{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T13:37:06Z","timestamp":1753882626972,"version":"3.41.2"},"reference-count":25,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Portuguese IBD Group"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> The advent of Remicade\u00ae biosimilars, Remsima\u00ae, Inflectra\u00ae and, more recently, Flixabi\u00ae, has brought along the potential to decrease the costs associated with this therapy, therefore increasing its access to a larger group of patients. However, and in order to assure a soft transition, one must make sure the assays and algorithms previously developed and optimized for Remicade perform equally well with its biosimilars. This study aimed to: (a) validate the utilization of Remicade-optimized therapeutic drug monitoring assays for the quantification of Flixabi; and (b) determine the existence of Remicade, Remsima and Flixabi cross-immunogenicity. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Healthy donors\u2019 sera spiked with Remicade, Remsima and Flixabi were quantified using three different Remicade-quantification assays, and the reactivity of anti-Remicade and anti-Remsima sera to Remicade and to its biosimilars was assessed. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> The results show that all tested Remicade-infliximab-optimized assays measure Flixabi as accurately as they measure Remicade and Remsima: the intraclass correlation coefficients between theoretical and measured concentrations varied from 0.920 to 0.990. Moreover, the interassay agreement values for the same compounds were high (intraclass correlation coefficients varied from 0.936 to 0.995). Finally, the anti-Remicade and anti-Remsima sera reacted to the different drugs in a similar fashion. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p> The tested assays can be used to monitor Flixabi levels. Moreover, Remicade, Remsima and Flixabi were shown to have a high cross-immunogenicity, which supports their high similarity but prevents their switching in nonresponders with antidrug antibodies. <\/jats:p><\/jats:sec>","DOI":"10.1177\/1756284818796956","type":"journal-article","created":{"date-parts":[[2018,9,24]],"date-time":"2018-09-24T06:05:41Z","timestamp":1537769141000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["The performance of Remicade\u00ae-optimized quantification assays in the assessment of Flixabi\u00ae levels"],"prefix":"10.1177","volume":"11","author":[{"given":"F.","family":"Magro","sequence":"first","affiliation":[{"name":"Department of Biomedicine, Pharmacology and Therapeutics Unit, Faculty of Medicine, University of Porto, Alameda Prof. Hern\u00e2ni Monteiro, 420-319 Porto, Portugal"},{"name":"Gastroenterology Department, Centro Hospitalar S\u00e3o Jo\u00e3o, Porto, Portugal"},{"name":"MedInUP, Centre for Drug Discovery and Innovative Medicines, Porto, Portugal"}]},{"given":"C.","family":"Rocha","sequence":"additional","affiliation":[{"name":"Department of Biomedicine, University of Porto, Porto, Portugal"},{"name":"Faculty of Medicine, University of Lisbon, Lisbon, Portugal"}]},{"given":"A. I.","family":"Vieira","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hospital Garcia de Orta, Almada, Portugal"}]},{"given":"H. T.","family":"Sousa","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, Centro Hospitalar do Algarve, Portim\u00e3o, Portugal"},{"name":"Biomedical Sciences and Medicine Department, University of Algarve, Faro, Portugal"},{"name":"Algarve Biomedical Centre, University of Algarve, Faro, Portugal"}]},{"given":"I.","family":"Rosa","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, Instituto Portugu\u00eas de Oncologia de Lisboa, Lisboa, Portugal"}]},{"given":"S.","family":"Lopes","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, Centro Hospitalar S\u00e3o Jo\u00e3o, Porto, Portugal"}]},{"given":"J.","family":"Carvalho","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Centro Hospitalar de Gaia, Gaia, Portugal"}]},{"given":"C. C.","family":"Dias","sequence":"additional","affiliation":[{"name":"Health Information and Decision Sciences Department, University of Porto, Porto, Portugal"},{"name":"Centre for Health Technology and Services Research, Porto, Portugal"}]},{"given":"J.","family":"Afonso","sequence":"additional","affiliation":[{"name":"Department of Biomedicine, University of Porto, Porto, Portugal"},{"name":"Centre for Drug Discovery and Innovative Medicines, University of Porto, Porto, Portugal"},{"name":"MedInUP, Centre for Drug Discovery an Innovative Medicines, Porto, Portugal"}]}],"member":"179","published-online":{"date-parts":[[2018,9,23]]},"reference":[{"key":"bibr1-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjw053"},{"key":"bibr2-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2008.155812"},{"key":"bibr3-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1586\/17474124.2016.1096198"},{"key":"bibr4-1756284818796956","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200746080-00002"},{"key":"bibr5-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1097\/MOG.0000000000000184"},{"key":"bibr6-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1586\/17474124.2015.1091307"},{"key":"bibr7-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-016-0206-1"},{"key":"bibr8-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1038\/nrgastro.2016.155"},{"key":"bibr9-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1007\/s11894-014-0378-0"},{"key":"bibr10-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1586\/17512433.2016.1133288"},{"issue":"6","key":"bibr11-1756284818796956","first-page":"697","volume":"11","author":"Gonczi L","year":"2016","journal-title":"J Crohns Colitis"},{"key":"bibr12-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X17722915"},{"key":"bibr13-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13757"},{"key":"bibr14-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1177\/1756283X16658223"},{"key":"bibr15-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2009.201533"},{"key":"bibr16-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2014.07.029"},{"key":"bibr17-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2015.10.025"},{"key":"bibr18-1756284818796956","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v21.i6.1907"},{"key":"bibr19-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000000855"},{"key":"bibr20-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2015.09.005"},{"key":"bibr21-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2016.06.011"},{"key":"bibr22-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000000709"},{"key":"bibr23-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13402"},{"key":"bibr24-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-014-0094-1"},{"key":"bibr25-1756284818796956","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2015-309290"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756284818796956","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1756284818796956","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756284818796956","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,2]],"date-time":"2025-03-02T23:34:58Z","timestamp":1740958498000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1756284818796956"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,1]]},"references-count":25,"alternative-id":["10.1177\/1756284818796956"],"URL":"https:\/\/doi.org\/10.1177\/1756284818796956","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"type":"print","value":"1756-2848"},{"type":"electronic","value":"1756-2848"}],"subject":[],"published":{"date-parts":[[2018,1]]},"article-number":"1756284818796956"}}