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Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity

AIMS: Adalimumab‐adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab‐adbm and Humira in patients with active r...

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Autores principales: Kang, Jia, Eudy‐Byrne, Rena J., Mondick, John, Knebel, William, Jayadeva, Girish, Liesenfeld, Karl‐Heinz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7576631/
https://www.ncbi.nlm.nih.gov/pubmed/32363771
http://dx.doi.org/10.1111/bcp.14330
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author Kang, Jia
Eudy‐Byrne, Rena J.
Mondick, John
Knebel, William
Jayadeva, Girish
Liesenfeld, Karl‐Heinz
author_facet Kang, Jia
Eudy‐Byrne, Rena J.
Mondick, John
Knebel, William
Jayadeva, Girish
Liesenfeld, Karl‐Heinz
author_sort Kang, Jia
collection PubMed
description AIMS: Adalimumab‐adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab‐adbm and Humira in patients with active rheumatoid arthritis (RA), to quantify the effects of potential covariates on adalimumab PK and to assess the impact of switching treatment from Humira to adalimumab‐adbm on PK. METHODS: A PPK model was firstly developed using intensive PK data from the phase‐1 study in healthy subjects (NCT02045979). PPK models were developed separately for phase‐3 base study (NCT02137226) and its extension study (NCT02640612) in patients with active RA. RESULTS: PPK models were developed for adalimumab from adalimumab‐adbm and Humira treatment in healthy subjects and RA patients. Weight and anti‐drug antibodies were found to be important predictors of adalimumab clearance. Adalimumab PK was similar between adalimumab‐adbm and Humira. The estimated effect of Humira on clearance, relative to the adalimumab‐adbm, was 1.02 (i.e., Humira has 0.02 greater clearance). Similarly, the effect of treatment arms (switching) on clearance was estimated to be 1.00 and 0.997 for Humira:Humira:BI and Humira:BI:BI arms, respectively, relative to the BI:BI:BI arm (BI refers to adalimumab‐adbm) in the phase‐3 extension study. CONCLUSION: PK similarity between adalimumab‐adbm and Humira in patients with active RA was demonstrated using PPK approach. Adalimumab PK was also similar when switching treatment from Humira to adalimumab‐adbm at either week 24 or 48.
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spelling pubmed-75766312020-10-23 Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity Kang, Jia Eudy‐Byrne, Rena J. Mondick, John Knebel, William Jayadeva, Girish Liesenfeld, Karl‐Heinz Br J Clin Pharmacol Original Articles AIMS: Adalimumab‐adbm is a monoclonal antibody developed as a biosimilar to adalimumab (Humira, AbbVie Inc.). The key objectives of this study were using a population pharmacokinetic (PPK) approach to assess pharmacokinetic (PK) similarity between adalimumab‐adbm and Humira in patients with active rheumatoid arthritis (RA), to quantify the effects of potential covariates on adalimumab PK and to assess the impact of switching treatment from Humira to adalimumab‐adbm on PK. METHODS: A PPK model was firstly developed using intensive PK data from the phase‐1 study in healthy subjects (NCT02045979). PPK models were developed separately for phase‐3 base study (NCT02137226) and its extension study (NCT02640612) in patients with active RA. RESULTS: PPK models were developed for adalimumab from adalimumab‐adbm and Humira treatment in healthy subjects and RA patients. Weight and anti‐drug antibodies were found to be important predictors of adalimumab clearance. Adalimumab PK was similar between adalimumab‐adbm and Humira. The estimated effect of Humira on clearance, relative to the adalimumab‐adbm, was 1.02 (i.e., Humira has 0.02 greater clearance). Similarly, the effect of treatment arms (switching) on clearance was estimated to be 1.00 and 0.997 for Humira:Humira:BI and Humira:BI:BI arms, respectively, relative to the BI:BI:BI arm (BI refers to adalimumab‐adbm) in the phase‐3 extension study. CONCLUSION: PK similarity between adalimumab‐adbm and Humira in patients with active RA was demonstrated using PPK approach. Adalimumab PK was also similar when switching treatment from Humira to adalimumab‐adbm at either week 24 or 48. John Wiley and Sons Inc. 2020-06-11 2020-11 /pmc/articles/PMC7576631/ /pubmed/32363771 http://dx.doi.org/10.1111/bcp.14330 Text en © 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Kang, Jia
Eudy‐Byrne, Rena J.
Mondick, John
Knebel, William
Jayadeva, Girish
Liesenfeld, Karl‐Heinz
Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title_full Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title_fullStr Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title_full_unstemmed Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title_short Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
title_sort population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7576631/
https://www.ncbi.nlm.nih.gov/pubmed/32363771
http://dx.doi.org/10.1111/bcp.14330
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