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P500 Effectiveness and safety in Crohn's disease patients who were treated with CT-P13

Choe Y.H.*1, Lee S.-H.2, Park D.I.3, Lee J.H.4, Kim H.J.5, Kim Y.-H.6, Choi C.H.7, Eun C.S.8, Lee S.J.9, Lee S.9

1Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Pediatrics, Seoul, South Korea 2Esoo Hospital, Digestive Endoscopic Center, Cheonan-si, South Korea 3Kangbuk Samsung Hospital, Department of Internal Medicine, Seoul, South Korea 4Seoul Song Do Colorectal Hospital, Department of Internal Medicine, Seoul, South Korea 5Kyung Hee University College of Medicine, Department of Internal Medicine, Seoul, South Korea 6Samsung Medical Center, Sungkyunkwan University School of Medicine, Department of Internal Medicine, Seoul, South Korea 7Chung-Ang University College of Medicine, Department of Internal Medicine, Seoul, South Korea 8Hanyang University Guri Hospital, Hanyang University College of Medicine, Department of Internal Medicine, Guri, South Korea 9CELLTRION, Inc., Incheon, South Korea

Background

CT-P13 is a biosimilar to innovator infliximab (INX) and has been approved by the European Medicines Agency in 2013 and Food and Drug Administration in 2016. Here we present results from observational study in South Korea, which has been conducted at 24 study centres.

Methods

This observational study has been conducted from 2012 July to 2016 July. In patients with fistulizing Crohn's disease (FCD) and moderate to severe active Crohn's disease (CD) for 6 months of each patient and results were reported as either of naïve or switch groups defined by a history of treatment with anti-TNF agents prior to receiving CT-P13. In the naïve group, remission rate was evaluated at Week 14 and 30. In switch group, the remission rate was assessed during post-baseline visits and post-baseline remission was counted if at least one post-baseline result met remission criteria. Remission was defined according to Sands BE, 2004 [1] and Hanauer SB, 2002 [2] in FCD and CD, respectively. The safety profiles were assessed throughout the study.

Results

A total of 204 patients consisting of 24 FCD patients and 180 CD patients were enrolled in the study. In the naïve group with FCD patients, remission rates were 40.0% (4/10) and 60.0% (6/10) at Week 14 and 30, respectively. In the case of CD patients in naïve group, remission rates were more than 72.0% both at Week 2 and 30. In the switch group, the proportion of patients who achieved clinical remission were 87.5% and 80.0% in FCD and CD patients, respectively during post-baseline visits.

Throughout 30 week safety follow-up, 3 (1.6%) patients were reported as infusion-related reaction in CD. Among FCD and CD patients, 1 (4.2%) and 11 (6.1%) patients have experienced at least one related treatment-emergent adverse event (TEAE). There were a few treatment-emergent serious adverse events (TESAE) cases reported in FCD and CD patients which were 6 (25.0%) and 11 (6.1%), respectively.

Conclusion

Remission rates treated with CT-P13 showed clinically consistent results to historical data [3–6]. The overall safety profile also revealed that CT-P13 is well-tolerated up to 6 months in each patient with FCD or CD under routine care.

References:

[1] Sands BE et al. (2004), Infliximab maintenance therapy for fistulizing crohn's disease, N Engl J Med, 876–85, 350

[2] Hanauer SB et al. (2002), Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial, Lancet, 1541–49, 359

[3] Rutgeerts P et al. (2004), Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease, Gastroenterology, 402–413, 126

[4] Colombel JF et al. (2010), Infliximab, azathioprine, or combination therapy for Crohn's disease, N Engl J Med, 1385–95, 362

[5] Geese KB et al. (2016), Efficay and safety of biosimilar infliximab after one-year: Results from a prospective nationwide cohort, United European Gastroenterology Journal, A59–60, 4(5S)

[6] Jørgensen KK (2016), Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: Results from the 52-week randomized nor-switch trial, United European Gastroenterology Journal, 2 (supplement1)