Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. reference infliximab in inflammatory bowel disease: A retrospective cohort study

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.

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.