- Latest data from the global Phase III pivotal data for LIBERTY studies show maintenance therapy with subcutaneous (SC) infliximab provides a robust clinical benefit, with the added convenience of SC administration, for patients with moderately to severely active inflammatory bowel disease (IBD)1,2
- Celltrion has submitted the global Phase III pivotal data to support its submission package to the FDA to enable this innovative and convenient treatment to become available for U.S. patients
- Data from a post-hoc analysis of Phase I study suggested an association between high Ctrough level and lower immunogenicity in SC infliximab treatment3
CHICAGO, Ill. — Today, Celltrion Healthcare presented new data demonstrating the efficacy and safety of subcutaneous (SC) infliximab (CT-P13 SC) in patients with inflammatory bowel disease (IBD). The data were presented in a digital oral presentation and poster presentations at the 18th European Crohn’s and Colitis Organisation (ECCO) annual congress, in Copenhagen, Denmark.
CT-P13 SC LIBERTY Studies
LIBERTY-CD and LIBERTY-UC were randomized, placebo-controlled, double-blind, Phase III studies designed to evaluate the superiority of the subcutaneous CT-P13 (CT-P13 SC) in efficacy and safety during maintenance therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC), respectively.1,2
In the CT-P13 SC LIBERTY-CD study, a total of 343 patients were randomized in a 2:1 ratio at Week 10. At Week 54, the clinical remission rate was greater in the CT-P13 SC arm than the placebo arm (62.3% and 32.1% respectively, P<0.0001). In the CT-P13 SC LIBERTY-UC study, a total of 438 patients were randomized at Week 10. The rate of clinical remission at Week 54 was significantly greater in CT- P13 SC (43.2%) compared to the placebo (20.8%) (P<0.0001). The safety profile during the maintenance phase was comparable between CT-P13 SC and the placebo arms for both studies.
“These latest findings add to the growing body of evidence that supports the SC formulation of infliximab as a convenient and effective solution for treating IBD,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the digital oral presentation. “These results demonstrate that maintenance therapy with CT-P13 SC provides a robust clinical benefit, with the convenience of SC administration, for patients with moderately to severely active CD and UC.”
“The positive global Phase III LIBERTY studies have allowed us submit CT-P13 SC to the FDA as a stand-alone Biologics License Application under the 351 (a) pathway and the results have also reinforced our conviction in the value of CT-P13 SC,” said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. “We believe that CT-P13 SC, if approved in the U.S., has the potential to become the next-generation innovative therapeutic for IBD given its favorable clinical results and convenient subcutaneous route of administration.”
CT-P13 SC PHASE I POST-HOC ANALYSIS AND REAL-WORLD CASE STUDIES
A separate post-hoc analysis of the randomised Phase I CT-P13 SC study data showed Ctrough level predicted anti-drug antibody (ADA) and neutralizing antibody (NAb) positivity in CD and UC patients, with a Ctrough threshold of 4.695 μg/mL significantly associated with lower rates of ADA and NAb positivity.3
In addition, real-world case studies presented during a satellite symposium at the ECCO congress indicate that reintroduction of infliximab may be a viable treatment option for CD patients with previous anti-TNF treatment failure, by aiming to reach a higher pharmacokinetics level and lower anti-drug antibody levels. Interim results of a pilot study suggest that SC infliximab may be a viable treatment option for patients with refractory CD.4
“Whilst there have been numerous recent advancements in IBD treatment options, there remains a pressing demand to address unmet medical need, especially for refractory IBD patients,” said Professor Milan Lukas, ISCARE and Charles University, Czech Republic, and one of the leading presenters for the satellite symposium. “These exploratory results suggest that SC infliximab could provide healthcare providers with a powerful treatment tool for CD patients who have previously been considered difficult to treat.”
– ENDS –
Notes to Editors:
About subcutaneous (SC) formulation of CT-P13
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120 mg fixed dose of CT-P13 SC has been approved for use in the European Union (EU), in adults regardless of body weight, in both existing and newly added indications. The SC formulation has the potential to enhance treatment options for the use of the infliximab drug by providing high consistency in drug exposure and a convenient method of administration.5,6
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: https://www.celltrionhealthcare.com/en-us/
About inflammatory bowel disease
Inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic, disabling gastrointestinal disorders that can significantly impact patients’ lives.7 They affect an estimated 10 million people globally.8 IBDs account for substantial costs to the healthcare system and society – the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.9
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1 Jean F. Colombel et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: A Phase 3, randomised, placebo-controlled study (LIBERTY-CD). Digital Oral Presentation (DOP86). Presented at ECCO 2023.
2 Bruce E. Sands et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for ulcerative colitis: A Phase 3, randomized, placebo-controlled study: Results of the LIBERTY-UC study. Poster (P492). Presented at ECCO 2023.
3 Stefan Schreiber et al., Predictors of immunogenicity in patients with inflammatory bowel disease treated with infliximab: A post hoc analysis of the randomised Phase I CT-P13 SC study. Poster (P524). Presented at ECCO 2023.
4 Lukas M et al. Infliximab CT P13 SC in refractory Crohn’s disease patients preliminary results of a pilot project Poster (P030). Presented at Crohn’s and Colitis Congress 2023.
5 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease, Journal of Crohn’s and Colitis, Volume 13, Issue Supplement_1, March 2019, Pages S066–S067, https://doi.org/10.1093/ecco-jcc/jjy222.096 [Last accessed February 2023].
6 R.Westhovens et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019
7 Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed February 2023].
8 The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Retrieved from www.efcca.org/content/what-ibd [Last accessed February 2023].
9 The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis, 7(4), 322-337. Retrieved from: www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed February 2023].