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Inicio Gastroenterología y Hepatología (English Edition) Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. ...
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Vol. 47. Issue 6.
Pages 553-561 (June - July 2024)
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Vol. 47. Issue 6.
Pages 553-561 (June - July 2024)
Original article
Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. reference infliximab in inflammatory bowel disease: A retrospective cohort study
Comparación de efectividad y persistencia del infliximab biosimilar CPT-13 versus infliximab de referencia en la enfermedad inflamatoria intestinal: Un estudio de cohorte retrospectivo
Lidia Serrano Díaza,d, Carles Iniesta Navalónb,d,
Corresponding author
carles.iniesta@carm.es

Corresponding author.
, Rosa Gómez Espína,d, Isabel Nicolás De Pradoa,d, Enrique Bernal Morellc,d, Lorena Rentero Redondob
a Department of Gastroenterology, Reina Sofia Hospital of Murcia, Spain
b Department of Hospital Pharmacy, Reina Sofia Hospital of Murcia, Spain
c Department of Infectious Disease, Reina Sofia Hospital of Murcia, Spain
d Biomedical Research Institute of Murcia (IMIB-Pascual Parrilla), University Clinical Hospital Virgen de la Arrixaca, Murcia, Spain
Article information
Abstract
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Figures (2)
Tables (5)
Table 1. Patient characteristics at baseline.
Table 2. Patient characteristics in the TDM and non-TDM group.
Table 3. Bivariate and multivariate analysis of the predictors of infliximab survival.
Table 4. Main outcomes during follow-up period in TDM subgroup.
Table 5. Factors associated with poor outcomes at week 26 and 52.
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Additional material (2)
Abstract
Background

Studies have investigated the efficacy and safety of switching to the biosimilar infliximab (CT-P13) in patients with inflammatory bowel disease (IBD). However, there is limited research directly comparing the effectiveness, drug survival, and pharmacokinetic profiles of the reference infliximab (IFX) and CT-P13 in real clinical settings.

Objective

To compare the effectiveness and drug survival of CPT-13 and reference IFX at weeks 26 and 52, and to determine the pharmacokinetic profiles and safety profile in real-world settings.

Methods

A retrospective observational cohort analysis was conducted at a single center. The study compared the proportion of patients achieving clinical remission and experiencing poor clinical outcomes at weeks 26 and 52. The drug survival rate of CT-P13 and reference infliximab was also assessed during the follow-up period.

Results

A total of 153 patients were included in the study, 39.2% receiving CPT-13 and 60.8% reference IFX. At week 26, clinical remission rates were 66.7% (CPT-13: 74.4% vs. reference IFX: 62.3%, p=0.178), and at week 52, they were 64% (CPT-13: 85.4% vs. reference IFX: 63.0%, p=0.012). Subgroup analysis with therapeutic drug monitoring (TDM) found no significant differences at week 26 (CPT-13: 74.4% vs. reference IFX: 58.8%, p=0.235) or at week 52 (CPT-13: 85.4% vs. reference IFX: 68.8%, p=0.153).

Conclusion

Our study demonstrates comparable efficacy, drug survival, pharmacokinetic profiles, and incidence of immunogenicity between both drugs in a real clinical setting. Further studies with greater statistical power are needed to validate these findings.

Keywords:
Infliximab
Inflammatory bowel disease
Biosimilar
Anti-drug antibody
Pharmacokinetic
Drug survival
Abbreviations:
TNF-α
CD
UC
IBD
IFX
ITL
TDM
BMI
mHBI
ATI
ELISA
Resumen
Antecedentes

Existen escasos estudios de cohortes que comparan la efectividad y la persistencia en vida real de infliximab biosimial (CPT-13) e IFX original.

Objetivo

Comparar la efectividad y persistencia de CPT-13 e IFX original en las semanas 26 y 52, así como el perfil farmacocinético y de seguridad en vida real.

Métodos

Se realizó un análisis de cohorte observacional retrospectivo. El estudio comparó la proporción de pacientes que lograron la remisión clínica y experimentaron malos resultados clínicos en las semanas 26 y 52. También se evaluó la tasa de supervivencia del medicamento CT-P13 e infliximab de referencia durante el período de seguimiento.

Resultados

Un total de 153 pacientes fueron incluidos en el estudio, con 60 (39.2%) recibiendo IFX biosimilar y 93 (60.8%) recibiendo IFX de referencia. A la semana 26, las tasas de remisión clínica fueron del 66.7% (CPT-13: 74.4% vs. IFX de referencia: 62.3%, p = 0.178), y a la semana 52, fueron del 64% (CPT-13: 85.4% vs. IFX de referencia: 63.0%, p = 0.012). El análisis de subgrupos de pacientes en monitorización de concentraciónes séricas (TDM) no mostró diferencias significativas en la semana 26 (CPT-13: 74.4% vs. IFX de referencia: 58.8%, p = 0.235) ni en la semana 52 (CPT-13: 85.4% vs. IFX de referencia: 68.8%, p = 0.153).

Conclusiones

Nuestro estudio demuestra una efectividad, persistencia comparable, supervivencia del medicamento, perfiles farmacocinéticos e incidencia de inmunogenicidad entre CPT-13 e infliximab de referencia en un entorno clínico real. Se necesitan estudios adicionales con mayor poder estadístico para validar estos hallazgos.

Palabras clave:
Infliximab
Enfermedad inflamatoria intestinal
Biosimilar
Anticuerpo anti-infliximab
Farmacocinética
Persistencia

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