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

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

“As immunogenicity is the most significant concern when restarting treatment with infliximab after an interruption, these results suggest that treatment persistence was 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's reassuring to see that not only can we effectively recapture disease control with a convenient subcutaneous option, but that this response was seen early and was shown to be maintained through Week 102 in a post-hoc analysis from the pivotal LIBERTY studies. This is a significant finding for patients, as it offers a potentially reliable strategy for providers and transformative opportunity for patients to manage their IBD journey even when treatment is interrupted.”

“In clinical practice, patients may experience treatment interruption for clinical and non-clinical reasons, and initiation of treatment demands careful consideration of the risks,” said Professor Stefan Schreiber, University Hospital Schleswig-Holstein, Department of Medicine I, Kiel, Germany. “This data provides evidence that subcutaneous infliximab can effectively and safely recapture disease control, offering a viable treatment option for both clinicians and patients.”

The analysis evaluated the efficacy and safety of starting SC infliximab 240mg in patients, randomised to the placebo maintenance arm in the Phase 3 LIBERTY studies, who had previously completed intravenous (IV) infliximab induction and subsequently experienced a drug holiday of 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 early by 8±2 weeks and was maintained through the study. At the end of the treatment, 61.1% in CD and 65.2% in UC patients achieved faecal calprotectin remission, and 64.0% in CD and 68.8% in UC patients achieved endoscopic response/ improvement. Persistence in treatment end was 72.3% of CD patients and 61.9% of UC patients. Serum infliximab levels increased after initiating SC infliximab and remained stable through Week 102, with no new safety concerns observed.

The results demonstrated that initiation of treatment with SC infliximab 240 mg was effective to recapture and maintain disease control for Crohn’s disease (CD) and ulcerative colitis (UC) patients, suggesting SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruption.

Additionally, Celltrion will host a satellite symposium titled, “Enhancing Patient Management with Subcutaneous Infliximab: Practical Insights & Discussion.” on Friday, February 20 from 12:45 to 13:25, 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 studies reinforces the growing body of evidence supporting subcutaneous infliximab as a critical treatment option for the gastroenterology community,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “The data presented at ECCO 2026 further demonstrate our leadership and long-standing commitment to raising standards of care in gastroenterology and to improving the lives of people with Inflammatory Bowel Disease.”

Notes to Editors:

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.^2,3 In July 2024, CT-P13 SC received final approval from the European Commission for an additional dosing regimen and dose escalation, which allows 3-intraveneous (IV) induction dosing regimen and dose escalation of subcutaneous maintenance dose from CT-P13 SC 120 mg Q2W to 240 mg Q2W for patients with loss of response.⁴ Long term data from two-year extension of the LIBERTY studies (LIBERTY-CD and LIBERTY-UC) have demonstrated sustained 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 that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, haematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook.

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References

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1 Colombel JF et al., Recapturing disease control with subcutaneous infliximab after a drug holiday following intravenous infliximab induction: A post hoc analysis of LIBERTY-CD and -UC studies. Poster Presentation (P0832) at ECCO 2026.

2 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.

3 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

4 European Medicines Agency. Remsima - Summary of Product Characteristics (SmPC). [Accessed January 2026]

5 Colombel JF et al., Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn’s Disease and Ulcerative Colitis: 2-Year Results from Open Label Extensions of Two Randomized Controlled Trials (LIBERTY). Journal of Crohn’s and Colitis. 2025;19(6):jjaf060.

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