Clinical performance of an infliximab rapid quantification assay

Detalhes bibliográficos
Autor(a) principal: Magro, Fernando
Data de Publicação: 2017
Outros Autores: Afonso, Joana, Lopes, Susana, Coelho, Rosa, Gonçalves, Raquel, Caldeira, Paulo, Lago, Paula, Sousa, Helena Tavares, Ramos, Jaime, Gonçalves, Ana Rita, Ministro, Paula, Rosa, Isadora, Meira, Tania, Andrade, Patrícia, Soares, João-Bruno, Carvalho, Diana, Sousa, Paula, Vieira, Ana Isabel, Lopes, Joanne, Dias, Cláudia Camila, Geboes, Karel, Carneiro, Fátima
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10400.1/11905
Resumo: Background: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 mu g/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 mu g/ml was 88% both for a Mayo endoscopic score <= 1 and for an FC concentration <250 mu g/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 mu g/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.
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spelling Clinical performance of an infliximab rapid quantification assayInflammatory-bowel-diseaseUlcerative-colitisCrohns-diseaseSerum infliximabElisa KitsAntibodiesTherapyOptimizationAssociationCohortBackground: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 mu g/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 mu g/ml was 88% both for a Mayo endoscopic score <= 1 and for an FC concentration <250 mu g/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 mu g/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.Portuguese IBD Group (GEDII, Grupo de Estudo da Doenca Inflamatoria Intestinal)Sage Publications LtdSapientiaMagro, FernandoAfonso, JoanaLopes, SusanaCoelho, RosaGonçalves, RaquelCaldeira, PauloLago, PaulaSousa, Helena TavaresRamos, JaimeGonçalves, Ana RitaMinistro, PaulaRosa, IsadoraMeira, TaniaAndrade, PatríciaSoares, João-BrunoCarvalho, DianaSousa, PaulaVieira, Ana IsabelLopes, JoanneDias, Cláudia CamilaGeboes, KarelCarneiro, Fátima2018-12-07T14:58:11Z2017-092017-09-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.1/11905eng1756-283X10.1177/1756283X17722916info: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:10400.1/11905Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T20:03:20.642524Repositório 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 Clinical performance of an infliximab rapid quantification assay
title Clinical performance of an infliximab rapid quantification assay
spellingShingle Clinical performance of an infliximab rapid quantification assay
Magro, Fernando
Inflammatory-bowel-disease
Ulcerative-colitis
Crohns-disease
Serum infliximab
Elisa Kits
Antibodies
Therapy
Optimization
Association
Cohort
title_short Clinical performance of an infliximab rapid quantification assay
title_full Clinical performance of an infliximab rapid quantification assay
title_fullStr Clinical performance of an infliximab rapid quantification assay
title_full_unstemmed Clinical performance of an infliximab rapid quantification assay
title_sort Clinical performance of an infliximab rapid quantification assay
author Magro, Fernando
author_facet Magro, Fernando
Afonso, Joana
Lopes, Susana
Coelho, Rosa
Gonçalves, Raquel
Caldeira, Paulo
Lago, Paula
Sousa, Helena Tavares
Ramos, Jaime
Gonçalves, Ana Rita
Ministro, Paula
Rosa, Isadora
Meira, Tania
Andrade, Patrícia
Soares, João-Bruno
Carvalho, Diana
Sousa, Paula
Vieira, Ana Isabel
Lopes, Joanne
Dias, Cláudia Camila
Geboes, Karel
Carneiro, Fátima
author_role author
author2 Afonso, Joana
Lopes, Susana
Coelho, Rosa
Gonçalves, Raquel
Caldeira, Paulo
Lago, Paula
Sousa, Helena Tavares
Ramos, Jaime
Gonçalves, Ana Rita
Ministro, Paula
Rosa, Isadora
Meira, Tania
Andrade, Patrícia
Soares, João-Bruno
Carvalho, Diana
Sousa, Paula
Vieira, Ana Isabel
Lopes, Joanne
Dias, Cláudia Camila
Geboes, Karel
Carneiro, Fátima
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Sapientia
dc.contributor.author.fl_str_mv Magro, Fernando
Afonso, Joana
Lopes, Susana
Coelho, Rosa
Gonçalves, Raquel
Caldeira, Paulo
Lago, Paula
Sousa, Helena Tavares
Ramos, Jaime
Gonçalves, Ana Rita
Ministro, Paula
Rosa, Isadora
Meira, Tania
Andrade, Patrícia
Soares, João-Bruno
Carvalho, Diana
Sousa, Paula
Vieira, Ana Isabel
Lopes, Joanne
Dias, Cláudia Camila
Geboes, Karel
Carneiro, Fátima
dc.subject.por.fl_str_mv Inflammatory-bowel-disease
Ulcerative-colitis
Crohns-disease
Serum infliximab
Elisa Kits
Antibodies
Therapy
Optimization
Association
Cohort
topic Inflammatory-bowel-disease
Ulcerative-colitis
Crohns-disease
Serum infliximab
Elisa Kits
Antibodies
Therapy
Optimization
Association
Cohort
description Background: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. Methods: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit. Results: Irrespective of the assay used to measure IFX, its through levels were statistically different between patients with and without endoscopic remission (Mayo endoscopic score = 0), as well as between patients stratified by their faecal calprotectin (FC) levels. Despite the fact that the two methods correlated well with each other [Spearman's rank correlation coefficient = 0.843, p < 0.001; intraclass correlation coefficients = 0.857, 95% confidence interval (CI): 0.791-0.903], there was a discernible systematic variation; values obtained with the reference kit were on average 2.62 units higher than those obtained with the rapid assay. Notwithstanding, 3 mu g/ml was shown to be an acceptable cut-off to assess endoscopic status and inflammatory burden levels using both assays. The percentage of patients that had a positive outcome when the IFX concentration measured by the rapid assay ranked above 3 mu g/ml was 88% both for a Mayo endoscopic score <= 1 and for an FC concentration <250 mu g/g. Conclusions: Based on this study, we concluded that using the rapid IFX assessment system with a 3 mu g/ml threshold is a reliable alternative to the time-consuming enzyme-linked immunosorbent assays in patients on the maintenance phase of IFX.
publishDate 2017
dc.date.none.fl_str_mv 2017-09
2017-09-01T00:00:00Z
2018-12-07T14:58:11Z
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/10400.1/11905
url http://hdl.handle.net/10400.1/11905
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1756-283X
10.1177/1756283X17722916
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
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
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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
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