Long-Term Clinical Outcomes After Switching from Remicade® to Biosimilar CT-P13 in Inflammatory Bowel Disease.
Dig Dis Sci
; 62(11): 3117-3122, 2017 11.
Article
en En
| MEDLINE
| ID: mdl-28667429
ABSTRACT
BACKGROUND:
Limited data are available on long-term clinical outcomes regarding the switch from Remicade® to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients.AIMS:
To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity.METHODS:
We performed a single-center prospective observational cohort study following an elective switch from Remicade® to CT-P13 in IBD patients.RESULTS:
Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up. Disease activity (Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index) as well as inflammatory markers (CRP, fecal calprotectin) did not change significantly during the 1-year follow-up. In total, 7 out of 83 patients (8%) demonstrated detectable antidrug antibodies during follow-up, and 5 out of 7 antidrug antibody titers were already detectable at baseline prior to switching. Six patients (7%) discontinued CT-P13 due to adverse events.CONCLUSIONS:
Following a switch from Remicade® to CT-P13, 82% of IBD patients continued treatment through 1 year. Disease activity scores and inflammatory markers remained unchanged during follow-up, and no CT-P13-related serious adverse events occurred. These 1-year data suggest that switching to CT-P13 in Remicade®-treated IBD patients is safe and feasible.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Fármacos Gastrointestinales
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Colitis Ulcerosa
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Enfermedad de Crohn
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Sustitución de Medicamentos
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Biosimilares Farmacéuticos
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Infliximab
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Anticuerpos Monoclonales
Tipo de estudio:
Diagnostic_studies
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Observational_studies
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
Dig Dis Sci
Año:
2017
Tipo del documento:
Article
País de afiliación:
Países Bajos