ArticleClinical pharmacology in drug development2020
Base and Covariate Population Pharmacokinetic Analyses of Dupilumab Using Phase 3 Data.
Article in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma.CPT: pharmacometrics & systems pharmacology · 2021Pooled it
- Population Pharmacokinetics of Dupilumab in Adults, Adolescents, and Children With Eosinophilic Esophagitis.Clinical pharmacology and therapeutics · 2026Trial
- Semi-Mechanistic Population Pharmacokinetic/Pharmacodynamic (PK/PD) Modeling of Dupilumab on Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEVCPT: pharmacometrics & systems pharmacology · 2025Trial
- Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis.Clinical and translational science · 2022Trial
- Pharmacokinetics and Concentration-Response of Dupilumab in Patients With Seasonal Allergic Rhinitis.Journal of clinical pharmacology · 2022Trial
- The Posology of Dupilumab in Pediatric Patients With Atopic Dermatitis.Clinical pharmacology and therapeutics · 2021Trial
- A phase 2, open-label study of single-dose dupilumab in children aged 6 months to <6 years with severe uncontrolled atopic dermatitis: pharmacokinetics, safety and efficacy.Journal of the European Academy of Dermatology and Venereology : JEADV · 2021Trial
- Assessing Covariate Clinical Relevance in High-Dimensional PK Analysis: A Comparison of SCM+, FFEM, and FREM Approaches.CPT: pharmacometrics & systems pharmacology · 2026Article
- Target-Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data.Clinical pharmacology in drug development · 2025Article
- Appropriate Injection Intervals of Dupilumab in Patients With Adult Atopic Dermatitis: A Step Toward Developing Guidelines for Daily Practice.Annals of dermatology · 2025Article
- Recurrence and influencing factors of moderate-to-severe atopic dermatitis after dupilumab withdrawal: a retrospective cohort analysis.Frontiers in medicine · 2025Article
- Long-term Remission of Atopic Dermatitis after Discontinuation of Dupilumab.Acta dermato-venereologica · 2022Article
- Base and Covariate Population Pharmacokinetic Analyses of Dupilumab in Adolescents and Children ≥6 to <12 Years of Age Using Phase 3 Data.Clinical pharmacology in drug development · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Population pharmacokinetic base and covariate models were developed to study functional dupilumab for regulatory submissions, using data from healthy volunteers and patients with moderate-to-severe atopic dermatitis (AD) receiving intravenous or subcutaneous doses. Sixteen studies were pooled (N = 2115; 202 healthy volunteers, 1913 AD patients). The best model was a 2-compartment model with linear and Michaelis-Menten elimination and 3 transit compartments describing absorption. A stepwise approach to model building, with some parameters estimated using mostly rich data and subsequently fixed, was used to avoid adverse effects of sparse data and a steep target-mediated phase on pharmacokinetic parameters, which require rich sampling for proper estimation. Parameterization of models in terms of rates was a useful alternative to the parameterization in terms of clearances, allowing for a reduced number of covariates while providing accurate predictions. While antidrug antibodies, albumin, race, body mass index, and Eczema Area and Severity Index score were statistically significant covariates, only body weight had a notable effect on central volume, explaining interindividual variability. The model adequately described dupilumab pharmacokinetics in phase 3 trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.