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...
| Autores: | ; ; ; ; ; |
|---|---|
| Tipo de documento: | Artículo |
| Estado: | Published version |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| Repositorio: | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| OAI Identifier: | oai:isabial.fundanetsuite.com:p7388 |
| Acceso en línea: | https://isabial.portalinvestigacion.com/publicaciones7388 |
| Nivel de acceso: | Acceso abierto |
| Palabra clave: | pharmacokinetics drug monitoring adalimumab inflammatory bowel diseases Crohn's disease colitis ulcerative |
| _version_ | 1878732877402734593 |
|---|---|
| author | Marquez-Megias, S |
| author2 | Ramon-Lopez, A Mas-Serrano, P Diaz-Gonzalez, M Candela-Boix, MR Nalda-Molina, R |
| author2_role | author author author author author |
| author_browse | Candela-Boix, MR Diaz-Gonzalez, M Marquez-Megias, S Mas-Serrano, P Nalda-Molina, R Ramon-Lopez, A |
| author_facet | Marquez-Megias, S Ramon-Lopez, A Mas-Serrano, P Diaz-Gonzalez, M Candela-Boix, MR Nalda-Molina, R |
| author_role | author |
| collection | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| 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 NPDE plots whereas predictive 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 population-pharmacokinetic 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_4b9990993aee3ee93f1e1e414db47b0b |
| institution | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| instname_str | Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL) |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:isabial.fundanetsuite.com:p7388 |
| publishDate | 2021 |
| publishDateSort | 2021 |
| publisher | MDPI |
| publisherStr | MDPI |
| reponame_str | r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante |
| spelling | Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease Marquez-Megias, S Ramon-Lopez, A Mas-Serrano, P Diaz-Gonzalez, M Candela-Boix, MR Nalda-Molina, R pharmacokinetics drug monitoring adalimumab inflammatory bowel diseases Crohn's disease colitis ulcerative 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 NPDE plots whereas predictive 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 population-pharmacokinetic 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. MDPI https://isabial.portalinvestigacion.com/publicaciones7388 |
| spellingShingle | Evaluation of the Predictive Performance of Population Pharmacokinetic Models of Adalimumab in Patients with Inflammatory Bowel Disease Marquez-Megias, S pharmacokinetics drug monitoring adalimumab inflammatory bowel diseases Crohn's disease colitis ulcerative |
| status_str | publishedVersion |
| title | 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_short | 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 |
| topic | pharmacokinetics drug monitoring adalimumab inflammatory bowel diseases Crohn's disease colitis ulcerative |
| topic_facet | pharmacokinetics drug monitoring adalimumab inflammatory bowel diseases Crohn's disease colitis ulcerative |
| url | https://isabial.portalinvestigacion.com/publicaciones7388 |