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* = Presenting author

P329 Infliximab biosimilar in the treatment of inflammatory bowel disease: a Japanese single-cohort observational study

S. Hamanaka*, T. Nakagawa, H. Koseki, T. Sakurai, T. Taida, K. Okimoto, K. Saito, D. Maruoka, T. Matsumura, T. Katsuno, M. Arai, O. Yokosuka

Graduate School of Medicine, Chiba University, Department of Gastroenterology and Nephrology, Chiba City, Japan

Background

In Japan, infliximab biosimilar, infliximab BS intravenous agent NK® (IFXBS) which was co-developed by Celltrion and Nihonkayaku, was approved on July 2014. Since January 2015, we have used IFXBS for all patients with inflammatory bowel disease (IBD) when the patients need induction therapy using intravenous infusion of anti-tissue necrotic factor alpha. This is the first report of a single-Centre cohort study in Japan about the patients with IBD treated with IFXBS.

Methods

We evaluated the efficacy and safety of IFXBS in a single-cohort analysis in 20 patients with IBD who were received IFXBS in our hospital from January to October 2015. The process of IFXBS induction therapy is completely same as the original biologics, Remicade® the infusion timing, 3 times within 6 weeks (at week 0, 2, and 6). We assessed the efficacy of IFXBS by Lichtiger’s Index Score (LIS) for the patient with ulcerative colitis (UC) and by Crohn’s Disease Activity Index (CDAI) for the patient with Crohn’s disease (CD) at week 6 and 22. Achievement of remission was defined that LIS was less than 3 points for UC patients and CDAI was less than 150 points for CD patients. The patients who were treated with Remicade® maintenance therapy on schedule every 8 weeks, were recruited as biologics switch from Remicade® to IFXBS (Switch group), and the clinical alteration was confirmed at week 24 after administration of IFXBS.

Results

In patients with IBD (n = 20), 11 patients with UC and 6 patients with CD received remission-induction therapy and the switch group included 3 patients (1 with UC and 2 with CD). Mean age was 42.85 years (range, 16–74), 55% (n = 11) were male, and mean disease duration was 88.45 months (range, 13–72). In addition, 70% (n = 14) of the patients were bio-naïve and 10% (n = 2) were steroid naïve. We could observe 6 patients with UC and 4 patients with CD up to week 22, and each one patient with UC and CD was the switch case. Amongst the patients received remission-induction therapy, 46% of UC (n = 5) and 83% of CD (n = 5) patients achieved remission at week 6, and 80% of UC (n = 4) and 100% of CD (n = 3) patients achieved at week 22. Infusion reaction occurred in only one patient with CD (female patient who received remission-induction therapy) and she continued this therapy by premedication with hydrocortisone. Amongst the 3 patients of the switch group, C-reactive protein was slightly increased in one patient with CD, but all the 3 patients maintained the remission at week 24.

Conclusion

IFXBS is considered to be efficacious and safe compared with Remicade®.