ReviewThe AAPS journal2014
A white paper--consensus and recommendations of a global harmonization team on assessing the impact of immunogenicity on pharmacokinetic measurements.
Review in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
31 citing papers in PubMed, 1 synthesis or guideline pooled it.
- An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab.The AAPS journal · 2017Pooled it
- Epitope mapping of humoral immunogenicity of orvacabtagene autoleucel shows an IgM response with minimal impact on CAR T cellular kinetics.Molecular therapy. Advances · 2026Article
- Development of an electrochemiluminescence-based bridging assay to detect antibodies against a PTH inverse agonist in human plasma.Bioanalysis · 2026Article
- Axatilimab Immunogenicity and Clinical Relevance in Patients with Chronic Graft-Versus-Host Disease.Clinical pharmacology and therapeutics · 2026Article
- Mechanism-Based Modeling Approaches to Quantify the Effect of Immunogenicity on the Pharmacokinetics of Therapeutic Proteins in Drug Development.CPT: pharmacometrics & systems pharmacology · 2025Review
- IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment.Clinical pharmacology and therapeutics · 2025Review
- IQ Survey Results on Current Industry Practices: Part 2-Quantitative Evaluations of Immunogenicity Assessment.Clinical pharmacology and therapeutics · 2025Review
- High level of anti-drug antibodies is associated with shorter survival in advanced solid cancer patients treated with Immune checkpoint inhibitors.Immunotherapy advances · 2025Article
- Implications of Immunogenicity Testing for Therapeutic Monoclonal Antibodies: A Quantitative Pharmacology Framework.The AAPS journal · 2024Article
- Development and Validation of an ADA-Tolerant Assay for Quantification of an Exatecan-Based ADC in Monkey Plasma.Molecules (Basel, Switzerland) · 2024Article
- A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development.Journal of pharmacokinetics and pharmacodynamics · 2023Review
- Tumor-associated neutrophils and macrophages exacerbate antidrug IgG-mediated anaphylactic reaction against an immune checkpoint inhibitor.Journal for immunotherapy of cancer · 2022Article
- Anti-drug antibodies in the current management of cancer.Cancer chemotherapy and pharmacology · 2022Review
- Validation of an IFN-gamma ELISpot assay to measure cellular immune responses against viral antigens in non-human primates.Gene therapy · 2022Article
- Liquid chromatography-mass spectrometry method for the quantification of an anti-sclerostin monoclonal antibody in cynomolgus monkey serum.Journal of pharmaceutical analysis · 2021Article
- Development and Utility of an ELISA Method for Sensitive and Specific Detection of IgE Antidrug Antibodies.The AAPS journal · 2020Article
- Immunogenicity of pembrolizumab in patients with advanced tumors.Journal for immunotherapy of cancer · 2019Article
- Immunogenicity of Protein Pharmaceuticals.Journal of pharmaceutical sciences · 2019Review
- Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics.Journal for immunotherapy of cancer · 2019Review
- Biotherapeutics: Challenges and Opportunities for Predictive Toxicology of Monoclonal Antibodies.International journal of molecular sciences · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Global Bioanalysis Consortium (GBC) set up an international team to explore the impact of immunogenicity on pharmacokinetic (PK) assessments. The intent of this paper is to define the field and propose best practices when developing PK assays for biotherapeutics. We focus on the impact of anti-drug antibodies (ADA) on the performance of PK assay leading to the impact on the reported drug concentration and exposure. The manuscript describes strategies to assess whether the observed change in the drug concentration is due to the ADA impact on drug clearance rates or is a consequence of ADA interference in the bioanalytical method applied to measure drug concentration. This paper provides the bioanalytical scientist guidance for developing ADA-tolerant PK methods. It is essential that the data generated in the PK, ADA, pharmacodynamic and efficacy/toxicity evaluations are viewed together. Therefore, the extent for the investigation of the PK sensitivity to the presence of ADA should be driven by the project needs and risk based.
Indexed as
Identifiers
What OpenQuestion holds
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.