Induction therapy with biosimilar infliximab in children with Crohn's disease
Journal of Pediatric Gastroenterology and Nutrition Aug 30, 2017
Sieczkowska–Golub J, et al. – The similarity between an infliximab biosimilar (CT–P13) and the originator infliximab in induction therapy were evaluated in Crohn's disease (CD) paediatric patients. In children with CD, induction therapy with CT–P13 was effective. The profile appeared comparable to that reported for the reference infliximab. There were no unexpected adverse events.
Methods- The researchers enrolled 36 CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13 in this prospective, observational study.
- For this study, patients received 3 induction doses (5 mg/kg) of CT-P13 at weeks 0, 2, 6.
- They performed the assessment before the first infusion and at week 14.
- In this study, 34 out of 36 (94.4%) patients completed induction therapy with CT-P13.
- The researchers achieved a clinical response or remission after 3 initial doses in 31 out of 36 (86%) and 24 out of 36 (67%) of patients, respectively.
- They observed clinically and statistically significant decreases in Paediatric Crohn's Disease Activity Index, C-reactive protein, and erythrocyte sedimentation rate in the responders group.
- During infusion, they observed an allergic reaction in 1 case which led to treatment discontinuation.
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