Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Gill, Katherine L.; Machavaram, Krishna K.; Rose, Rachel H.; Chetty, Manoranjenni

doi:10.1007/s40262-015-0361-4

Cited by 82Monoclonal and Polyclonal Antibodies ResearchBiosimilars and Bioanalytical MethodsPharmaceutical studies and practices

Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

Gill, Katherine L., Machavaram, Krishna K., Rose, Rachel H., Chetty, Manoranjenni·2016·Clinical Pharmacokinetics

DOI 10.1007/s40262-015-0361-4

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Abstract

Understanding inter-subject variability in drug pharmacokinetics and pharmacodynamics is important to ensure that all patients attain suitable drug exposure to achieve efficacy and avoid toxicity. Inter-subject variability in the pharmacokinetics of therapeutic monoclonal antibodies (mAbs) is generally moderate to high; however, the factors responsible for the high inter-subject variability have not been comprehensively reviewed. In this review, the extent of inter-subject variability for mAb pharmacokinetics is presented and potential factors contributing to this variability are explored and summarised. Disease status, age, sex, ethnicity, body size, genetic polymorphisms, concomitant medication, co-morbidities, immune status and multiple other patient-specific details have been considered. The inter-subject variability for mAb pharmacokinetics most likely depends on the complex interplay of multiple factors. However, studies aimed at investigating the reasons for the inter-subject variability are sparse. Population pharmacokinetic models and physiologically based pharmacokinetic models are useful tools to identify important covariates, aiding in the understanding of factors contributing to inter-subject variability. Further understanding of inter-subject variability in pharmacokinetics should aid in development of dosing regimens that are more appropriate.

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Many factors, such as antibody properties (hydrophobicity, charge, glycosylation patterns), intersubject variability (disease status, body size, genetic polymorphisms, concomitant medication, comorbidities), and immune-mediated response generated by mAbs administration, can also impact mAb clearance.
“Many other factors, such as antibody properties (hydrophobicity, charge,38 glycosylation patterns39), intersubject variability (disease status, body size, genetic polymorphisms, concomitant medication, comorbidities, etc.40), and immune‐mediated response generated by mAbs administration can also impact mAb clearance.”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [40]
Once in clinical development, clinical pharmacology studies can identify covariates and potential sources of intersubject variability, establish exposure-response relationships in patients, and aid in development of a dosing regimen.
“Once in clinical development, clinical pharmacology studies can identify the covariates and potential sources of intersubject variability; establish exposure–response relationships in patients, and aid in development of a dosing regimen.40”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [40]

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The Role of Fcγ Receptor Polymorphisms in the Response to Anti–Tumor Necrosis Factor Therapy in Psoriasis
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Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Belatacept in Adult Kidney Transplant Recipients
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Asialoglycoprotein receptor in human isolated hepatocytes from normal liver and its apparent increase in liver with histological alterations
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AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development
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Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically Based Pharmacokinetic FcRn Model
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The Utility of Modeling and Simulation Approaches to Evaluate Immunogenicity Effect on the Therapeutic Protein Pharmacokinetics
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Pharmacokinetics and immunodynamics of chimeric IL-2 receptor monoclonal antibody SDZ CHI 621 in renal allograft recipients
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Pharmacokinetic mAb–mAb Interaction: Anti-VEGF mAb Decreases the Distribution of Anti-CEA mAb into Colorectal Tumor Xenografts
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Population pharmacokinetic data analysis of three phase I studies of matuzumab, a humanised anti-EGFR monoclonal antibody in clinical cancer development
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Contribution of Renal and Non‐Renal Clearance on Increased Total Clearance of Adalimumab in Glomerular Disease
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Bioequivalence of a Novel Omalizumab Solution for Injection Compared with the Standard Lyophilized Powder Formulation
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Genetic Polymorphisme of FCGRT Encoding FcRn in a Japanese Population and Their Functional Analysis
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Development of a PBPK Model for Monoclonal Antibodies and Simulation of Human and Mice PBPK of a Radiolabelled Monoclonal Antibody
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Pharmacokinetic study and Fcγ receptor gene analysis in two patients with rheumatoid arthritis controlled by low-dose infliximab
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Hypercatabolism of IgG in mice with lupus-like syndrome
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Gray Scale and Power Doppler Sonography of Normal Cervical Lymph Nodes
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Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis.
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Predictive Physiologically Based Pharmacokinetic Model for Antibody-Directed Enzyme Prodrug Therapy
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Pharmacokinetic study and Fcγ receptor gene analysis in two patients with rheumatoid arthritis controlled by low-dose infliximab
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A phase I study of escalated dose subcutaneous alemtuzumab given weekly with rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma
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Selection of a phase 3 dose regimen for denosumab based on pharmacokinetic (PK), pharmacodynamic (PD), and safety data from multiple subcutaneous (SC) dosing regimens in breast cancer patients (pts) with bone metastases (BM).
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Polymorphisms of Neonatal Fc Receptor in Cynomolgus and Rhesus Macaques
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Pharmacokinetics and pharmacodynamics of a chimeric interleukin-2 receptor monoclonal antibody, basiliximab, in renal transplantation: a comparison between Japanese and non-Japanese patients
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Comprehensive mechanism-based antibody pharmacokinetic modeling
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Tocilizumab in patients with severe COVID-19: a retrospective cohort study
Guaraldi, G., Meschiari, M., Cozzi-Lepri, A., Milic, J., Tonelli, R., Menozzi, M., Franceschini, E., Cuomo, G., Orlando, G., Borghi, V., et al. (2020) · The Lancet Rheumatology · doi:10.1016/s2665-9913(20)30173-9 · Cited by 939 · see citing works
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Ovacik, M., & Lin, K. (2018) · Clinical and Translational Science · doi:10.1111/cts.12567 · Cited by 299 · see citing works
Immunogenicity of TNF-Inhibitors
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Paper‐Based Antibody Detection Devices Using Bioluminescent BRET‐Switching Sensor Proteins
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Peripheral and central nervous system distribution of the CGRP neutralizing antibody [ 125 I] galcanezumab in male rats
Johnson, K. W., Morin, S. M., Wroblewski, V. J., & Johnson, M. P. (2019) · Cephalalgia · doi:10.1177/0333102419844711 · Cited by 107 · see citing works
Immunogenicity of biologic agents in rheumatology
Strand, V., Gonçalves, J., & Isaacs, J. D. (2020) · Nature Reviews Rheumatology · doi:10.1038/s41584-020-00540-8 · Cited by 103 · see citing works
Understanding Inter-Individual Variability in Monoclonal Antibody Disposition
Thomas, V. A., & Balthasar, J. P. (2019) · Antibodies · doi:10.3390/antib8040056 · Cited by 101 · see citing works
Age and sex in drug development and testing for adults
Tannenbaum, C., & Day, D. (2017) · Pharmacological Research · doi:10.1016/j.phrs.2017.04.027 · Cited by 85 · see citing works
Evaluation of covariate effects on pharmacokinetics of monoclonal antibodies in oncology
Bajaj, G., Suryawanshi, S., Roy, A., & Gupta, M. (2019) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13996 · Cited by 68 · see citing works
Understanding the Monoclonal Antibody Disposition after Subcutaneous Administration using a Minimal Physiologically based Pharmacokinetic Model
Varkhede, N. R., & Forrest, L. M. (2018) · Journal of Pharmacy & Pharmaceutical Sciences · doi:10.18433/jpps30028 · Cited by 67 · see citing works
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Dual-Color Bioluminescent Sensor Proteins for Therapeutic Drug Monitoring of Antitumor Antibodies
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Pharmacokinetics and Associated Efficacy of Emicizumab in Humans: A Systematic Review
Donners, A. A. M. T., Rademaker, C. M. A., Bevers, L. A. H., Huitema, A. D. R., Schutgens, R. E. G., Egberts, T. C. G., & Fischer, K. (2021) · Clinical Pharmacokinetics · doi:10.1007/s40262-021-01042-w · Cited by 48 · see citing works
Influence of Antigen Mass on the Pharmacokinetics of Therapeutic Antibodies in Humans
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Anti-fouling poly adenine coating combined with highly specific CD20 epitope mimetic peptide for rituximab detection in clinical patients’ plasma
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Optimal Physicochemical Properties of Antibody–Nanoparticle Conjugates for Improved Tumor Targeting
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Population pharmacokinetic‐pharmacodynamic analyses of amyloid positron emission tomography and plasma biomarkers for lecanemab in subjects with early Alzheimer's disease
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Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine
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Risk factors for anti‐drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial
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Modeling Pharmacokinetics and Pharmacodynamics of Therapeutic Antibodies: Progress, Challenges, and Future Directions
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Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis
Ruperto, N., Brunner, H. I., Pacheco‐Tena, C., Louw, I., Vega‐Cornejo, G., Spindler, A. J., Kingsbury, D. J., Schmeling, H., Borzutzky, A., Cuttica, R. J., et al. (2021) · Rheumatology · doi:10.1093/rheumatology/keab021 · Cited by 34 · see citing works
Population PBPK modelling of trastuzumab: a framework for quantifying and predicting inter-individual variability
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Sex-Related Differences in Immunotherapy Toxicities: Insights into Dimorphic Responses
Canzian, J., Conforti, F., Jacobs, F., Benvenuti, C., Gaudio, M., Gerosa, R., Sanctis, R. D., & Zambelli, A. (2025) · Cancers · doi:10.3390/cancers17071054 · Cited by 31 · see citing works
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Scientific Rationale for Waiving Clinical Efficacy Testing of Biosimilars
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Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies
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Priming the body to receive the therapeutic agent to redefine treatment benefit/risk profile
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A Phase 1 Study of Ensitrelvir Fumaric Acid Tablets Evaluating the Safety, Pharmacokinetics and Food Effect in Healthy Adult Populations
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Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy
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A minimal physiologically based pharmacokinetic model to investigate FcRn-mediated monoclonal antibody salvage: Effects of Kon, Koff, endosome trafficking, and animal species
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Is there potential for therapeutic drug monitoring of biologic agents in rheumatoid arthritis?
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Population pharmacokinetic models of anti-PD-1 mAbs in patients with multiple tumor types: A systematic review
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Population pharmacokinetics and exposure–response analyses of safety ( ARIA ‐E and isolated ARIA ‐H) of lecanemab in subjects with early Alzheimer's disease
Majid, O., Cao, Y., Willis, B. A., Hayato, S., Takenaka, O., Lalovic, B. B., Reddy, S. H. S., Penner, N., Reyderman, L., Yasuda, S., et al. (2024) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.13224 · Cited by 21 · see citing works
Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations
Leu, J. H., Shiff, N. J., Clark, M., Bensley, K., Lomax, K. G., Berezny, K., Nelson, R. M., Zhou, H., & Xu, Z. (2022) · Pediatric Drugs · doi:10.1007/s40272-022-00533-y · Cited by 21 · see citing works
Pharmacokinetics and Pharmacodynamics of Intravenous Immunoglobulin G Maintenance Therapy in Chronic Immune‐mediated Neuropathies
Fokkink, W. R., Koch, B., Ramakers, C. R. B., van Doorn, P. A., van Gelder, T., & Jacobs, B. C. (2017) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.693 · Cited by 21 · see citing works
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Authors: Gill, K. L., Machavaram, K. K., Rose, R. H., & Chetty, M.
Affiliations: Simcyp (United Kingdom) (GB)
Corresponding author: Chetty, Manoranjenni
ORCID: Gill, Katherine L.
Chetty, Manoranjenni
Venue: Clinical Pharmacokinetics
Publisher: Springer Science and Business Media LLC
Published: 2016-01-27
Volume: 55
Issue: 7
Pages: 789-805
ISSN: 0312-5963 (ISSN-L)
1179-1926
DOI: 10.1007/s40262-015-0361-4
OpenAlex: W2296252503
Cited by: 82
References: 210
Citations by year: 2026: 3 · 2025: 12 · 2024: 9 · 2023: 11 · 2022: 11 · 2021: 7 · 2020: 5 · 2019: 6 · 2018: 10 · 2017: 7 · 2016: 1
FWCI: 1.24
Type: journal article
Language: en
Open access: closed
Licence: www.springer.com/tdm (tdm)
Locations: Clinical Pharmacokinetics (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: monoclonal antibodies, interindividual variability, pharmacokinetics, covariates, genetic polymorphism, population pharmacokinetic model, physiologically based pharmacokinetic modeling, dosing regimen, disease status, immune status, concomitant medications, comorbidities
MeSH terms: Age Factors, Antibodies, Monoclonal, Body Weights and Measures, Dose-Response Relationship, Drug, Drug Interactions, Ethnicity, Humans, Lymphatic System, Models, Biological, Polymorphism, Genetic, Receptors, Fc, Severity of Illness Index, Sex Factors, Histocompatibility Antigens Class I, Comorbidity

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Potential Sources of Inter-Subject Variability in Monoclonal Antibody Pharmacokinetics

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