Clinical performance of an infliximab rapid quantification assay
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/10400.1/11905 |
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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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 instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799133267929071616 |