New ECCO data shows subcutaneous (SC) infliximab (Remsima™ SC) effectively recaptures and maintains disease control after drug discontinuation

Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY study (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in the majority of Crohn’s disease (CD) and ulcerative colitis (UC) patients with sustained efficacy, safety and persistence through Week 102.¹ This data will be presented in the form of a poster presentation on the 21st^st Congress of the European Crohn’s and Colitis Organization (ECCO), which will be held February 18-21 in Stockholm, Sweden.

“Because immunogenicity is the most significant concern when restarting treatment with infliximab after discontinuation, these results suggest that treatment persistence is maintained even in patients with immunogenicity,” said Dr. Marla Dubinsky, Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “It is reassuring to see that not only can we effectively regain disease control with an easy-to-use subcutaneous option, but this response was seen early and was shown to persist through Week 102 in a post-hoc analysis of the landmark LIBERTY study. This is a significant finding for patients, as it offers a potentially reliable strategy for providers and a transformative opportunity for patients to manage their IBD course even when treatment is discontinued.”

“In clinical practice, patients may experience treatment discontinuation for clinical and non-clinical reasons, and starting treatment requires careful risk consideration,” said Professor Stefan Schreiber, Schleswig-Holstein University Hospital, Department of Medicine I, Kiel, Germany. “These data provide evidence that subcutaneous infliximab can effectively and safely control disease recurrence, offering a viable treatment option for physicians and patients.”

This analysis evaluates the efficacy and safety of administering SC infliximab 240mg in patients, randomized to the placebo maintenance arm in the Phase 3 LIBERTY study, who had previously completed intravenous (IV) infliximab and then been off medication for 16 weeks or more before starting SC infliximab due to disease progression.

Among 51 CD and 77 UC patients who initiated treatment with SC infliximab, clinical response was observed as early as 8±2 weeks and maintained throughout the study. At the end of treatment, 61.1% of CD patients and 65.2% of UC patients achieved fecal calprotectin remission, and 64.0% of CD patients and 68.8% of UC patients achieved endoscopic response/improvement. Persistence at the end of treatment was 72.3% of CD patients and 61.9% of UC patients. Serum infliximab levels increased after starting SC infliximab and remained stable through Week 102, with no new safety concerns observed.

The results suggest that initiation of treatment with SC infliximab 240 mg is effective for regaining and maintaining disease control in patients with Crohn’s disease (CD) and ulcerative colitis (UC). This suggests that SC infliximab provides an effective and safe option to regain clinical control after planned or unplanned treatment discontinuation.

Additionally, Celltrion will host a satellite symposium entitled, “Improving Patient Management with Subcutaneous Infliximab: Insights & Practical Discussion.” on Friday, February 20 from 12:45 to 1:25 p.m., in Room A12 at Stockholmsmässan. Chaired by Professor Jean-Frédéric Colombel, the symposium will feature presentations from Professor Anthony Buisson and Professor Axel Dignass.

“The comprehensive data from the study reinforces the growing body of evidence supporting subcutaneous infliximab as an important treatment option for the gastroenterology community,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The data presented at ECCO 2026 further demonstrates our leadership and long-term commitment to raising standards of care in the field of gastroenterology and improving the lives of people with Inflammatory Bowel Disease.”

Notes to Editors:

About the subcutaneous (SC) CT-P13 formulation.

CT-P13 SC is the world’s first subcutaneous formulation of infliximab. CT-P13 SC fixed dose 120mg has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of weight. SC formulations of infliximab have the potential to improve treatment options by providing high consistency in drug exposure and a convenient method of administration.^2,3 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dose regimen and dose escalation, allowing a 3-intravenous (IV) induction dose regimen and a subcutaneous maintenance dose increase from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.⁴ Long-term data from two-year extensions of the LIBERTY study (LIBERTY-CD and LIBERTY-UC) have demonstrated the continued efficacy and safety of CT-P13 SC, with clinical remission, response, and corticosteroid-free remission generally maintained through Week 102.⁵

About Celltrion

Celltrion is a leading biopharmaceutical company specializing in the research, development, production, marketing and sale of innovative therapies that improve people’s lives around the world. Celltrion is a pioneer in the biosimilar space, having launched the world’s first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a wide range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. In addition to biosimilar products, we are committed to developing new medicinal products to push the boundaries of scientific innovation and produce quality medicines. For more information, please visit our website www.celltrion.com/en-us and keep up with the latest news and events on our social media – LinkedIn, Instagram, X and Facebook.

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Reference

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