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

Choe Y.H.*1, Yang H.R.2, Moon J.S.3, Ryoo E.4, Kim S.5, Lee J.H.6, Kim H.J.7, Park J.H.8, Kim M.J.9, Lee S.J.10, Lee S.Y.10

1Samsung medical center, Sungkyunkwan University School of Medicine, Department of Pediatrics, Seoul, South Korea 2Seoul National University Bundang Hospital, Department of Pediatrics, Seongnam, South Korea 3Seoul National University Hospital, Seoul, South Korea 4Gachon University Gil Medical center, Incheon, South Korea 5Severance Children's Hospital, Yonsei University College of Medicine, Department of Pediatrics, Seoul, South Korea 6Seoul Song Do Colorectal Hospital, Department of Internal Medicine, Seoul, South Korea 7Kyung Hee University College of Medicine, Department of Internal Medicine, Seoul, South Korea 8Pusan National University Yangsan Hospital, Pusan, South Korea 9Inje University Ilsan Paik Hospital, Department of Pediatrics, Goyang, South Korea 10CELLTRION, Inc., Incheon, South Korea

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. Observational 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.

Conclusion

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 population.

References:

[1] Hyams et al. (2005), Evaluation of the Pediatric Crohn Disease Activity Index: A prospective Multicenter Experience, JPGN, 41:416–421

[2] Turners et al. (2012), Management of Pediatric Ulcerative Colitis: Joint ECCO and ESPGHAN Evidence-based Consensus Guidelines, JPGN, 55: 340–361