Integrated Exposure–Response of Dupilumab in Children, Adolescents, and Adults With Atopic Dermatitis Using Categorical and Continuous Efficacy Assessments: A Population Analysis

Integrated Exposure–Response of Dupilumab in Children, Adolescents, and Adults With Atopic Dermatitis Using Categorical and Continuous Efficacy Assessments: A Population Analysis

Background While the majority of patients with atopic dermatitis (AD) achieve disease control with dupilumab treatment, there is variability in which patients achieve clear disease. The predictors of these responses are currently unclear. Integrated models were developed to evaluate the exposure–res...

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Veröffentlicht in:Pharmaceutical research 2023-11, Vol.40 (11), p.2653-2666
Hauptverfasser: Briggs, Emily, Kamal, Mohamed A., Kosloski, Matthew P., Linsmeier, Ian, Jusko, Natalie, Dolphin, Nancy, Chittenden, Jason, Simpson, Eric L., Paller, Amy S., Siegfried, Elaine C., Shumel, Brad, Levit, Noah A., Bansal, Ashish, Davis, John D., Chapel, Sunny, Smith, David E., Huniti, Nidal
Format: Artikel
Sprache:eng
Schlagworte:
Adolescent
Adolescents
Adult
Advertising executives
Age groups
Analysis
Atopic dermatitis
Biochemistry
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Body weight
Care and treatment
CCL17 protein
Chemokines
Child
Children
Clinical trials
Dermatitis
Dermatitis, Atopic - drug therapy
Disease control
Double-Blind Method
Eczema
Humans
Immunoglobulin A
Immunoglobulin A - therapeutic use
Injections, Subcutaneous
Medical colleges
Medical Law
Medical research
Medicine, Experimental
Monoclonal antibodies
Original
Original Research Article
Patients
Pharmacology/Toxicology
Pharmacy
Placebos
Population studies
Severity of Illness Index
Simulation methods
Teenagers
Thymus
Treatment Outcome
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Zusammenfassung:Background While the majority of patients with atopic dermatitis (AD) achieve disease control with dupilumab treatment, there is variability in which patients achieve clear disease. The predictors of these responses are currently unclear. Integrated models were developed to evaluate the exposure–response (E-R) relationship of dupilumab in children, adolescents, and adults with AD. Methods Data from six Phase II and III clinical studies were pooled (2,366 adults [> 18 years], 243 adolescents [≥ 12 to 
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-023-03616-8