dc.creator | Argüelles Arias, Federico | es |
dc.creator | Guerra Veloz, María Fernanda | es |
dc.creator | Perea Amarillo, Raúl | es |
dc.creator | Vilches Arenas, Ángel | es |
dc.creator | Castro Laria, Luisa | es |
dc.creator | Maldonado Pérez, Belén | es |
dc.creator | Merino Bohórquez, Vicente | |
dc.creator | Romero Gómez, Manuel | |
dc.date.accessioned | 2019-02-26T18:25:36Z | |
dc.date.available | 2019-02-26T18:25:36Z | |
dc.date.issued | 2017 | |
dc.identifier.citation | Argüelles Arias, F., Guerra Veloz, M.F., Perea Amarillo, R., Vilches Arenas, Á., Castro Laria, L., Maldonado Pérez, B.,...,Romero Gómez, M. (2017). Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results. European Journal of Gastroenterology & Hepatology, 29 (11), 1290-1295. | |
dc.identifier.issn | 1473-5687 | es |
dc.identifier.uri | https://hdl.handle.net/11441/83530 | |
dc.description.abstract | Background: 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.format | application/pdf | es |
dc.language.iso | eng | es |
dc.publisher | Lippincott Williams & Wilkins | es |
dc.relation.ispartof | European Journal of Gastroenterology & Hepatology, 29 (11), 1290-1295. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Biosimilar agent | es |
dc.subject | Crohn’s disease | es |
dc.subject | CT-P13 | es |
dc.subject | Inflammatory bowel disease | es |
dc.subject | Infliximab | es |
dc.subject | Ulcerative colitis | es |
dc.title | Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.identifier.doi | 10.1097/MEG.0000000000000953 | es |
dc.contributor.group | Universidad de Sevilla. CTS-532 Unidad de Hepatologia | es |
idus.format.extent | 6 | es |
dc.journaltitle | European Journal of Gastroenterology & Hepatology | es |
dc.publication.volumen | 29 | es |
dc.publication.issue | 11 | es |
dc.publication.initialPage | 1290 | es |
dc.publication.endPage | 1295 | es |