ArticleClinical pharmacology in drug development2020
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects.
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 39 papers.
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
39 citing papers in PubMed, 66 citations in OpenAlex.
- Population Pharmacokinetics of Dupilumab in Adults, Adolescents, and Children With Eosinophilic Esophagitis.Clinical pharmacology and therapeutics · 2026Trial
- Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis.Advances in therapy · 2024Trial
- Safety, pharmacokinetics, and pharmacodynamics of anti-IL-4Rα antibody SHR-1819 in healthy subjects: A randomized, controlled phase I study.Clinical and translational science · 2024Trial
- Effect of Dupilumab on Type 2 Biomarkers in Chronic Rhinosinusitis With Nasal Polyps: SINUS-52 Study Results.The Annals of otology, rhinology, and laryngology · 2023Trial
- Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis.Clinical and translational science · 2023Trial
- Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis.Clinical and translational science · 2022Trial
- Article
- Depemokimab: A twice yearly anti-IL 5 biologic for chronic rhinosinusitis with nasal polyps (CRSwNP) - A narrative review.Human vaccines & immunotherapeutics · 2026Review
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- "Super-Responders" to Dupilumab Treatment in Patients With Primary Diffuse Chronic Rhinosinusitis With Nasal Polyps.Allergy · 2026Article
- IL-4/STAT6-signaling Influences Local Inflammation and Regeneration Processes During Acute Pancreatitis and Promotes Fibrosis by a Direct Activation of Pancreatic Fibroblasts During Chronic Pancreatitis.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies.CPT: pharmacometrics & systems pharmacology · 2026Article
- Case Report: Dupilumab as a corticosteroid-sparing adjunct in severe mucocutaneous pemphigus vulgaris with prior avascular necrosis and chronic kidney disease.Frontiers in medicine · 2026Article
- Effectiveness and renal safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis patients with chronic kidney disease stages 4-5: a real-world cohort study in China.Frontiers in medicine · 2026Article
- Efficacy and safety of dupilumab in moderate-to-severe atopic dermatitis with stage 3-5 chronic kidney disease: a retrospective real-world study.Frontiers in medicine · 2026Article
- Dupilumab opens a therapeutic window in food protein-induced enterocolitis syndrome by unlicensing dendritic cells.The journal of allergy and clinical immunology. Global · 2026Article
- Current and Emerging Therapies for Eosinophilic Esophagitis (EoE): A Comprehensive Review.Pharmaceutics · 2025Review
- Exploring dupilumab for asthma: from mechanistic insights to clinical outcomes, safety, and cost-effectiveness.Frontiers in pharmacology · 2025Review
- Eosinophilic esophagitis.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2024Review
- Diagnostics of allergic rhinitis under dupilumab therapy.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dupilumab is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases, including atopic dermatitis and asthma. Six phase 1 studies investigated the pharmacokinetics, pharmacodynamics, safety, and tolerability of dupilumab in healthy subjects. Two randomized, double-blind, placebo-controlled, sequential studies assessed safety and tolerability of single escalating dupilumab doses administered intravenously or subcutaneously (one included various racial groups, and one included exclusively Japanese subjects); 3 randomized, parallel-group, single-dose studies compared the pharmacokinetic profiles of different dupilumab products and formulations after single subcutaneous doses; and one study assessed dupilumab administered as fast versus slow subcutaneous injections. Dupilumab concentrations in serum were measured in all studies, and total immunoglobulin E (IgE) and thymus- and activation-regulated chemokine (TARC) concentrations were measured in 2 studies as pharmacodynamic markers. Across the phase 1 studies, dupilumab exhibited target-mediated pharmacokinetics consisting of parallel linear and nonlinear elimination, with the target-mediated phase highly dominated by nonlinearity at lower drug concentrations. Systemic exposure and tolerability of dupilumab were consistent irrespective of differences in product, formulation, or racial background. Dupilumab reduced circulating concentrations of total IgE and TARC, indicating blockade of IL-4Rα-mediated signaling. Dupilumab had a favorable safety profile across the wide range of doses administered. Together, these findings support the continued development and use of dupilumab in treatment of type 2 diseases.
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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.