Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study
ObjectiveThis study analyzes the occurrence and characteristics of adverse drug reactions (ADRs) of dupilumab in children in a real-world setting. It aims to enhance clinical practice and minimize medication safety risks in pediatric patients.MethodsThis prospective study included children receiving...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2024.1524962/full |
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| author | Yanhua Chen Jiang Ni Ming Li Yuan Hong Kouzhu Zhu Rong Hong Li Deng Zhijie Li Jie Pu Ting Yang Yan Wang |
| author_facet | Yanhua Chen Jiang Ni Ming Li Yuan Hong Kouzhu Zhu Rong Hong Li Deng Zhijie Li Jie Pu Ting Yang Yan Wang |
| author_sort | Yanhua Chen |
| collection | DOAJ |
| description | ObjectiveThis study analyzes the occurrence and characteristics of adverse drug reactions (ADRs) of dupilumab in children in a real-world setting. It aims to enhance clinical practice and minimize medication safety risks in pediatric patients.MethodsThis prospective study included children receiving dupilumab in the hospital between January 2022 and December 2023. Information on ADRs was collected and univariate and multivariate analyses were employed to identify high-risk factors for the occurrence of adverse effects in dupilumab treatment.ResultsA total of 65 ADRs occurred in 1,103 treatments in 127 patients, with an incidence of 27.56% (35/127). A total of 62 patients aged 6 or below participated in this study, accounting for 48.82%. Univariate analysis showed that gender, age, duration of medication, frequency of dupilumab use were risk factors for the occurrence of adverse effects (P < 0.05). Multivariate logistic regression analysis showed that age [odds ratio [OR]: 0.071, 95% confidence interval [CI]: 0.012–0.433; P = 0.004] and frequency of dupilumab use (OR: 3.306, 95% CI: 1.078–10.135; P = 0.036) were risk factors for adverse effects. The outcomes of ADRs were improved in 10 cases (15.38%) and completely recovered in 55 cases (84.62%).ConclusionDupilumab has a good safety profile in Chinese children aged 6 months to 18 years for up to 2 years of treatment, with most adverse reactions being mild to moderate, and no serious ocular adverse reactions were reported. Age and frequency of dupilumab use were risk factors for adverse effects. Younger age and higher frequency of dupilumab use were associated with higher odds of ADRs. |
| format | Article |
| id | doaj-art-b7d7b3f40afc401aa086b2ca5b1fffb2 |
| institution | Kabale University |
| issn | 2296-2360 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj-art-b7d7b3f40afc401aa086b2ca5b1fffb22025-01-17T06:50:40ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602025-01-011210.3389/fped.2024.15249621524962Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world studyYanhua Chen0Jiang Ni1Ming Li2Yuan Hong3Kouzhu Zhu4Rong Hong5Li Deng6Zhijie Li7Jie Pu8Ting Yang9Yan Wang10Department of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Pharmacy, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, ChinaCenter for ADR Monitoring of Jiangsu, Nanjing, Jiangsu, ChinaDepartment of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Dermatology, Affiliated Children’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Dermatology, Affiliated Children’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Dermatology, Affiliated Children’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaDepartment of Pharmacy, AffiliatedChildren’s Hospital of Jiangnan University (Wuxi Children’s Hospital), Wuxi, Jiangsu, ChinaObjectiveThis study analyzes the occurrence and characteristics of adverse drug reactions (ADRs) of dupilumab in children in a real-world setting. It aims to enhance clinical practice and minimize medication safety risks in pediatric patients.MethodsThis prospective study included children receiving dupilumab in the hospital between January 2022 and December 2023. Information on ADRs was collected and univariate and multivariate analyses were employed to identify high-risk factors for the occurrence of adverse effects in dupilumab treatment.ResultsA total of 65 ADRs occurred in 1,103 treatments in 127 patients, with an incidence of 27.56% (35/127). A total of 62 patients aged 6 or below participated in this study, accounting for 48.82%. Univariate analysis showed that gender, age, duration of medication, frequency of dupilumab use were risk factors for the occurrence of adverse effects (P < 0.05). Multivariate logistic regression analysis showed that age [odds ratio [OR]: 0.071, 95% confidence interval [CI]: 0.012–0.433; P = 0.004] and frequency of dupilumab use (OR: 3.306, 95% CI: 1.078–10.135; P = 0.036) were risk factors for adverse effects. The outcomes of ADRs were improved in 10 cases (15.38%) and completely recovered in 55 cases (84.62%).ConclusionDupilumab has a good safety profile in Chinese children aged 6 months to 18 years for up to 2 years of treatment, with most adverse reactions being mild to moderate, and no serious ocular adverse reactions were reported. Age and frequency of dupilumab use were risk factors for adverse effects. Younger age and higher frequency of dupilumab use were associated with higher odds of ADRs.https://www.frontiersin.org/articles/10.3389/fped.2024.1524962/fullchildrendupilumabreal worldsafetyadverse drug reactions |
| spellingShingle | Yanhua Chen Jiang Ni Ming Li Yuan Hong Kouzhu Zhu Rong Hong Li Deng Zhijie Li Jie Pu Ting Yang Yan Wang Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study Frontiers in Pediatrics children dupilumab real world safety adverse drug reactions |
| title | Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study |
| title_full | Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study |
| title_fullStr | Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study |
| title_full_unstemmed | Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study |
| title_short | Safety of dupilumab in Chinese pediatric patients aged 6 months and older: a prospective real-world study |
| title_sort | safety of dupilumab in chinese pediatric patients aged 6 months and older a prospective real world study |
| topic | children dupilumab real world safety adverse drug reactions |
| url | https://www.frontiersin.org/articles/10.3389/fped.2024.1524962/full |
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