Artículo
Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results
Autor/es | Argüelles Arias, Federico
Guerra Veloz, María Fernanda Perea Amarillo, Raúl Vilches Arenas, Ángel Castro Laria, Luisa Maldonado Pérez, Belén Merino Bohórquez, Vicente Romero Gómez, Manuel |
Departamento | Universidad de Sevilla. Departamento de Medicina |
Fecha de publicación | 2017 |
Fecha de depósito | 2019-02-26 |
Publicado en |
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Resumen | 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 ... 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. |
Cita | 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. |
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Switching.pdf | 219.6Kb | [PDF] | Ver/ | Swithching |