P487 Effectiveness and safety of CT-P13 under routine care in paediatric patients with inflammatory bowel disease

Abstract

Background: Biosimilar to innovator infliximab (INX), CT-P13, has been approved for all indications including paediatric patients with inflammatory bowel disease (IBD) by the European Medicines Agency in 2013 and Food and Drug Administration in 2016. Ob-servational study has been conducted for paediatric patients with Crohn's disease (CD) or Ulcerative colitis (UC) at 10 study centres in South Korea. Methods: Paediatric CD and UC patients were classified as naïve patients or switch patients defined by history of treatment with anti-TNF agents prior to receiving CT-P13. For CD patients, remission was defined by Paediatric Crohn's Disease Activity Index (PCDAI) score of less than 10 (Hyams et al. 2005 [1]). For UC patients, remission was defined by Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (Turner et al. 2012 [2]). Effectiveness was considered as post-baseline remission if at least one remission was achieved throughout Week 2 to 30. Results: A total of 51 paediatric patients with CD (26 naïve patients and 25 switch patients) and 23 paediatric patients with UC (16 naïve and 7 switch patients) were included. Paediatric CD population consisted of 25 male and 26 female patients with mean age of 14.3±2.4 years. For paediatric UC, 11 male and 12 female patients were included with mean age of 13.6±3.0 years. At baseline, disease status of naïve patients was 4 times higher than switch patients when comparing baseline PCDAI or PUCAI score. The proportion of patients achieving post-baseline remission was 87.5% (21/24) and 80.0% (12/15) for naïve CD and UC patients, respectively. For switch group, post-baseline remission was achieved in 86.4% (19/22) and 100.0% (7/7) of CD and UC patients, respectively. Overall, 2 (6.3% [2/32]) switch patients experienced at least 1 related treatment-emergent adverse event (TEAE) (for CD, 4.0% [1/25]; for UC, 14.3% [1/7]). And no related TEAE was observed in naïve patients. There were total 4 (9.5% [4/42]) naive patients and 1 (3.1% [1/32]) switch patient reported treatment-emergent serious adverse event (TESAE) but none of them were considered related to treatment by investigator. Infusion-related reaction was reported in 1 (3.1% [1/32]) switch patient and there were no cases from naïve patients. Conclusions: CT-P13 in both naïve and switch paediatric patients with IBD was effective over 30 weeks. The safety of CT-P13 was favourable and product was well tolerated in paediatric IBD popula-tion.