A pharmacovigilance analysis of post-marketing safety of durvalumab
Abstract Durvalumab has demonstrated significant efficacy in several types of malignancies, while large-scale real-world safety studies remain limited. This study aimed to systematically evaluate the safety of durvalumab through data mining of the U.S. Food and Drug Administration Adverse Event Repo...
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Nature Portfolio
2025-05-01
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| Online Access: | https://doi.org/10.1038/s41598-025-01583-1 |
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| author | An-Ju Tan Wan-Ying Liu Jun-Li Lu Qing-Ying Tan Yu Yan Dun-Chang Mo |
| author_facet | An-Ju Tan Wan-Ying Liu Jun-Li Lu Qing-Ying Tan Yu Yan Dun-Chang Mo |
| author_sort | An-Ju Tan |
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| description | Abstract Durvalumab has demonstrated significant efficacy in several types of malignancies, while large-scale real-world safety studies remain limited. This study aimed to systematically evaluate the safety of durvalumab through data mining of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We extracted reports of durvalumab as the primary suspected drug from the FAERS database (January 2017 to June 2024). Four disproportionality analysis algorithms were used to detect signals between durvalumab and adverse events (AEs). Durvalumab was recorded in 10,120 reports as the primary suspected drug. Of these, 43.6% of AEs occurred during the first month of treatment, with a median onset time of 40 days (IQR: 14–99 ). Among 181 potential signals, 64 were unexpected preferred terms not listed in the prescribing information, including cytokine release syndrome (CRS), pulmonary tuberculosis, radiation esophagitis, oesophageal fistula, oesophageal perforation, pleural effusion, pneumothorax, cerebral infarction, biliary tract infection, cholecystitis, psoriasiform dermatitis, portal vein thrombosis, acute cholangitis and pericarditis malignant. Serious adverse events accounted for 93.3% of cases. Males exhibited a significantly higher risk of experiencing serious outcomes compared to females (OR = 1.83, 95% CI: 1.52–2.19, P < 0.001). Older age groups demonstrated an elevated risk of severe outcomes relative to those under 65 years (65–74 years: OR = 1.52, 95% CI: 1.15-2.00, P = 0.003; ≥75 years: OR = 1.40, 95% CI: 1.02–1.92, P = 0.038). This study comprehensively assessed the safety of durvalumab and discovered potential new adverse event signals, which may provide critical support for risk identification and monitoring of durvalumab. |
| format | Article |
| id | doaj-art-aad34f082bd0419c81fa76f1f0b56b7e |
| institution | DOAJ |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Nature Portfolio |
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| series | Scientific Reports |
| spelling | doaj-art-aad34f082bd0419c81fa76f1f0b56b7e2025-08-20T03:10:17ZengNature PortfolioScientific Reports2045-23222025-05-0115111110.1038/s41598-025-01583-1A pharmacovigilance analysis of post-marketing safety of durvalumabAn-Ju Tan0Wan-Ying Liu1Jun-Li Lu2Qing-Ying Tan3Yu Yan4Dun-Chang Mo5Office of Drug Clinical Trials Institutions, The Third Affiliated Hospital of Guangxi Medical UniversityOffice of Drug Clinical Trials Institutions, The Third Affiliated Hospital of Guangxi Medical UniversityOffice of Drug Clinical Trials Institutions, The Third Affiliated Hospital of Guangxi Medical UniversityReproductive Medical Center, The Third Affiliated Hospital of Guangxi Medical UniversityOffice of Drug Clinical Trials Institutions, The Third Affiliated Hospital of Guangxi Medical UniversityDepartment of Tumor Radiotherapy, The Third Affiliated Hospital of Guangxi Medical UniversityAbstract Durvalumab has demonstrated significant efficacy in several types of malignancies, while large-scale real-world safety studies remain limited. This study aimed to systematically evaluate the safety of durvalumab through data mining of the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). We extracted reports of durvalumab as the primary suspected drug from the FAERS database (January 2017 to June 2024). Four disproportionality analysis algorithms were used to detect signals between durvalumab and adverse events (AEs). Durvalumab was recorded in 10,120 reports as the primary suspected drug. Of these, 43.6% of AEs occurred during the first month of treatment, with a median onset time of 40 days (IQR: 14–99 ). Among 181 potential signals, 64 were unexpected preferred terms not listed in the prescribing information, including cytokine release syndrome (CRS), pulmonary tuberculosis, radiation esophagitis, oesophageal fistula, oesophageal perforation, pleural effusion, pneumothorax, cerebral infarction, biliary tract infection, cholecystitis, psoriasiform dermatitis, portal vein thrombosis, acute cholangitis and pericarditis malignant. Serious adverse events accounted for 93.3% of cases. Males exhibited a significantly higher risk of experiencing serious outcomes compared to females (OR = 1.83, 95% CI: 1.52–2.19, P < 0.001). Older age groups demonstrated an elevated risk of severe outcomes relative to those under 65 years (65–74 years: OR = 1.52, 95% CI: 1.15-2.00, P = 0.003; ≥75 years: OR = 1.40, 95% CI: 1.02–1.92, P = 0.038). This study comprehensively assessed the safety of durvalumab and discovered potential new adverse event signals, which may provide critical support for risk identification and monitoring of durvalumab.https://doi.org/10.1038/s41598-025-01583-1Adverse eventsFAERSPharmacovigilanceDurvalumabCytokine-release syndromePulmonary tuberculosis |
| spellingShingle | An-Ju Tan Wan-Ying Liu Jun-Li Lu Qing-Ying Tan Yu Yan Dun-Chang Mo A pharmacovigilance analysis of post-marketing safety of durvalumab Scientific Reports Adverse events FAERS Pharmacovigilance Durvalumab Cytokine-release syndrome Pulmonary tuberculosis |
| title | A pharmacovigilance analysis of post-marketing safety of durvalumab |
| title_full | A pharmacovigilance analysis of post-marketing safety of durvalumab |
| title_fullStr | A pharmacovigilance analysis of post-marketing safety of durvalumab |
| title_full_unstemmed | A pharmacovigilance analysis of post-marketing safety of durvalumab |
| title_short | A pharmacovigilance analysis of post-marketing safety of durvalumab |
| title_sort | pharmacovigilance analysis of post marketing safety of durvalumab |
| topic | Adverse events FAERS Pharmacovigilance Durvalumab Cytokine-release syndrome Pulmonary tuberculosis |
| url | https://doi.org/10.1038/s41598-025-01583-1 |
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