Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS
BackgroundThe advent of tisagenlecleucel has been a major advance in the pharmacological treatment of relapsed/refractory B-cell acute lymphoblastic leukemia in children and adolescents. However, further research is required to better define its safety profile.ObjectivesTo determine the cardiovascul...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1499143/full |
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| author | Ganggang Wang Lin Su Yanjun Liu Xiaohan Yang Yi Li Qi Mei Qi Mei Wen Gao |
| author_facet | Ganggang Wang Lin Su Yanjun Liu Xiaohan Yang Yi Li Qi Mei Qi Mei Wen Gao |
| author_sort | Ganggang Wang |
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| description | BackgroundThe advent of tisagenlecleucel has been a major advance in the pharmacological treatment of relapsed/refractory B-cell acute lymphoblastic leukemia in children and adolescents. However, further research is required to better define its safety profile.ObjectivesTo determine the cardiovascular toxicity of tisagenlecleucel in children and adolescents.MethodsThe US Food and Drug Administration’s Adverse Event Reporting System was searched to identify cardiovascular adverse events (CVAEs) related to tisagenlecleucel in pediatric patients up to the age of 18 years.ResultsThe median time to onset of tisagenlecleucel-associated CVAEs was shorter than that of tisagenlecleucel-associated non-CVAEs (3 days [interquartile range (IQR) 1, 6] vs. 7 days [IQR 2, 54]). The median time to onset was longer in patients with fatal CVAEs than in those with non-fatal CVAEs (4 days [IQR 1, 12.5] vs. 2 days [IQR 1, 4]). The most frequently reported CVAEs were mitral valve disease, hypotension, and capillary leak syndrome. Patients who developed shock had the highest mortality rate (66.67%). Concomitant use of medication for a neurological disorder was an independent risk factor for CVAEs, and concomitant use of medication for a respiratory disease was an independent risk factor for fatal CVAEs. Most CVAEs were associated with cytokine release syndrome, and older patients had a more favorable prognosis.ConclusionsChildren and adolescents who receive tisagenlecleucel should be closely monitored for CVAEs, particularly during the first week of treatment. |
| format | Article |
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| institution | Kabale University |
| issn | 1664-3224 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Immunology |
| spelling | doaj-art-f6dc1536f2fd4f9b9ec6f61b2db76c132025-01-22T07:15:21ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-01-011610.3389/fimmu.2025.14991431499143Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERSGanggang Wang0Lin Su1Yanjun Liu2Xiaohan Yang3Yi Li4Qi Mei5Qi Mei6Wen Gao7Department of Lymphatic Oncology, Cancer Center, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Third Hospital of Shanxi Medical University, Tongji Shanxi Hospital, Taiyuan, ChinaDepartment of Respiratory and Critical Care, Fourth People’s Hospital of Jinan City, Jinan, Shandong, ChinaDepartment of Cardiology, Fourth People’s Hospital of Jinan City, Jinan, Shandong, ChinaDepartment of Cardiology, Fourth People’s Hospital of Jinan City, Jinan, Shandong, ChinaDepartment of Cardiology, Fourth People’s Hospital of Jinan City, Jinan, Shandong, ChinaDepartment of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, ChinaCancer Center, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi, ChinaDepartment of Cardiology, Fourth People’s Hospital of Jinan City, Jinan, Shandong, ChinaBackgroundThe advent of tisagenlecleucel has been a major advance in the pharmacological treatment of relapsed/refractory B-cell acute lymphoblastic leukemia in children and adolescents. However, further research is required to better define its safety profile.ObjectivesTo determine the cardiovascular toxicity of tisagenlecleucel in children and adolescents.MethodsThe US Food and Drug Administration’s Adverse Event Reporting System was searched to identify cardiovascular adverse events (CVAEs) related to tisagenlecleucel in pediatric patients up to the age of 18 years.ResultsThe median time to onset of tisagenlecleucel-associated CVAEs was shorter than that of tisagenlecleucel-associated non-CVAEs (3 days [interquartile range (IQR) 1, 6] vs. 7 days [IQR 2, 54]). The median time to onset was longer in patients with fatal CVAEs than in those with non-fatal CVAEs (4 days [IQR 1, 12.5] vs. 2 days [IQR 1, 4]). The most frequently reported CVAEs were mitral valve disease, hypotension, and capillary leak syndrome. Patients who developed shock had the highest mortality rate (66.67%). Concomitant use of medication for a neurological disorder was an independent risk factor for CVAEs, and concomitant use of medication for a respiratory disease was an independent risk factor for fatal CVAEs. Most CVAEs were associated with cytokine release syndrome, and older patients had a more favorable prognosis.ConclusionsChildren and adolescents who receive tisagenlecleucel should be closely monitored for CVAEs, particularly during the first week of treatment.https://www.frontiersin.org/articles/10.3389/fimmu.2025.1499143/fulltisagenlecleucelAdverse Event Reporting Systemdata miningcardiovascular adverse eventchild |
| spellingShingle | Ganggang Wang Lin Su Yanjun Liu Xiaohan Yang Yi Li Qi Mei Qi Mei Wen Gao Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS Frontiers in Immunology tisagenlecleucel Adverse Event Reporting System data mining cardiovascular adverse event child |
| title | Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS |
| title_full | Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS |
| title_fullStr | Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS |
| title_full_unstemmed | Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS |
| title_short | Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS |
| title_sort | cardiovascular toxicity of tisagenlecleucel in children and adolescents analysis of spontaneous reports submitted to faers |
| topic | tisagenlecleucel Adverse Event Reporting System data mining cardiovascular adverse event child |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2025.1499143/full |
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