Exploring Novel Adverse Events of Nefecon
Introduction: Nefecon, the first innovative drug approved by both the US Food and Drug Administration (FDA) and European Medicines Agency for IgA nephropathy (IgAN), lacked comprehensive real-world assessments of its adverse events (AEs). Methods: We leveraged postmarketing data of Nefecon from the...
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Elsevier
2024-09-01
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| Series: | Kidney International Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024924018229 |
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| author | Jingyu Wang Zhao Zhang Xingzi Liu Sufang Shi Jicheng Lv Yuemiao Zhang Hong Zhang |
| author_facet | Jingyu Wang Zhao Zhang Xingzi Liu Sufang Shi Jicheng Lv Yuemiao Zhang Hong Zhang |
| author_sort | Jingyu Wang |
| collection | DOAJ |
| description | Introduction: Nefecon, the first innovative drug approved by both the US Food and Drug Administration (FDA) and European Medicines Agency for IgA nephropathy (IgAN), lacked comprehensive real-world assessments of its adverse events (AEs). Methods: We leveraged postmarketing data of Nefecon from the US FDA Adverse Event Reporting System (FAERS), employing disproportionate analysis (DPA) to detect positive signals at the system organ class (SOC) and preferred terms (PTs) levels. Duplicate AEs related to budesonide and those previously reported in studies were excluded through the use of the Medical Dictionary of Regulatory Activities (MedDRA). Our analysis encompassed time-to-onset (TTO), Weibull shape parameter (WSP) evaluation, cumulative incidence, clinical prioritization evaluation, and subgroup analysis based on gender and age. Results: A total of 1515 individuals with IgAN were included. Five positive SOC signals and 23 positive PT signals were identified, including 4 PTs (asthenia, malaise, product dose omission issue, and anxiety) representing novel AEs newly identified in this study. None of the positive PTs were classified as high clinical priority, with only acne, hypertension, swelling face, and weight increased considered as moderate clinical priority events. The median time to TTO was 31 days. All WSP test results indicated an early failure type profile. Lastly, subgroup analysis provided further insights into the relative risk of specific AEs. Conclusion: Nefecon demonstrates a favorable safety profile, with no high-priority clinical events identified. The identification of novel AEs and subgroup-specific relative high-risk events fills a gap in existing studies and offers valuable insights for early clinical vigilance. |
| format | Article |
| id | doaj-art-60a85897d3df4facb463d6c16a55929c |
| institution | DOAJ |
| issn | 2468-0249 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj-art-60a85897d3df4facb463d6c16a55929c2025-08-20T03:21:11ZengElsevierKidney International Reports2468-02492024-09-01992705271710.1016/j.ekir.2024.07.006Exploring Novel Adverse Events of NefeconJingyu Wang0Zhao Zhang1Xingzi Liu2Sufang Shi3Jicheng Lv4Yuemiao Zhang5Hong Zhang6Renal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaRenal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaRenal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaRenal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaRenal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaRenal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, China; Correspondence: Yuemiao Zhang, Renal Division, Peking University First Hospital, Xishiku Street No. 8, Xicheng District, Beijing 100034, China.Renal Division, Peking University First Hospital, Beijing, China; Peking University Institute of Nephrology, Beijing, China; Key Laboratory of Renal Disease, Ministry of Health of China, Beijing, China; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Peking University, Ministry of Education, Beijing, China; Research Units of Diagnosis and Treatment of Immune-mediated Kidney Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaIntroduction: Nefecon, the first innovative drug approved by both the US Food and Drug Administration (FDA) and European Medicines Agency for IgA nephropathy (IgAN), lacked comprehensive real-world assessments of its adverse events (AEs). Methods: We leveraged postmarketing data of Nefecon from the US FDA Adverse Event Reporting System (FAERS), employing disproportionate analysis (DPA) to detect positive signals at the system organ class (SOC) and preferred terms (PTs) levels. Duplicate AEs related to budesonide and those previously reported in studies were excluded through the use of the Medical Dictionary of Regulatory Activities (MedDRA). Our analysis encompassed time-to-onset (TTO), Weibull shape parameter (WSP) evaluation, cumulative incidence, clinical prioritization evaluation, and subgroup analysis based on gender and age. Results: A total of 1515 individuals with IgAN were included. Five positive SOC signals and 23 positive PT signals were identified, including 4 PTs (asthenia, malaise, product dose omission issue, and anxiety) representing novel AEs newly identified in this study. None of the positive PTs were classified as high clinical priority, with only acne, hypertension, swelling face, and weight increased considered as moderate clinical priority events. The median time to TTO was 31 days. All WSP test results indicated an early failure type profile. Lastly, subgroup analysis provided further insights into the relative risk of specific AEs. Conclusion: Nefecon demonstrates a favorable safety profile, with no high-priority clinical events identified. The identification of novel AEs and subgroup-specific relative high-risk events fills a gap in existing studies and offers valuable insights for early clinical vigilance.http://www.sciencedirect.com/science/article/pii/S2468024924018229adverse eventsbudesonideFAERSIgA nephropathyNefeconpharmacovigilance |
| spellingShingle | Jingyu Wang Zhao Zhang Xingzi Liu Sufang Shi Jicheng Lv Yuemiao Zhang Hong Zhang Exploring Novel Adverse Events of Nefecon Kidney International Reports adverse events budesonide FAERS IgA nephropathy Nefecon pharmacovigilance |
| title | Exploring Novel Adverse Events of Nefecon |
| title_full | Exploring Novel Adverse Events of Nefecon |
| title_fullStr | Exploring Novel Adverse Events of Nefecon |
| title_full_unstemmed | Exploring Novel Adverse Events of Nefecon |
| title_short | Exploring Novel Adverse Events of Nefecon |
| title_sort | exploring novel adverse events of nefecon |
| topic | adverse events budesonide FAERS IgA nephropathy Nefecon pharmacovigilance |
| url | http://www.sciencedirect.com/science/article/pii/S2468024924018229 |
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