Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays
Autor(a) principal: | |
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Data de Publicação: | 2017 |
Outros Autores: | , , , , |
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. |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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7160 |
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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 |
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1799133267932217344 |