_sort | JunYun Luo |
| collection | DOAJ |
| description | Background Proteasome inhibitors (PIs) such as Bortezomib, Carfilzomib, and Ixazomib have significantly improved outcomes in multiple myeloma (MM), but their real-world safety profiles require further exploration.Objective To assess adverse drug events (ADEs) associated with Bortezomib, Carfilzomib, and Ixazomib in MM patients using the FDA Adverse Event Reporting System (FAERS), and to identify new ADE signals not listed in product labels.Methods A total of 47,310 ADE reports (Bortezomib: 23,843; Carfilzomib: 9,835; Ixazomib: 13,632) were analyzed from FAERS (2004 – Q4 2024). Signal detection was conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time was evaluated using Weibull survival analysis.Results All three PIs were associated with significant ADE signals across multiple system organ classes, notably in the hematologic, nervous, cardiovascular, hepatobiliary, and gastrointestinal systems. Newly identified ADEs included muscular weakness (Bortezomib), pancytopenia (Carfilzomib), and cognitive disorder (Ixazomib). Onset time analysis showed that most ADEs occurred within the first 30 days of treatment.Conclusion This study highlights both known and newly detected ADEs linked to PIs, emphasizing the importance of early-phase monitoring and ongoing pharmacovigilance. The findings provide crucial real-world evidence for clinical risk management and future label updates. |
| format | Article |
| id | doaj-art-ee5d7169daf841978dfa7f78be52bdfe |
| institution | Kabale University |
| issn | 1607-8454 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Hematology |
| spelling | doaj-art-ee5d7169daf841978dfa7f78be52bdfe2025-08-20T03:51:30ZengTaylor & Francis GroupHematology1607-84542025-12-0130110.1080/16078454.2025.2534758Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS databaseJunYun Luo0Shupeng Chen1Meiling Zhang2Yao Gao3Yingjian Zeng4School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People’s Republic of ChinaSchool of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People’s Republic of ChinaSchool of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People’s Republic of ChinaSchool of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, People’s Republic of ChinaAffiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang, People’s Republic of ChinaBackground Proteasome inhibitors (PIs) such as Bortezomib, Carfilzomib, and Ixazomib have significantly improved outcomes in multiple myeloma (MM), but their real-world safety profiles require further exploration.Objective To assess adverse drug events (ADEs) associated with Bortezomib, Carfilzomib, and Ixazomib in MM patients using the FDA Adverse Event Reporting System (FAERS), and to identify new ADE signals not listed in product labels.Methods A total of 47,310 ADE reports (Bortezomib: 23,843; Carfilzomib: 9,835; Ixazomib: 13,632) were analyzed from FAERS (2004 – Q4 2024). Signal detection was conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Onset time was evaluated using Weibull survival analysis.Results All three PIs were associated with significant ADE signals across multiple system organ classes, notably in the hematologic, nervous, cardiovascular, hepatobiliary, and gastrointestinal systems. Newly identified ADEs included muscular weakness (Bortezomib), pancytopenia (Carfilzomib), and cognitive disorder (Ixazomib). Onset time analysis showed that most ADEs occurred within the first 30 days of treatment.Conclusion This study highlights both known and newly detected ADEs linked to PIs, emphasizing the importance of early-phase monitoring and ongoing pharmacovigilance. The findings provide crucial real-world evidence for clinical risk management and future label updates.https://www.tandfonline.com/doi/10.1080/16078454.2025.2534758Multiple myelomaproteasome inhibitorsadverse drug eventsFAERSPharmacovigilanceonset time |
| spellingShingle | JunYun Luo Shupeng Chen Meiling Zhang Yao Gao Yingjian Zeng Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database Hematology Multiple myeloma proteasome inhibitors adverse drug events FAERS Pharmacovigilance onset time |
| title | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database |
| title_full | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database |
| title_fullStr | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database |
| title_full_unstemmed | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database |
| title_short | Pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma: a real-world analysis using the FAERS database |
| title_sort | pharmacovigilance and signal detection of adverse drug events associated with proteasome inhibitors in multiple myeloma a real world analysis using the faers database |
| topic | Multiple myeloma proteasome inhibitors adverse drug events FAERS Pharmacovigilance onset time |
| url | https://www.tandfonline.com/doi/10.1080/16078454.2025.2534758 |
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