Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system
BackgroundAnakinra and canakinumab are two FDA-approved IL-1 blockers indicated for the treatment of multiple autoinflammatory diseases, yet their safety has not been comprehensively analyzed. We aimed to assess the safety signals associated with anakinra and canakinumab by conducting a pharmacovigi...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2025.1483669/full |
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| author | Hao Liu Wei Yan Jinsong Li Dezhi Yan Di Luo |
| author_facet | Hao Liu Wei Yan Jinsong Li Dezhi Yan Di Luo |
| author_sort | Hao Liu |
| collection | DOAJ |
| description | BackgroundAnakinra and canakinumab are two FDA-approved IL-1 blockers indicated for the treatment of multiple autoinflammatory diseases, yet their safety has not been comprehensively analyzed. We aimed to assess the safety signals associated with anakinra and canakinumab by conducting a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database.MethodsAdverse reaction data spanning from the first quarter of 2004 to the fourth quarter of 2023 was downloaded from the FAERS database. A disproportionality analysis utilizing various methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), was conducted.ResultsAnakinra and canakinumab were identified as the primary suspect drugs for adverse events (AEs) in 7,544 and 8,044 reports, respectively. The most commonly reported SOCs for both drugs were general disorders and administration site conditions. Subgroup analyses indicated that the most commonly reported SOC signals among health professionals and non-health professionals remained consistent across both medications. At the preferred term (PT) level, consistent with the drug labeling, the common AEs for anakinra and canakinumab included injection site reactions (ISRs) and infections. Further analysis revealed a higher frequency of ISRs with anakinra, including injection site pain and erythema. In contrast, canakinumab was associated with more gastrointestinal disorders (abdominal pain, mouth ulceration, and inflammatory bowel disease) and respiratory disorders (cough, oropharyngeal pain, and rhinorrhea); these conditions predominantly occurred among minors. Notably, no significant safety signals related to tuberculosis infection or reactivation were observed, and the frequency of AEs related to hepatic injury and malignancy was low.ConclusionThis study confirms the favorable safety profiles of anakinra and canakinumab, offering critical insights into rational drug usage and safety regulations. |
| format | Article |
| id | doaj-art-895a0ab4827c408281f8f819fcde9dca |
| institution | OA Journals |
| issn | 1663-9812 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj-art-895a0ab4827c408281f8f819fcde9dca2025-08-20T02:19:15ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122025-04-011610.3389/fphar.2025.14836691483669Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting systemHao Liu0Wei Yan1Jinsong Li2Dezhi Yan3Di Luo4The First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, ChinaOrthopedic Joint, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, ChinaOrthopedic Joint, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, ChinaThe First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, ChinaOrthopedic Joint, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, ChinaBackgroundAnakinra and canakinumab are two FDA-approved IL-1 blockers indicated for the treatment of multiple autoinflammatory diseases, yet their safety has not been comprehensively analyzed. We aimed to assess the safety signals associated with anakinra and canakinumab by conducting a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database.MethodsAdverse reaction data spanning from the first quarter of 2004 to the fourth quarter of 2023 was downloaded from the FAERS database. A disproportionality analysis utilizing various methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Empirical Bayes Geometric Mean (EBGM), was conducted.ResultsAnakinra and canakinumab were identified as the primary suspect drugs for adverse events (AEs) in 7,544 and 8,044 reports, respectively. The most commonly reported SOCs for both drugs were general disorders and administration site conditions. Subgroup analyses indicated that the most commonly reported SOC signals among health professionals and non-health professionals remained consistent across both medications. At the preferred term (PT) level, consistent with the drug labeling, the common AEs for anakinra and canakinumab included injection site reactions (ISRs) and infections. Further analysis revealed a higher frequency of ISRs with anakinra, including injection site pain and erythema. In contrast, canakinumab was associated with more gastrointestinal disorders (abdominal pain, mouth ulceration, and inflammatory bowel disease) and respiratory disorders (cough, oropharyngeal pain, and rhinorrhea); these conditions predominantly occurred among minors. Notably, no significant safety signals related to tuberculosis infection or reactivation were observed, and the frequency of AEs related to hepatic injury and malignancy was low.ConclusionThis study confirms the favorable safety profiles of anakinra and canakinumab, offering critical insights into rational drug usage and safety regulations.https://www.frontiersin.org/articles/10.3389/fphar.2025.1483669/fullanakinracanakinumabIL-1autoinflammatory diseasesFAERS databasereal-world data analysis |
| spellingShingle | Hao Liu Wei Yan Jinsong Li Dezhi Yan Di Luo Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system Frontiers in Pharmacology anakinra canakinumab IL-1 autoinflammatory diseases FAERS database real-world data analysis |
| title | Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system |
| title_full | Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system |
| title_fullStr | Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system |
| title_full_unstemmed | Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system |
| title_short | Post-marketing safety of anakinra and canakinumab: a real-world pharmacovigilance study based on FDA adverse event reporting system |
| title_sort | post marketing safety of anakinra and canakinumab a real world pharmacovigilance study based on fda adverse event reporting system |
| topic | anakinra canakinumab IL-1 autoinflammatory diseases FAERS database real-world data analysis |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2025.1483669/full |
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