Real-world data on the infliximab biosimilar CT-P13 (Remsima (R)) in inflammatory bowel disease
Por:
Huguet JM, Cortés X, Bosca-Watts MM, Aguas M, Maroto N, Martí L, Amorós C and Paredes JM
Publicada:
26 dic 2021
Categoría:
Medicine (miscellaneous)
Resumen:
BACKGROUND
In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients' access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD.
AIM
To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice.
METHODS
An observational, prospective, multicenter study of IBD patients treated with CT-P13 in clinical practice who were naive to biological treatments or failed to respond to other anti-tumor necrosis factor drugs or had switched from infliximab originator was carried out. No diagnostic or follow-up interventions were conducted on patients outside usual clinical practice. The primary endpoints were clinical response rates and number of adverse events. The primary efficacy variable was the proportion of patients who were in clinical remission and/or had a clinical response at 3, 6, 9, and 12 mo.
RESULTS
A total of 220 IBD patients treated with CT-P13 (Remsima (R)) were included in the study: 87 (40%) with ulcerative colitis and 133 (60%) with Crohn's disease. Mean age of the patients was 41.47 (SD 15.74) years, and 58% were female. Nineteen (9%) patients started treatment with CT-P13 after switching from infliximab. Of the remaining 201 patients, 142 (65%) were naive to biologic agents. At baseline, 68.6% (n = 138/201) of patients presented with active disease. After 12 mo of treatment, 14.8% (n = 12/81) presented with active disease, and 64.2% (n = 52/81) were in clinical remission without corticosteroids. After 3 mo, 75.5% (n = 115/152) had a clinical response or achieved clinical remission, which was sustained for 12 mo (85.2%; n = 69/81). There was a decrease in specific IBD indices at 3, 6, 9, and 12 mo (P < 0.001). A total of 34 adverse events were reported by 27 (12.3%) patients, 9 (26.5%) of which were serious.
CONCLUSION
CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD in real-life practice and may be a valid and attractive alternative for the treatment of IBD.
Filiaciones:
Huguet JM:
Department of Gastroenterology, General University Hospital of Valencia, Valencia 46014, Spain.
:
Department of Gastroenterology, Hospital de Sagunto, Sagunto 46520, Spain
Bosca-Watts MM:
Department of Gastroenterology, Hospital Clinico Universitario de Valencia, Valencia 46010, Spain
Aguas M:
Department of Gastroenterology, Hospital Universitario y Politecnico la Fe de Valencia, Valencia 46026, Spain
Maroto N:
Department of Gastroenterology, Hospital de Manises, Manises 46940, Spain
:
Department of Gastroenterology, Hospital Comarcal Francesc de Borja, Gandia 46702, Spain
:
Department of Gastroenterology, Hospital Arnau de Vilanova de Valencia, Valencia 46015, Spain
:
Department of Gastroenterology, Hospital Universitario Doctor Peset de Valencia, Valencia 46017, Spain
Green Published, gold
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