Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

BACKGROUND: Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. METHODS: OoL and clinical efficacy were measured prior to an...

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Detalles Bibliográficos
Autores principales: Pierik, Marieke J, van der Meulen, Andrea E, Van der Linde, Klaas, Lutgens, Maurice, Kuijvenhoven, Johan P, Akol, Halil, Klompmaker, Ids J, Sikkens, Michelle S G, van Megen, Yvonne J B, Stoop, Corinne M, Bloemsaat-Minekus, Joanne P J, Dijkstra, Gerard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Observations and Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802295/
https://www.ncbi.nlm.nih.gov/pubmed/36777418
http://dx.doi.org/10.1093/crocol/otab001
Descripción
Sumario:BACKGROUND: Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. METHODS: OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. RESULTS: One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference −0.02 (95% confidence interval −0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events. CONCLUSIONS: Switching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

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