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Effectiveness and Safety of Switching from Innovator Infliximab to Biosimilar CT-P13 in Inflammatory Rheumatic Diseases: A Real-World Case Study

OBJECTIVE: CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment. METHODS: In this retrospective real-world study, patients w...

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Detalles Bibliográficos
Autores principales: Vergara-Dangond, Cristina, Sáez Belló, Marina, Climente Martí, Mónica, Llopis Salvia, Pilar, Alegre-Sancho, Juan José
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5629134/
https://www.ncbi.nlm.nih.gov/pubmed/28667384
http://dx.doi.org/10.1007/s40268-017-0194-8
Descripción
Sumario:OBJECTIVE: CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment. METHODS: In this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n = 6). Clinical outcomes were compared between groups after four treatment cycles. RESULTS: CT-P13 demonstrated comparable effectiveness to its RP. All patients who switched to the biosimilar maintained or improved their clinical response, including two who remained in remission and three who moved into remission. In the RP group, five patients maintained their clinical response, with one achieving remission. Safety profiles were similar between groups. CONCLUSIONS: CT-P13 was equally effective as infliximab RP in this real-world study. CT-P13 is a valid, lower-cost alternative for patients currently receiving RP.