ABSTRACT
OBJECTIVE: Switching patients from the originator infliximab to a biosimilar is a measure to expand access to treatments and counteract its negative impact on healthcare budgets. However, industry-independent long-term studies on the effect of switching in real life to support the lack of switch-related problems in inflammatory bowel disease (IBD) patients are sparse, as are studies addressing infliximab pharmacokinetic behaviour. The objectives were to investigate the effectiveness and the pharmacokinetics of CT-P13 after switching from originator infliximab in a real-world population of IBD patients with a follow-up of 2 years. METHOD: Prospective, single-centre, observational 2 year study conducted in IBD adult patients with stable disease treated with the originator infliximab who were switched to CT-P13. Four time points were defined for follow-up: prior to the switch, 4-8 weeks after the switch, 8 months later, and 2 years later. Outcome measures were the proportion of patients with clinical, endoscopic and biochemical remission, and changes in biochemical inflammation markers (albumin, C-reactive protein, faecal calprotectin) and infliximab clearance. RESULTS: 42 IBD patients were switched, of which 36 (85.7%) remained on CT-P13 throughout the 2 year study period. Only two patients discontinued CT-P13 due to loss of response. The proportion of patients who displayed clinical, endoscopic and biochemical remission were unchanged during the follow-up (p<0.05) and no statistically significant changes were observed in the biochemical markers of disease activity. The median (IQR) clearance estimated for the infliximab originator before the change was 0.364 (0.321-0.415) L/day, and for the CT-P13 biosimilar it was 0.361 (0.323-0.415) L/day 4-8 weeks after the change, and 0.370 (0.334-0.419) L/day 2 years after (p=0.395). CONCLUSION: Switching from originator infliximab to biosimilar CT-P13 did not affect the long-term clinical outcomes or the pharmacokinetic behaviour. This information provides the clinician more evidence for the success of switching and supports non-medical switching in adult IBD patients.
Subject(s)
Biosimilar Pharmaceuticals , Inflammatory Bowel Diseases , Adult , Antibodies, Monoclonal , Biosimilar Pharmaceuticals/adverse effects , Drug Substitution , Gastrointestinal Agents , Humans , Inflammatory Bowel Diseases/chemically induced , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Prospective StudiesABSTRACT
OBJECTIVE: Evidence on the usefulness of proactive monitoring of vedolizumab serum concentrations during the induction phase of treatment is limited. The objective of our study was to evaluate the effectiveness of measuring such concentrations during this phase in predicting response to treatment in patients with ulcerative colitis with a view to determining whether patients would benefit from early monitoring of edolizumab serum concentrations. METHOD: This was a prospective descriptive study carried out at three public general hospitals. It included adult patients with ulcerative colitis who were initiated on vedolizumab at the participating hospitals from June 2019 to June 2020. Vedolizumab serum concentrations were determined at weeks 6 and 14. Response to treatment was biologically, clinically, and endoscopically evaluated at weeks 6, 14, and 52. An analysis was made of the relationship between vedolizumab serum concentrations at week 6 and early response to treatment, and of the relationship between the vedolizumab serum concentrations at weeks 6 and 14 and persistent response at one year. RESULTS: A total of 45 patients were included of whom 22 (49%) were considered non-responsive after one year and required intensification of treatment. The median (interquartile range) vedolizumab serum oncentrations obtained at 6 weeks was higher in patients who obtained an early response and in those who maintained the response at one year than in those who did not respond to vedolizumab [27.4 (19.0-40.8) µg/mL vs 15.6 (13.4-28.5) µg/mL; p = 0.018] and [29.9 (19.2-43.2) µg/mL vs 18.2 (15.4- 26.9) µg/mL; p = 0.022] respectively. Vedolizumab serum concentrations ≥ 17.3 µg/mL at week 6 were predictive of a good early response, and edolizumab serum concentrations ≥ 26.1 µg/mL at week 6 predicted a sustained response at one year. No relationship was found between edolizumab serum concentrations at week 14 and a sustained response. CONCLUSIONS: We observed a relationship between vedolizumab serum concentrations determined at week 6, and early and maintained esponse to vedolizumab therapy in patients with ulcerative colitis, which supports early drug monitoring during the induction phase to individualize treatment and increase effectiveness.
OBJETIVO: La evidencia sobre la utilidad de la monitorización proactiva de las concentraciones séricas de vedolizumab en la fase de inducción del tratamiento es limitada. El objetivo del estudio ha sido evaluar la capacidad de las concentraciones séricas de vedolizumab determinadas en esta fase para predecir la respuesta al tratamiento en pacientes con colitis ulcerosa, con el fin de establecer si los pacientes se beneficiarían clínicamente de una monitorización precoz.Método: Estudio descriptivo, prospectivo, realizado en tres hospitales generales públicos. Incluyó a los pacientes adultos con colitis ulcerosa, que iniciaron tratamiento con vedolizumab en los centros participantes desde junio de 2019 a junio de 2020. Se determinaron las concentraciones séricas de vedolizumab en las semanas 6 y 14 de tratamiento. La respuesta bioquímica, clínica y endoscópica se evaluó en las semanas 6, 14 y 52. Se estudió la relación de las concentraciones séricas de vedolizumab determinadas en la semana 6 con la respuesta temprana al tratamiento, así como la relación de las concentraciones séricas de vedolizumab en las semanas 6 y 14 con la persistencia de respuesta al año de tratamiento. RESULTADOS: Se incluyeron 45 pacientes, de los que 22 (49%) se consideraron no respondedores al cabo de un año y necesitaron intensificar el tratamiento. Las medianas (rango intercuartílico) de las concentraciones séricas de vedolizumab en la semana 6 fueron superiores, tanto en los pacientes que presentaron respuesta temprana como en los que mantuvieron respuesta al cabo de un año, comparadas con las de los pacientes que no respondieron a vedolizumab [27,4 (19,0-40,8) µg/ml vs 15,6 (13,428,5) µg/ml; p = 0,018] y [29,9 (19,2-43,2) µg/ml vs 18,2 (15,426,9) µg/ml; p = 0,022], respectivamente. Las concentraciones séricas de vedolizumab ≥ 17,3 µg/ml en la semana 6 predijeron una buena respuesta temprana, y concentraciones séricas de vedolizumab ≥ 26,1 µg/ml en la emana 6 predijeron una respuesta mantenida al cabo de un año. No se encontró relación entre las concentraciones séricas de vedolizumab en la semana 14 y la respuesta mantenida. CONCLUSIONES: Se ha observado una relación entre las concentraciones séricas de vedolizumab determinadas en la semana 6 y la respuesta temprana y mantenida a la terapia en pacientes con colitis ulcerosa, lo que avala la monitorización precoz durante la fase de inducción, para individualizar el tratamiento y aumentar su eficacia.
Subject(s)
Colitis, Ulcerative , Adult , Antibodies, Monoclonal, Humanized , Colitis, Ulcerative/drug therapy , Humans , Prospective StudiesABSTRACT
Objetivo: La evidencia sobre la utilidad de la monitorización proactiva delas concentraciones séricas de vedolizumab en la fase de inducción del tratamiento es limitada. El objetivo del estudio ha sido evaluar la capacidad delas concentraciones séricas de vedolizumab determinadas en esta fase parapredecir la respuesta al tratamiento en pacientes con colitis ulcerosa, con el finde establecer si los pacientes se beneficiarían clínicamente de una monitorización precoz.Método: Estudio descriptivo, prospectivo, realizado en tres hospitalesgenerales públicos. Incluyó a los pacientes adultos con colitis ulcerosa, queiniciaron tratamiento con vedolizumab en los centros participantes desdejunio de 2019 a junio de 2020. Se determinaron las concentraciones séricas de vedolizumab en las semanas 6 y 14 de tratamiento. La respuestabioquímica, clínica y endoscópica se evaluó en las semanas 6, 14 y 52.Se estudió la relación de las concentraciones séricas de vedolizumab determinadas en la semana 6 con la respuesta temprana al tratamiento, asícomo la relación de las concentraciones séricas de vedolizumab en lassemanas 6 y 14 con la persistencia de respuesta al año de tratamiento. (AU)
Objective: Evidence on the usefulness of proactive monitoring of vedolizumab serum concentrations during the induction phase of treatment islimited. The objective of our study was to evaluate the effectiveness ofmeasuring such concentrations during this phase in predicting responseto treatment in patients with ulcerative colitis with a view to determiningwhether patients would benefit from early monitoring of vedolizumabserum concentrations.Method: This was a prospective descriptive study carried out at threepublic general hospitals. It included adult patients with ulcerative colitiswho were initiated on vedolizumab at the participating hospitals from June2019 to June 2020. Vedolizumab serum concentrations were determined at weeks 6 and 14. Response to treatment was biologically, clinically,and endoscopically evaluated at weeks 6, 14, and 52. An analysis wasmade of the relationship between vedolizumab serum concentrations atweek 6 and early response to treatment, and of the relationship betweenthe vedolizumab serum concentrations at weeks 6 and 14 and persistentresponse at one year. (AU)