{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:35:28Z","timestamp":1761863728749,"version":"3.38.0"},"reference-count":45,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,8,11]],"date-time":"2017-08-11T00:00:00Z","timestamp":1502409600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> 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\u2019s rank coefficients (range 0.890\u20130.947) and intraclass correlation coefficients (range 0.907\u20130.935). 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\u20134 \u00b5g\/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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p> Our results indicate that three of the tested IFX quantification methods can be used to accurately quantify CT-P13 without any adjustments. <\/jats:p><\/jats:sec>","DOI":"10.1177\/1756283x17722915","type":"journal-article","created":{"date-parts":[[2017,8,11]],"date-time":"2017-08-11T11:43:47Z","timestamp":1502451827000},"page":"661-671","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":15,"title":["Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays"],"prefix":"10.1177","volume":"10","author":[{"given":"Joana","family":"Afonso","sequence":"first","affiliation":[{"name":"Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal"},{"name":"MedInUP, Centre for Drug Discovery and Innovative Medicines, University of Porto, 4200 Porto, Portugal"}]},{"given":"Helena Tavares","family":"de Sousa","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, Algarve Hospital Centre, Portugal"},{"name":"Biomedical Sciences and Medicine Department, University of Algarve, Portugal"},{"name":"ABC (Algarve Biomedical Centre), University of Algarve, Portugal"}]},{"given":"Isadora","family":"Rosa","sequence":"additional","affiliation":[{"name":"Gastroenterology Department, Instituto Portugu\u00eas de Oncologia de Lisboa, Lisboa, Portugal"}]},{"given":"Jo\u00e3o","family":"Carvalho","sequence":"additional","affiliation":[{"name":"Department of 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