Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease.
J Pediatr Gastroenterol Nutr
; 65(3): 285-288, 2017 09.
Article
em En
| MEDLINE
| ID: mdl-28542043
ABSTRACT
INTRODUCTION:
In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn disease (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients.METHODS:
Thirty-six CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13 were enrolled in this prospective, observational study. Patients received 3 induction doses (5âmg/kg) of CT-P13 at weeks 0, 2, 6. Assessment was performed before the first infusion and at week 14.RESULTS:
Overall 34/36 (94.4%) patients completed induction therapy with CT-P13. A clinical response or remission after 3 initial doses was achieved in 31/36 (86%) and 24/36 (67%) of patients, respectively. Clinically and statistically significant decreases in Paediatric Crohn's Disease Activity Index, C-reactive protein, and erythrocyte sedimentation rate were observed in the responders group. An allergic reaction during infusion, which led to treatment discontinuation, was observed in one case.CONCLUSIONS:
Induction therapy with CT-P13 in children with CD is effective. The profile appears similar to that reported for the reference infliximab. No unexpected adverse events occurred.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Fármacos Gastrointestinais
/
Doença de Crohn
/
Medicamentos Biossimilares
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Quimioterapia de Indução
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Anticorpos Monoclonais
Tipo de estudo:
Clinical_trials
/
Observational_studies
Limite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Revista:
J Pediatr Gastroenterol Nutr
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Polônia