Celltrion

• A post-hoc analysis of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) show that dose escalation of subcutaneous (SC) infliximab (CT-P13 SC) in patients who initially respond but subsequently lose response demonstrates clinical efficacy over 102 weeks, with safety profiles remaining comparable between those with and without dose escalation^1,2

• The findings highlight dose escalation in SC infliximab as a potential option for managing loss of response in inflammatory bowel disease (IBD), providing healthcare professionals with a more personalised approach to IBD care ¹

October 15, 2024 08:30 AM INCHEON, South Korea-Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna. The post-hoc analysis from the LIBERTY-CD (Crohn’s disease) and LIBERTY-UC (ulcerative colitis) studies suggest that dose escalation of CT-P13 SC following intravenous (IV) induction in patients who initially respond but subsequently lose response, showed clinical efficacy over an extended period of 102 weeks.

In the study, patients showed improvement in clinical remission at Week 102 [70.3% (26/37) in CD and 35.2% (25/71) in UC] or endoscopic response [40.5% (15/37) in CD] after dose escalation. Compared to the first dose escalation visit, patients who escalated the dose had a statistically significant reduction in mean modified Mayo score in UC (5.9 vs 2.1, P<0.0001) and mean CDAI score in CD (270.58 vs 76.31, P<0.0001) at Week 102.

The 2-year data from the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) suggest that dose escalation of subcutaneous infliximab is effective for patients who experience a loss of response after induction therapy, with comparable safety profiles. No new safety concerns were found after dose escalation in long term treatment. These findings indicate that dose escalation could be considered a potential option for managing loss of response in IBD.^1,2

“Dose escalation has long been an option for individual optimisation of IBD patients, particularly in those who lose response after induction therapy with IV infliximab,” said Professor Stefan Schreiber, University Hospital Schleswig-Holstein, Department of Internal Medicine I, Kiel, Germany. “The post-hoc analysis indicates that dose escalation of CT-P13 SC is a possibility to restore efficacy and optimize outcome in those who initially responded to induction. Dose escalation in SC infliximab has a comparable safety profile and makes a valuable contribution to long-term management strategies for patients with moderately to severely active IBD.”

“We are proud to share these important findings at UEGW, as they reinforce our commitment to advancing treatment options for patients with IBD,” said Mr. Kevin Byoung Seo Choi, Executive VP and head of the marketing division at Celltrion. “The updated SmPC in Crohn’s disease which notes that patients who initially responded to 5mg/kg but who lost response may regain response with dose escalation, along with the latest data, provide healthcare professionals with a personalised approach to IBD care, by addressing the complexities of managing this challenging condition.”³

About the subcutaneous (SC) formulation of CT-P13

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of 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 enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.^4,5

About Celltrion

Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima^®, Truxima^® and Herzuma^®, providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma^® and Yuflyma^®, FDA approval for Zymfentra^®, and EC approval for Remsima^® SC, Omlyclo^®, SteQeyma^®. To learn more, please visit www.celltrion.com/en-us.

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References

¹ S. Schreiber et al., Two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy as an option for managing loss of response in inflammatory bowel disease – from LIBERTY-UC and LIBERTY-CD study. Oral presentation. Presented at UEGW 2024.
² Hanauer SB et al., Subcutaneous Infliximab (CT-P13) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY) Gastroenterology. 2024. https://www.gastrojournal.org/article/S0016-5085(24)04918-7/fulltext#%20. [Last accessed October 2024]
³ European Medicines Agency. Subcutaneous and Intravenous Infliximab. Summary of product characteristics. 2024. https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf. [Last accessed October 2024]
⁴ Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.
⁵ Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.