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dc.creatorArgüelles Arias, Federicoes
dc.creatorGuerra Veloz, María Fernandaes
dc.creatorPerea Amarillo, Raúles
dc.creatorVilches Arenas, Ángeles
dc.creatorCastro Laria, Luisaes
dc.creatorRomero Gómez, Manueles
dc.date.accessioned2019-02-26T18:25:36Z
dc.date.available2019-02-26T18:25:36Z
dc.date.issued2017
dc.identifier.issn1473-5687es
dc.identifier.urihttps://hdl.handle.net/11441/83530
dc.description.abstractBackground: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. Materials and methods: This was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. Results: A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P =0.007) but no significant change was observed in median CRP at this timepoint (P= 0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P =0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Conclusion: Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.es
dc.formatapplication/pdfes
dc.language.isoenges
dc.publisherLippincott Williams & Wilkinses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectBiosimilar agentes
dc.subjectCrohn’s diseasees
dc.subjectCT-P13es
dc.subjectInflammatory bowel diseasees
dc.subjectInfliximabes
dc.subjectUlcerative colitises
dc.titleSwitching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months resultses
dc.typeinfo:eu-repo/semantics/articlees
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessrightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.identifier.doi10.1097/MEG.0000000000000953es
dc.contributor.groupUniversidad de Sevilla. CTS-532 Unidad de Hepatologiaes
idus.format.extent6es
dc.journaltitleEuropean Journal of Gastroenterology & Hepatologyes
dc.publication.volumen29es
dc.publication.issue11es
dc.publication.initialPage1290es
dc.publication.endPage1295es

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