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

Abstract

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 centers. Method(s):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 naive or switch groups defined by a history of treatment with anti-TNF agents prior to receiving CT-P13. In the naive 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, 20041 and Hanauer SB, 20022 in FCD and CD, respectively. The safety profiles were assessed throughout the study. Result(s): A total of 204 patients consisting of 24 FCD patients and 180 CD patients were enrolled in the study. In the naive 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 naive 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(s): Remission rates treated with CT-P13 showed clinically consistent results to historical data3,4,5,6. 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. (Figure Presented).