Celltrion has announced two-year findings from a post-hoc analysis of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC), presented at United European Gastroenterology (UEG) Week 2024 in Vienna. The analysis shows that dose escalation of subcutaneous infliximab (CT-P13 SC) is effective for patients with inflammatory bowel disease (IBD) who initially responded to treatment but later lost response. The results indicate sustained clinical efficacy over 102 weeks, with safety profiles comparable between patients who underwent dose escalation and those who did not.
The study included patients with Crohn’s disease and ulcerative colitis who had received an intravenous induction of CT-P13 SC. After dose escalation, 70.3% of Crohn’s disease patients and 35.2% of ulcerative colitis patients achieved clinical remission at week 102. Additionally, 40.5% of Crohn’s disease patients showed an endoscopic response. Significant reductions in disease severity scores were also observed, with the mean modified Mayo score for ulcerative colitis decreasing from 5.9 to 2.1 and the mean CDAI score for Crohn’s disease dropping from 270.58 to 76.31.
The data suggest that dose escalation could be a viable strategy for managing loss of response in IBD, offering a personalized approach to care. No new safety concerns emerged during long-term treatment with the escalated dose.
“Dose escalation has long been a strategy for optimizing outcomes in IBD patients who lose response after induction therapy,” said Prof. Stefan Schreiber of the University Hospital Schleswig-Holstein, Germany. “This analysis supports the use of CT-P13 SC dose escalation to restore efficacy and improve long-term management for moderately to severely active IBD.”
Kevin Byoung Seo Choi, Executive Vice President at Celltrion, emphasized that these findings align with the updated Crohn’s disease SmPC, which recommends dose escalation for patients who lose response. He noted, “The latest data provide healthcare professionals with a personalized approach to addressing the complexities of IBD management.”
These findings reinforce the role of CT-P13 SC dose escalation as an important option for IBD treatment, aiming to improve patient outcomes over the long term.
About the subcutaneous (SC) formulation of CT-P13
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A fixed dose of 120 mg CT-P13 SC has been approved for use in 60 countries, including the US, UK, EU, Canada, Brazil, Australia, and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to improve treatment options by providing high consistency in drug exposure and a convenient route of administration. 4,5
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea. It is engaged in the research, development, manufacturing, marketing and sales of innovative therapeutic products that improve the lives of people around the world. Its portfolio includes world-class monoclonal antibody biosimilars such as Remsima ® , Truxima ® and Herzuma ® , ensuring broader access for patients worldwide. Celltrion has also received US FDA and CE approval for Vegzelma ® and Yuflyma ® , FDA approval for Zymfentra ® , and CE approval for Remsima ® SC, Omlyclo ® , SteQeyma ® .
