Search

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.

Introduccion: la endoscopia tiene un papel fundamental en el manejo de los pacientes con colitis ulcerosa (CU), ya que permite la visualizacion y evaluacion de la gravedad de la enfermedad. No obstante, dicha evaluacion no es siempre algo objetivo, por lo que se han desarrollado diferentes escalas que pretenden homogeneizar los hallazgos. Objetico: el objetivo del estudio fue evaluar la variabilidad interobservador entre el Indice de Mayo Endoscopico (IME) y el Indice de Severidad Endoscopica de la Colitis Ulcerosa (UCEIS), al analizar la gravedad de las lesiones endoscopicas en pacientes con CU. El objetivo secundario fue analizar si la preparacion catartica afectaba al grado de concordancia entre los endoscopistas. Material y metodos: se trata de un estudio observacional comparativo de una unica cohorte a la cual se realiza una colonoscopia bajo guia de practica clinica habitual a pacientes con CU y se estadifica segun el IME y el UCEIS por tres endoscopistas expertos. Para valorar el grado de correlacion interobservador se utilizaron el indice de Kappa para el IME y el coeficiente de correlacion intraclase para el UCEIS. Se incluyeron 67 pacientes, con edad media de 51 anos (DE ± 16,7) e indice de Mayo clinico medio de 3,07 (DE ± 2,54). Resultados: el indice de Kappa ponderado entre los endoscopistas A y B para el IME fue de 0,8; entre el A y el C, de 0,52; y entre el B y el C, de 0,49. Para el UCEIS, el coeficiente de correlacion intraclase fue del 0,922 entre los tres endoscopistas (IC 95 %: 0,832-0,959). Se encontro una mejor correlacion interobservador cuando la preparacion catartica era ≥ 8 segun la escala de Boston. Conclusion: existe, por tanto, una superior correlacion entre los diferentes endoscopistas para el UCEIS que para el IME, por lo que deberia ser considerado como el mejor indice a utilizar en la practica clinica. Una buena preparacion catartica es importante para mejorar la correlacion interobservador.

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD. METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar. RESULTS 98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar (P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar (P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.