Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease

Adalimumab is a monoclonal antibody used for inflammatory bowel disease. Due to its considerably variable pharmacokinetics, the loss of response and the development of anti-antibodies, it is highly recommended to use a model-informed precision dosing approach. The aim of this study is to evaluate th...

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Autores: Marquez-Megias, Silvia, Ramon-Lopez, Amelia, Más-Serrano, Patricio, Diaz-Gonzalez, Marcos, Candela-Boix, Maria Remedios, nalda-molina, Ricardo
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universidad Miguel Hernández de Elche
Repositorio:REDIUMH. Depósito Digital de la UMH
OAI Identifier:oai:dspace.umh.es:11000/34574
Acceso en línea:https://hdl.handle.net/11000/34574
Access Level:acceso abierto
Palabra clave:pharmacokinetics
drug monitoring
adalimumab
inflammatory bowel diseases
Crohn’s disease
colitis
ulcerative
CDU::6 - Ciencias aplicadas::62 - Ingeniería. Tecnología
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spelling Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel DiseaseMarquez-Megias, SilviaRamon-Lopez, AmeliaMás-Serrano, PatricioDiaz-Gonzalez, MarcosCandela-Boix, Maria Remediosnalda-molina, Ricardopharmacokineticsdrug monitoringadalimumabinflammatory bowel diseasesCrohn’s diseasecolitisulcerativeCDU::6 - Ciencias aplicadas::62 - Ingeniería. TecnologíaAdalimumab is a monoclonal antibody used for inflammatory bowel disease. Due to its considerably variable pharmacokinetics, the loss of response and the development of anti-antibodies, it is highly recommended to use a model-informed precision dosing approach. The aim of this study is to evaluate the predictive performance of different population-pharmacokinetic models of adalimumab for inflammatory bowel disease to determine the pharmacokinetic model(s) that best suit our population to use in the clinical routine. A retrospective observational study with 134 patients was conducted at the General University Hospital of Alicante between 2014 and 2019. Model adequacy of each model was evaluated by the distribution of the individual pharmacokinetic parameters and the NPDEplotswhereaspredictive performance was assessed by calculating bias and precision. Moreover, stochastic simulations were performed to optimize the maintenance doses in the clinical protocols, to reach the target of 8 mg/L in at least 75% of the population. Two populationpharmacokinetic models were selected out of the six found in the literature which performed better in terms of adequacy and predictive performance. The stochastic simulations suggested the benefits of increasing the maintenance dose in protocol to reach the 8 mg/L targetMDPIDepartamentos de la UMH::Ingeniería202520252021info:eu-repo/semantics/articleapplication/pdf13application/pdfhttps://hdl.handle.net/11000/34574reponame:REDIUMH. Depósito Digital de la UMHinstname:Universidad Miguel Hernández de ElcheIngléshttps://doi.org/10.3390/ pharmaceutics13081244info:eu-repo/semantics/openAccessAttribution-NonCommercial-NoDerivatives 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/oai:dspace.umh.es:11000/345742026-05-27T13:36:21Z
dc.title.none.fl_str_mv Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
title Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
spellingShingle Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
Marquez-Megias, Silvia
pharmacokinetics
drug monitoring
adalimumab
inflammatory bowel diseases
Crohn’s disease
colitis
ulcerative
CDU::6 - Ciencias aplicadas::62 - Ingeniería. Tecnología
title_short Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
title_full Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
title_fullStr Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
title_full_unstemmed Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
title_sort Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease
dc.creator.none.fl_str_mv Marquez-Megias, Silvia
Ramon-Lopez, Amelia
Más-Serrano, Patricio
Diaz-Gonzalez, Marcos
Candela-Boix, Maria Remedios
nalda-molina, Ricardo
author Marquez-Megias, Silvia
author_facet Marquez-Megias, Silvia
Ramon-Lopez, Amelia
Más-Serrano, Patricio
Diaz-Gonzalez, Marcos
Candela-Boix, Maria Remedios
nalda-molina, Ricardo
author_role author
author2 Ramon-Lopez, Amelia
Más-Serrano, Patricio
Diaz-Gonzalez, Marcos
Candela-Boix, Maria Remedios
nalda-molina, Ricardo
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Departamentos de la UMH::Ingeniería
dc.subject.none.fl_str_mv pharmacokinetics
drug monitoring
adalimumab
inflammatory bowel diseases
Crohn’s disease
colitis
ulcerative
CDU::6 - Ciencias aplicadas::62 - Ingeniería. Tecnología
topic pharmacokinetics
drug monitoring
adalimumab
inflammatory bowel diseases
Crohn’s disease
colitis
ulcerative
CDU::6 - Ciencias aplicadas::62 - Ingeniería. Tecnología
description Adalimumab is a monoclonal antibody used for inflammatory bowel disease. Due to its considerably variable pharmacokinetics, the loss of response and the development of anti-antibodies, it is highly recommended to use a model-informed precision dosing approach. The aim of this study is to evaluate the predictive performance of different population-pharmacokinetic models of adalimumab for inflammatory bowel disease to determine the pharmacokinetic model(s) that best suit our population to use in the clinical routine. A retrospective observational study with 134 patients was conducted at the General University Hospital of Alicante between 2014 and 2019. Model adequacy of each model was evaluated by the distribution of the individual pharmacokinetic parameters and the NPDEplotswhereaspredictive performance was assessed by calculating bias and precision. Moreover, stochastic simulations were performed to optimize the maintenance doses in the clinical protocols, to reach the target of 8 mg/L in at least 75% of the population. Two populationpharmacokinetic models were selected out of the six found in the literature which performed better in terms of adequacy and predictive performance. The stochastic simulations suggested the benefits of increasing the maintenance dose in protocol to reach the 8 mg/L target
publishDate 2021
dc.date.none.fl_str_mv 2021
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/11000/34574
url https://hdl.handle.net/11000/34574
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://doi.org/10.3390/ pharmaceutics13081244
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
Attribution-NonCommercial-NoDerivatives 4.0 Internacional
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 Internacional
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.format.none.fl_str_mv application/pdf
13
application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:REDIUMH. Depósito Digital de la UMH
instname:Universidad Miguel Hernández de Elche
instname_str Universidad Miguel Hernández de Elche
reponame_str REDIUMH. Depósito Digital de la UMH
collection REDIUMH. Depósito Digital de la UMH
repository.name.fl_str_mv
repository.mail.fl_str_mv
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