Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays

Detalhes bibliográficos
Autor(a) principal: Afonso, Joana
Data de Publicação: 2017
Outros Autores: de Sousa, Helena Tavares, Rosa, Isadora, Carvalho, João, Dias, Claudia Camila, Magro, Fernando
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.1/11906
Resumo: Background: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. Methods: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy. Results: The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples demonstrated that these three assays were also highly correlated, both concerning Spearman's rank coefficients (range 0.890-0.947) and intraclass correlation coefficients (range 0.907-0.935). There were a few systematic deviations among them, but their impact in the clinical stratification of the patients using different cut-offs was minimal, particularly when these cut-offs were in the 3-4 mu g/ml range, for which the strength of agreement (as assessed by the Kappa statistics that ranged from 0.732 to 0.902) was substantial to almost perfect. Conclusions: Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments.
id RCAP_60e14cbde63c563393eba6dd4a5032c3
oai_identifier_str oai:sapientia.ualg.pt:10400.1/11906
network_acronym_str RCAP
network_name_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository_id_str 7160
spelling Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassaysInflammatory bowel diseaseAnti infliximab antibodiesCrohns diseaseAnkylosing spondylitisInnovator infliximabUlcerative colitisSerum infliximabParallel groupDouble blindElisa kitsBackground: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. Methods: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy. Results: The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples demonstrated that these three assays were also highly correlated, both concerning Spearman's rank coefficients (range 0.890-0.947) and intraclass correlation coefficients (range 0.907-0.935). There were a few systematic deviations among them, but their impact in the clinical stratification of the patients using different cut-offs was minimal, particularly when these cut-offs were in the 3-4 mu g/ml range, for which the strength of agreement (as assessed by the Kappa statistics that ranged from 0.732 to 0.902) was substantial to almost perfect. Conclusions: Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments.Portuguese IBD Group (GEDII, Grupo de Estudo da Doenca Inflamatoria Intestinal)Portuguese IBD Group (GEDII, Grupo de Estudo da Doença Inflamatória Intestinal)Sage Publications LtdSapientiaAfonso, Joanade Sousa, Helena TavaresRosa, IsadoraCarvalho, JoãoDias, Claudia CamilaMagro, Fernando2018-12-07T14:58:12Z2017-092017-09-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.1/11906eng1756-283X10.1177/1756283X17722915info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-07-24T10:23:48Zoai:sapientia.ualg.pt:10400.1/11906Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T20:03:20.696906Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
title Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
spellingShingle Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
Afonso, Joana
Inflammatory bowel disease
Anti infliximab antibodies
Crohns disease
Ankylosing spondylitis
Innovator infliximab
Ulcerative colitis
Serum infliximab
Parallel group
Double blind
Elisa kits
title_short Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
title_full Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
title_fullStr Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
title_full_unstemmed Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
title_sort Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
author Afonso, Joana
author_facet Afonso, Joana
de Sousa, Helena Tavares
Rosa, Isadora
Carvalho, João
Dias, Claudia Camila
Magro, Fernando
author_role author
author2 de Sousa, Helena Tavares
Rosa, Isadora
Carvalho, João
Dias, Claudia Camila
Magro, Fernando
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Sapientia
dc.contributor.author.fl_str_mv Afonso, Joana
de Sousa, Helena Tavares
Rosa, Isadora
Carvalho, João
Dias, Claudia Camila
Magro, Fernando
dc.subject.por.fl_str_mv Inflammatory bowel disease
Anti infliximab antibodies
Crohns disease
Ankylosing spondylitis
Innovator infliximab
Ulcerative colitis
Serum infliximab
Parallel group
Double blind
Elisa kits
topic Inflammatory bowel disease
Anti infliximab antibodies
Crohns disease
Ankylosing spondylitis
Innovator infliximab
Ulcerative colitis
Serum infliximab
Parallel group
Double blind
Elisa kits
description Background: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. Methods: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy. Results: The quantification of the spiked samples unveiled a consistent and accurate behaviour of three of the tested methods, with average percentage recoveries of 90%, 102% and 109%. Results from the clinical samples demonstrated that these three assays were also highly correlated, both concerning Spearman's rank coefficients (range 0.890-0.947) and intraclass correlation coefficients (range 0.907-0.935). There were a few systematic deviations among them, but their impact in the clinical stratification of the patients using different cut-offs was minimal, particularly when these cut-offs were in the 3-4 mu g/ml range, for which the strength of agreement (as assessed by the Kappa statistics that ranged from 0.732 to 0.902) was substantial to almost perfect. Conclusions: Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments.
publishDate 2017
dc.date.none.fl_str_mv 2017-09
2017-09-01T00:00:00Z
2018-12-07T14:58:12Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10400.1/11906
url http://hdl.handle.net/10400.1/11906
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1756-283X
10.1177/1756283X17722915
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Sage Publications Ltd
publisher.none.fl_str_mv Sage Publications Ltd
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
repository.mail.fl_str_mv
_version_ 1799133267932217344