Celltrion has announced the two-year results of dose escalation therapy with subcutaneous infliximab (CT-P13 SC) at the United European Gastroenterology (UEG) Week 2024 in Vienna. A post-hoc analysis of the LIBERTY-CD (Crohn’s disease) and LIBERTY-UC (ulcerative colitis) studies indicates that dose escalation following intravenous (IV) induction showed clinical efficacy over 102 weeks in patients who lost efficacy after an initial response.
In the study, patients showed improvement in clinical remission at week 102: 70.3% (26/37) for Crohn’s disease and 35.2% (25/71) for ulcerative colitis. Endoscopic response was observed in 40.5% (15/37) of Crohn’s disease patients after dose escalation. Compared to the first dose escalation visit, those who underwent escalation experienced a statistically significant reduction in mean modified Mayo score for ulcerative colitis (5.9 vs. 2.1, P<0.0001) and mean CDAI score for Crohn’s disease (270.58 vs. 76.31, P<0.0001) at week 102.
The two-year data from the LIBERTY trials suggest that dose escalation of subcutaneous infliximab is effective for patients who lose response after induction therapy, with no new safety concerns observed. This indicates that dose escalation could be a viable option for treating loss of response in inflammatory bowel disease (IBD).
“Dose escalation has been a key strategy for optimizing treatment in IBD patients, especially for those who no longer respond to IV infliximab,” said Professor Stefan Schreiber from University Hospital Schleswig-Holstein. “The post-hoc analysis shows that dose escalation of CT-P13 SC can restore efficacy and enhance outcomes for patients who initially responded to induction therapy.”
Kevin Byoung Seo Choi, Executive VP at Celltrion, added, “We are proud to share these findings at UEGW, reinforcing our commitment to improving treatment options for IBD patients. The updated SmPC for Crohn’s disease highlights that patients initially responding to 5 mg/kg can regain efficacy with dose escalation, offering a personalized approach to managing this complex disease.”
Information on the Subcutaneous Formulation of CT-P13
CT-P13 SC is the world’s first subcutaneous formulation of infliximab, approved at a fixed dose of 120 mg in 60 countries, including the US, UK, EU, Canada, Brazil, Australia, and Taiwan, for adults regardless of body weight. This SC formulation aims to enhance treatment options by ensuring consistent drug exposure and offering a convenient administration method.
About Celltrion
Celltrion, based in Incheon, South Korea, is a leading biopharmaceutical company dedicated to discovering, developing, manufacturing, and distributing innovative therapeutics. The company offers a range of monoclonal antibody biosimilars, including Remsima®, Truxima®, and Herzuma®, improving patient access to treatments globally. Celltrion has received FDA and EU approvals for several products, including Vegzelma® and Yuflyma®, and European Commission approval for Remsima® SC, Omlyclo®, and SteQeyma®.
