Trial reportThe AAPS journal2013
Stratification of antibody-positive subjects by antibody level reveals an impact of immunogenicity on pharmacokinetics.
Trial report in The AAPS journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 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
28 citing papers in PubMed, 53 citations in OpenAlex.
- The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate.Rheumatology (Oxford, England) · 2023Trial
- Immunogenicity of LY2963016 insulin glargine and Lantus® insulin glargine in Chinese patients with type 1 or type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2022Trial
- Pharmacokinetics, Pharmacodynamics and Immunogenicity of AC02, a Novel Synthetic Derivate Peptide of Human Adrenocorticotropic Hormone for Infantile Spasms.Pharmaceutics · 2026Article
- Drawing a line in the sand: impact of analytical choices on anti-drug antibody cut-points and testing outcomes.Bioanalysis · 2026Article
- ADA assays for high-dose biologics: redefining drug tolerance through clinical insights.Bioanalysis · 2026Article
- Pre-existing anti-polyethylene glycol antibodies in pregnant women and newborns.Journal of nanobiotechnology · 2026Observational
- Refined ADA testing strategy to overcome sRANKL interference in denosumab/FKS518 immunogenicity assessment.Bioanalysis · 2025Article
- Article
- Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live Without.The AAPS journal · 2025Article
- Impacts of anti-drug antibodies on pharmacokinetic and pharmacodynamic actions of cell-permeable middle molecule peptide drug.The Journal of pharmacology and experimental therapeutics · 2025Article
- IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment.Clinical pharmacology and therapeutics · 2025Review
- Prevalence and characterization of anti-VWF antibodies in a population of patients with type 3 VWD.Blood advances · 2024Article
- Efficacy and Safety of LY2963016 Insulin Glargine in Chinese Patients with Type 1 Diabetes Previously Treated with Insulin Glargine (LantusDiabetes therapy : research, treatment and education of diabetes and related disorders · 2022Article
- Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars.Drug design, development and therapy · 2022Article
- Modeling Pharmacokinetics and Pharmacodynamics of Therapeutic Antibodies: Progress, Challenges, and Future Directions.Pharmaceutics · 2021Review
- Flow cytometry analysis of anti-polyethylene glycol antibodies in human plasma.Toxicology reports · 2021Article
- A Tiered Approach for Characterization to Ensure Quality, Reproducibility, and Long-Term Stability of Critical Reagents in Regulated Bioanalysis to Support PK/ADA/NAb Assays for Biologics and Vaccines Programs.ACS pharmacology & translational science · 2020Article
- Soluble dimeric prion protein ligand activates Adgrg6 receptor but does not rescue early signs of demyelination in PrP-deficient mice.PloS one · 2020Article
- Architectural Modification of Conformal PEG-Bottlebrush Coatings Minimizes Anti-PEG Antigenicity While Preserving Stealth Properties.Advanced healthcare materials · 2019Article
- Tutorial on Monoclonal Antibody Pharmacokinetics and Its Considerations in Early Development.Clinical and translational science · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The availability of highly sensitive immunoassays enables the detection of antidrug antibody (ADA) responses of various concentrations and affinities. The analysis of the impact of antibody status on drug pharmacokinetics (PK) is confounded by the presence of low-affinity or low-concentration antibody responses within the dataset. In a phase 2 clinical trial, a large proportion of subjects (45%) developed ADA following weekly dosing with AMG 317, a fully human monoclonal antibody therapeutic. The antibody responses displayed a wide range of relative concentrations (30 ng/mL to >13 μg/mL) and peaked at various times during the study. To evaluate the impact of immunogenicity on PK, AMG 317 concentration data were analyzed following stratification by dose group, time point, antibody status (positive or negative), and antibody level (relative concentration). With dose group as a stratifying variable, a moderate reduction in AMG 317 levels (<50%) was observed in antibody-positive subjects when compared to antibody-negative subjects, but the difference was not statistically significant in all dose groups. The most significant reduction in AMG 317 levels was revealed when antibody data was stratified by both time point and antibody level. In general, high ADA concentrations (>500 ng/mL) and later time points (week 12) were associated with significantly (up to 97%) lower trough AMG 317 concentrations. The use of quasi-quantitative antibody data and appropriate statistical methods was critical for the most comprehensive evaluation of the impact of immunogenicity on PK.
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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.