Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab
[Display omitted] The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of...
Gespeichert in:
| Veröffentlicht in: | Biochemical pharmacology 2016-12, Vol.122, p.33-41 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 41 |
|---|---|
| container_issue | |
| container_start_page | 33 |
| container_title | Biochemical pharmacology |
| container_volume | 122 |
| creator | Hernández-Breijo, B. Chaparro, M. Cano-Martínez, D. Guerra, I. Iborra, M. Cabriada, J.L. Bujanda, L. Taxonera, C. García-Sánchez, V. Marín-Jiménez, I. Barreiro-de Acosta, M. Vera, I. Martín-Arranz, M.D. Mesonero, F. Sempere, L. Gomollón, F. Hinojosa, J. Gisbert, J.P. Guijarro, L.G. |
| description | [Display omitted]
The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels.
In this prospective longitudinal multicenter study, 50 IFX-treated Crohn’s disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed. Monomeric ATI levels were measured by a quantitative HMSA-method using an anti-IFX calibrator. IFX trough levels measured by ELISA were correlated with ATI levels.
Using HMSA and a pure anti-idiotypic monoclonal antibody specific for IFX (anti-IFX calibrator), we measured the levels of monomeric ATI generated in Crohn’s disease patients treated with IFX. Anti-IFX calibrator allowed to quantify monomeric antibodies against IFX with a low limit of quantification (3nM). The threshold level of ATI in order to classify the immunogenicity of the patients was 10nM. We observed that 24% (12/50) of IFX-treated patients developed ATI (>10nM) during the observation period (54weeks). Serum concentration of ATI higher than 10nM dramatically increased the probability (OR=51.1; 95% CI: 20.4–128.0; p |
| doi_str_mv | 10.1016/j.bcp.2016.09.019 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1835397102</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0006295216303021</els_id><sourcerecordid>1835397102</sourcerecordid><originalsourceid>FETCH-LOGICAL-c353t-fdebc0da9bf0421e6de32d16dd335b898c96392505e308f68020d16dd6fc0f343</originalsourceid><addsrcrecordid>eNp9UUtuFDEQtRARGQIHYIO8ZNONP9Met1hFIxKQIrEIrC23XaY96m43tidhsuIaXCaH4SR4ZkIQG1ZVpXrv1ech9IqSmhIq3m7qzsw1K2lN2prQ9glaULniFWuFfIoWhBBR8oadoucpbfalFPQZOmUrIZayWS7Q_XXWk9XR-judfZhwcDj3gPswhq8wQdgmPIbODz7vcOq9y1inpHd4jiEHEwbsQsRwo4ftI19P2Vd-coP_7kfdHeouWA-pxufzPHjzz6gRch8szgGvY-inXz9-Jmx9Ap0AzwUJU044R9AZLL71ucd_tV-gE6eHBC8f4hn6cvH-8_pDdfXp8uP6_KoyvOG5chY6Q6xuO0eWjIKwwJmlwlrOm0620rSCt6whDXAinZCEkUNbOEMcX_Iz9OaoW87-toWU1eiTgWHQhxcpKsucdkUJK1B6hJoYUorg1BzLqnGnKFF729RGFdvU3jZFWlVsK5zXD_LbbgT7yPjjUwG8OwKgHHnjIapkymMMWB_BZGWD_4_8b7w0rwU</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1835397102</pqid></control><display><type>article</type><title>Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><creator>Hernández-Breijo, B. ; Chaparro, M. ; Cano-Martínez, D. ; Guerra, I. ; Iborra, M. ; Cabriada, J.L. ; Bujanda, L. ; Taxonera, C. ; García-Sánchez, V. ; Marín-Jiménez, I. ; Barreiro-de Acosta, M. ; Vera, I. ; Martín-Arranz, M.D. ; Mesonero, F. ; Sempere, L. ; Gomollón, F. ; Hinojosa, J. ; Gisbert, J.P. ; Guijarro, L.G.</creator><creatorcontrib>Hernández-Breijo, B. ; Chaparro, M. ; Cano-Martínez, D. ; Guerra, I. ; Iborra, M. ; Cabriada, J.L. ; Bujanda, L. ; Taxonera, C. ; García-Sánchez, V. ; Marín-Jiménez, I. ; Barreiro-de Acosta, M. ; Vera, I. ; Martín-Arranz, M.D. ; Mesonero, F. ; Sempere, L. ; Gomollón, F. ; Hinojosa, J. ; Gisbert, J.P. ; Guijarro, L.G. ; on behalf of the PREDICROHN study group from GETECCU ; PREDICROHN study group from GETECCU</creatorcontrib><description>[Display omitted]
The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels.
In this prospective longitudinal multicenter study, 50 IFX-treated Crohn’s disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed. Monomeric ATI levels were measured by a quantitative HMSA-method using an anti-IFX calibrator. IFX trough levels measured by ELISA were correlated with ATI levels.
Using HMSA and a pure anti-idiotypic monoclonal antibody specific for IFX (anti-IFX calibrator), we measured the levels of monomeric ATI generated in Crohn’s disease patients treated with IFX. Anti-IFX calibrator allowed to quantify monomeric antibodies against IFX with a low limit of quantification (3nM). The threshold level of ATI in order to classify the immunogenicity of the patients was 10nM. We observed that 24% (12/50) of IFX-treated patients developed ATI (>10nM) during the observation period (54weeks). Serum concentration of ATI higher than 10nM dramatically increased the probability (OR=51.1; 95% CI: 20.4–128.0; p<0.0001) of presenting low levels of IFX (⩽1.5nM) in serum, as observed in some CD patients treated with standard doses of the drug.
The HMSA-method described here allows an accurate quantification of ATI concentration in international units (IU) and therefore it could be useful in the study of the relationship between ATI concentration, infliximab level and the clinical response to the drug.</description><identifier>ISSN: 0006-2952</identifier><identifier>EISSN: 1873-2968</identifier><identifier>DOI: 10.1016/j.bcp.2016.09.019</identifier><identifier>PMID: 27664854</identifier><language>eng</language><publisher>England: Elsevier Inc</publisher><subject>Anti-drug antibodies ; Antibodies - blood ; Crohn Disease - blood ; Crohn Disease - drug therapy ; Crohn’s disease ; Electrophoretic Mobility Shift Assay - methods ; HMSA ; Humans ; Infliximab ; Infliximab - therapeutic use ; Prospective Studies</subject><ispartof>Biochemical pharmacology, 2016-12, Vol.122, p.33-41</ispartof><rights>2016 Elsevier Inc.</rights><rights>Copyright © 2016 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-fdebc0da9bf0421e6de32d16dd335b898c96392505e308f68020d16dd6fc0f343</citedby><cites>FETCH-LOGICAL-c353t-fdebc0da9bf0421e6de32d16dd335b898c96392505e308f68020d16dd6fc0f343</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0006295216303021$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27664854$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hernández-Breijo, B.</creatorcontrib><creatorcontrib>Chaparro, M.</creatorcontrib><creatorcontrib>Cano-Martínez, D.</creatorcontrib><creatorcontrib>Guerra, I.</creatorcontrib><creatorcontrib>Iborra, M.</creatorcontrib><creatorcontrib>Cabriada, J.L.</creatorcontrib><creatorcontrib>Bujanda, L.</creatorcontrib><creatorcontrib>Taxonera, C.</creatorcontrib><creatorcontrib>García-Sánchez, V.</creatorcontrib><creatorcontrib>Marín-Jiménez, I.</creatorcontrib><creatorcontrib>Barreiro-de Acosta, M.</creatorcontrib><creatorcontrib>Vera, I.</creatorcontrib><creatorcontrib>Martín-Arranz, M.D.</creatorcontrib><creatorcontrib>Mesonero, F.</creatorcontrib><creatorcontrib>Sempere, L.</creatorcontrib><creatorcontrib>Gomollón, F.</creatorcontrib><creatorcontrib>Hinojosa, J.</creatorcontrib><creatorcontrib>Gisbert, J.P.</creatorcontrib><creatorcontrib>Guijarro, L.G.</creatorcontrib><creatorcontrib>on behalf of the PREDICROHN study group from GETECCU</creatorcontrib><creatorcontrib>PREDICROHN study group from GETECCU</creatorcontrib><title>Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab</title><title>Biochemical pharmacology</title><addtitle>Biochem Pharmacol</addtitle><description>[Display omitted]
The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels.
In this prospective longitudinal multicenter study, 50 IFX-treated Crohn’s disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed. Monomeric ATI levels were measured by a quantitative HMSA-method using an anti-IFX calibrator. IFX trough levels measured by ELISA were correlated with ATI levels.
Using HMSA and a pure anti-idiotypic monoclonal antibody specific for IFX (anti-IFX calibrator), we measured the levels of monomeric ATI generated in Crohn’s disease patients treated with IFX. Anti-IFX calibrator allowed to quantify monomeric antibodies against IFX with a low limit of quantification (3nM). The threshold level of ATI in order to classify the immunogenicity of the patients was 10nM. We observed that 24% (12/50) of IFX-treated patients developed ATI (>10nM) during the observation period (54weeks). Serum concentration of ATI higher than 10nM dramatically increased the probability (OR=51.1; 95% CI: 20.4–128.0; p<0.0001) of presenting low levels of IFX (⩽1.5nM) in serum, as observed in some CD patients treated with standard doses of the drug.
The HMSA-method described here allows an accurate quantification of ATI concentration in international units (IU) and therefore it could be useful in the study of the relationship between ATI concentration, infliximab level and the clinical response to the drug.</description><subject>Anti-drug antibodies</subject><subject>Antibodies - blood</subject><subject>Crohn Disease - blood</subject><subject>Crohn Disease - drug therapy</subject><subject>Crohn’s disease</subject><subject>Electrophoretic Mobility Shift Assay - methods</subject><subject>HMSA</subject><subject>Humans</subject><subject>Infliximab</subject><subject>Infliximab - therapeutic use</subject><subject>Prospective Studies</subject><issn>0006-2952</issn><issn>1873-2968</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UUtuFDEQtRARGQIHYIO8ZNONP9Met1hFIxKQIrEIrC23XaY96m43tidhsuIaXCaH4SR4ZkIQG1ZVpXrv1ech9IqSmhIq3m7qzsw1K2lN2prQ9glaULniFWuFfIoWhBBR8oadoucpbfalFPQZOmUrIZayWS7Q_XXWk9XR-judfZhwcDj3gPswhq8wQdgmPIbODz7vcOq9y1inpHd4jiEHEwbsQsRwo4ftI19P2Vd-coP_7kfdHeouWA-pxufzPHjzz6gRch8szgGvY-inXz9-Jmx9Ap0AzwUJU044R9AZLL71ucd_tV-gE6eHBC8f4hn6cvH-8_pDdfXp8uP6_KoyvOG5chY6Q6xuO0eWjIKwwJmlwlrOm0620rSCt6whDXAinZCEkUNbOEMcX_Iz9OaoW87-toWU1eiTgWHQhxcpKsucdkUJK1B6hJoYUorg1BzLqnGnKFF729RGFdvU3jZFWlVsK5zXD_LbbgT7yPjjUwG8OwKgHHnjIapkymMMWB_BZGWD_4_8b7w0rwU</recordid><startdate>20161215</startdate><enddate>20161215</enddate><creator>Hernández-Breijo, B.</creator><creator>Chaparro, M.</creator><creator>Cano-Martínez, D.</creator><creator>Guerra, I.</creator><creator>Iborra, M.</creator><creator>Cabriada, J.L.</creator><creator>Bujanda, L.</creator><creator>Taxonera, C.</creator><creator>García-Sánchez, V.</creator><creator>Marín-Jiménez, I.</creator><creator>Barreiro-de Acosta, M.</creator><creator>Vera, I.</creator><creator>Martín-Arranz, M.D.</creator><creator>Mesonero, F.</creator><creator>Sempere, L.</creator><creator>Gomollón, F.</creator><creator>Hinojosa, J.</creator><creator>Gisbert, J.P.</creator><creator>Guijarro, L.G.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20161215</creationdate><title>Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab</title><author>Hernández-Breijo, B. ; Chaparro, M. ; Cano-Martínez, D. ; Guerra, I. ; Iborra, M. ; Cabriada, J.L. ; Bujanda, L. ; Taxonera, C. ; García-Sánchez, V. ; Marín-Jiménez, I. ; Barreiro-de Acosta, M. ; Vera, I. ; Martín-Arranz, M.D. ; Mesonero, F. ; Sempere, L. ; Gomollón, F. ; Hinojosa, J. ; Gisbert, J.P. ; Guijarro, L.G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-fdebc0da9bf0421e6de32d16dd335b898c96392505e308f68020d16dd6fc0f343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Anti-drug antibodies</topic><topic>Antibodies - blood</topic><topic>Crohn Disease - blood</topic><topic>Crohn Disease - drug therapy</topic><topic>Crohn’s disease</topic><topic>Electrophoretic Mobility Shift Assay - methods</topic><topic>HMSA</topic><topic>Humans</topic><topic>Infliximab</topic><topic>Infliximab - therapeutic use</topic><topic>Prospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hernández-Breijo, B.</creatorcontrib><creatorcontrib>Chaparro, M.</creatorcontrib><creatorcontrib>Cano-Martínez, D.</creatorcontrib><creatorcontrib>Guerra, I.</creatorcontrib><creatorcontrib>Iborra, M.</creatorcontrib><creatorcontrib>Cabriada, J.L.</creatorcontrib><creatorcontrib>Bujanda, L.</creatorcontrib><creatorcontrib>Taxonera, C.</creatorcontrib><creatorcontrib>García-Sánchez, V.</creatorcontrib><creatorcontrib>Marín-Jiménez, I.</creatorcontrib><creatorcontrib>Barreiro-de Acosta, M.</creatorcontrib><creatorcontrib>Vera, I.</creatorcontrib><creatorcontrib>Martín-Arranz, M.D.</creatorcontrib><creatorcontrib>Mesonero, F.</creatorcontrib><creatorcontrib>Sempere, L.</creatorcontrib><creatorcontrib>Gomollón, F.</creatorcontrib><creatorcontrib>Hinojosa, J.</creatorcontrib><creatorcontrib>Gisbert, J.P.</creatorcontrib><creatorcontrib>Guijarro, L.G.</creatorcontrib><creatorcontrib>on behalf of the PREDICROHN study group from GETECCU</creatorcontrib><creatorcontrib>PREDICROHN study group from GETECCU</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Biochemical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hernández-Breijo, B.</au><au>Chaparro, M.</au><au>Cano-Martínez, D.</au><au>Guerra, I.</au><au>Iborra, M.</au><au>Cabriada, J.L.</au><au>Bujanda, L.</au><au>Taxonera, C.</au><au>García-Sánchez, V.</au><au>Marín-Jiménez, I.</au><au>Barreiro-de Acosta, M.</au><au>Vera, I.</au><au>Martín-Arranz, M.D.</au><au>Mesonero, F.</au><au>Sempere, L.</au><au>Gomollón, F.</au><au>Hinojosa, J.</au><au>Gisbert, J.P.</au><au>Guijarro, L.G.</au><aucorp>on behalf of the PREDICROHN study group from GETECCU</aucorp><aucorp>PREDICROHN study group from GETECCU</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab</atitle><jtitle>Biochemical pharmacology</jtitle><addtitle>Biochem Pharmacol</addtitle><date>2016-12-15</date><risdate>2016</risdate><volume>122</volume><spage>33</spage><epage>41</epage><pages>33-41</pages><issn>0006-2952</issn><eissn>1873-2968</eissn><abstract>[Display omitted]
The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels.
In this prospective longitudinal multicenter study, 50 IFX-treated Crohn’s disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed. Monomeric ATI levels were measured by a quantitative HMSA-method using an anti-IFX calibrator. IFX trough levels measured by ELISA were correlated with ATI levels.
Using HMSA and a pure anti-idiotypic monoclonal antibody specific for IFX (anti-IFX calibrator), we measured the levels of monomeric ATI generated in Crohn’s disease patients treated with IFX. Anti-IFX calibrator allowed to quantify monomeric antibodies against IFX with a low limit of quantification (3nM). The threshold level of ATI in order to classify the immunogenicity of the patients was 10nM. We observed that 24% (12/50) of IFX-treated patients developed ATI (>10nM) during the observation period (54weeks). Serum concentration of ATI higher than 10nM dramatically increased the probability (OR=51.1; 95% CI: 20.4–128.0; p<0.0001) of presenting low levels of IFX (⩽1.5nM) in serum, as observed in some CD patients treated with standard doses of the drug.
The HMSA-method described here allows an accurate quantification of ATI concentration in international units (IU) and therefore it could be useful in the study of the relationship between ATI concentration, infliximab level and the clinical response to the drug.</abstract><cop>England</cop><pub>Elsevier Inc</pub><pmid>27664854</pmid><doi>10.1016/j.bcp.2016.09.019</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0006-2952 |
| ispartof | Biochemical pharmacology, 2016-12, Vol.122, p.33-41 |
| issn | 0006-2952 1873-2968 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1835397102 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Anti-drug antibodies Antibodies - blood Crohn Disease - blood Crohn Disease - drug therapy Crohn’s disease Electrophoretic Mobility Shift Assay - methods HMSA Humans Infliximab Infliximab - therapeutic use Prospective Studies |
| title | Standardization of the homogeneous mobility shift assay protocol for evaluation of anti-infliximab antibodies. Application of the method to Crohn’s disease patients treated with infliximab |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T12%3A26%3A01IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Standardization%20of%20the%20homogeneous%20mobility%20shift%20assay%20protocol%20for%20evaluation%20of%20anti-infliximab%20antibodies.%20Application%20of%20the%20method%20to%20Crohn%E2%80%99s%20disease%20patients%20treated%20with%20infliximab&rft.jtitle=Biochemical%20pharmacology&rft.au=Hern%C3%A1ndez-Breijo,%20B.&rft.aucorp=on%20behalf%20of%20the%20PREDICROHN%20study%20group%20from%20GETECCU&rft.date=2016-12-15&rft.volume=122&rft.spage=33&rft.epage=41&rft.pages=33-41&rft.issn=0006-2952&rft.eissn=1873-2968&rft_id=info:doi/10.1016/j.bcp.2016.09.019&rft_dat=%3Cproquest_cross%3E1835397102%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1835397102&rft_id=info:pmid/27664854&rft_els_id=S0006295216303021&rfr_iscdi=true |