Efficacy and safety of adalimumab in pediatric patients with Crohn’s disease: A systematic review and meta-analysis
Purpose There is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD. Materials and methods We searched all relevant studies in the PubMed, Web of Science, Embase, and Cochr...
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| Published in | European journal of clinical pharmacology Vol. 80; no. 3; pp. 395 - 407 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
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Berlin/Heidelberg
Springer Berlin Heidelberg
01.03.2024
Springer Nature B.V |
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| Abstract | Purpose
There is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.
Materials and methods
We searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool.
Results
Ten clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39–80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35–86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44–70%) achieved maintenance of remission, and 63% (95% CI 26–69%) achieved maintenance of response.
Conclusion
Current evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe.
Systematic review registration
https://www.crd.york.ac.uk/prospero/
, identifier CRD42023402199. |
|---|---|
| AbstractList | There is currently no curative treatment for childhood Crohn's disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.
We searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool.
Ten clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39-80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35-86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44-70%) achieved maintenance of remission, and 63% (95% CI 26-69%) achieved maintenance of response.
Current evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe.
https://www.crd.york.ac.uk/prospero/ , identifier CRD42023402199. There is currently no curative treatment for childhood Crohn's disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.PURPOSEThere is currently no curative treatment for childhood Crohn's disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.We searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool.MATERIALS AND METHODSWe searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool.Ten clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39-80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35-86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44-70%) achieved maintenance of remission, and 63% (95% CI 26-69%) achieved maintenance of response.RESULTSTen clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39-80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35-86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44-70%) achieved maintenance of remission, and 63% (95% CI 26-69%) achieved maintenance of response.Current evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe.CONCLUSIONCurrent evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe.https://www.crd.york.ac.uk/prospero/ , identifier CRD42023402199.SYSTEMATIC REVIEW REGISTRATIONhttps://www.crd.york.ac.uk/prospero/ , identifier CRD42023402199. PurposeThere is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD.Materials and methodsWe searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool.ResultsTen clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39–80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35–86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44–70%) achieved maintenance of remission, and 63% (95% CI 26–69%) achieved maintenance of response.ConclusionCurrent evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42023402199. Purpose There is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA) in pediatric patients with CD. Materials and methods We searched all relevant studies in the PubMed, Web of Science, Embase, and Cochrane Library databases. The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe adverse events and opportunistic infections to ADA. The Cochrane bias assessment tool was used to assess the risk of bias in randomized controlled trials. The methodological quality of the single-arm studies was assessed using the methodological index for non-randomized studies tool. Results Ten clinical trials involving a total of 885 patients were included. Results indicated that 59% (95% confidence interval [CI] 39–80%) of the subjects treated with ADA achieved induction of remission, and 60% (95% CI 35–86%) of the subjects treated with ADA achieved induction of response, 57% (95% CI 44–70%) achieved maintenance of remission, and 63% (95% CI 26–69%) achieved maintenance of response. Conclusion Current evidence indicates that ADA is effective in children and adolescents with CD and that adverse events vary but are usually not severe. Systematic review registration https://www.crd.york.ac.uk/prospero/ , identifier CRD42023402199. |
| Author | Zou, Zhuan Chen, Bin Zhang, Xiaoyan Xiao, Dongqiong Li, Xihong |
| Author_xml | – sequence: 1 givenname: Bin surname: Chen fullname: Chen, Bin organization: Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University – sequence: 2 givenname: Zhuan surname: Zou fullname: Zou, Zhuan organization: Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University – sequence: 3 givenname: Xiaoyan surname: Zhang fullname: Zhang, Xiaoyan organization: Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University – sequence: 4 givenname: Dongqiong surname: Xiao fullname: Xiao, Dongqiong organization: Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University – sequence: 5 givenname: Xihong surname: Li fullname: Li, Xihong email: lixihonghxey@163.com organization: Department of Pediatrics, West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University |
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| CitedBy_id | crossref_primary_10_1093_ibd_izae302 crossref_primary_10_1016_j_hipert_2024_11_002 |
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Gastroenterology 157(4):985-996.e982. https://doi.org/10.1053/j.gastro.2019.06.003 Alvisi P, Arrigo S, Cucchiara S, Lionetti P, Miele E, Romano C, Ravelli A, Knafelz D, Martelossi S, Guariso G, Accomando S, Zuin G, De Giacomo C, Balzani L, Gennari M, Aloi M (2019) Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn’s disease patients who failed infliximab therapy: the Italian Society of 3613_CR18 3613_CR19 JP Higgins (3613_CR20) 2011; 343 3613_CR30 3613_CR31 3613_CR14 3613_CR36 3613_CR15 3613_CR37 3613_CR16 3613_CR17 3613_CR10 3613_CR32 3613_CR11 3613_CR33 3613_CR12 3613_CR34 3613_CR13 3613_CR35 3613_CR29 3613_CR5 3613_CR6 3613_CR7 3613_CR8 3613_CR1 3613_CR2 3613_CR3 3613_CR4 K Slim (3613_CR21) 2003; 73 3613_CR9 3613_CR25 3613_CR26 3613_CR27 3613_CR28 3613_CR22 3613_CR23 3613_CR24 |
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There is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab... There is currently no curative treatment for childhood Crohn's disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab (ADA)... PurposeThere is currently no curative treatment for childhood Crohn’s disease (CD). This meta-analysis aimed to validate the efficacy and safety of adalimumab... |
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| SubjectTerms | Adalimumab - adverse effects Adalimumab - therapeutic use Adolescent Adverse events Biomedical and Life Sciences Biomedicine Child Children Clinical trials Crohn Disease - drug therapy Crohn's disease Humans Meta-analysis Monoclonal antibodies Patients Pediatrics Pharmacology/Toxicology Remission Remission (Medicine) Remission Induction Systematic review |
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| Title | Efficacy and safety of adalimumab in pediatric patients with Crohn’s disease: A systematic review and meta-analysis |
| URI | https://link.springer.com/article/10.1007/s00228-023-03613-1 https://www.ncbi.nlm.nih.gov/pubmed/38157000 https://www.proquest.com/docview/2927725048 https://www.proquest.com/docview/2909084247 https://pubmed.ncbi.nlm.nih.gov/PMC10873464 |
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