Celltrion Unveils New Post-Hoc Analyses of LIBERTY Studies at the 20 th ECCO Congress Further Evaluating the Efficacy and Safety of Subcutaneous (SC) Infliximab

Celltrion announced new post-hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), at the 20^th European Crohn’s and Colitis Organisation (ECCO) Congress showcasing the treatment’s effectiveness across a range of key clinical outcomes in inflammatory bowel disease (IBD). The analyses highlight Celltrion’s ongoing efforts to evaluate the efficacy and safety of subcutaneous (SC) infliximab (CT-P13 SC) in achieving endoscopic-histologic remission in ulcerative colitis (UC), clinical and endoscopic improvement across all disease locations in Crohn’s disease (CD), and supporting early clinical recapture after dose escalation following loss of response in CD and UC, and long-term drug persistence regardless of ADA in CD patients.^3,4,5,6

LIBERTY-UC Phase III Post-Hoc Analysis (LIBERTY-UC Endo-Histological Outcome)

A post-hoc analysis of the Phase 3 LIBERTY-UC study showed that maintenance therapy with SC infliximab resulted in significantly greater improvements in endoscopic and histologic outcomes at Week 54 compared to placebo. Endoscopic improvements were observed as early as Week 8, along with enhancements in stringent endpoints such as endoscopic normalisation and the combined endpoint of histologic remission and endoscopic normalisation over time, supporting the sustained benefit of a maintenance therapy with SC infliximab.

Endoscopic improvements were observed in half of the patients in both groups at week 8. However, from Week 22 onwards, the difference in rates of endoscopic improvement between the two groups was statistically significant, with SC infliximab showing higher rates (50.7% vs 34.0%; p=0.0011) up to Week 54 (43.9% vs 22.2%; p<0.0001). Similar findings were observed for histologic remission. Endoscopic normalisation rate in the SC infliximab group increased with continued treatment while it declined in the placebo group (23.8% vs 21.5% at Week 8; 26.9% vs 18.8% at Week 22; 32.7% vs 11.1% at Week 54). Furthermore, a greater proportion of patients in the SC infliximab group achieved combined histologic remission and endoscopic normalisation compared to the placebo group from Week 22 up to Week 54 (22.1% vs 16.7% at W22; p=0.2072; 27.9% vs 11.1% at W54; 51 p<0.0001).³

LIBERTY-CD Phase III Post-Hoc Analysis (LIBERTY-CD Disease Location)

A post-hoc analysis of the Phase 3 LIBERTY-CD study examined the efficacy of SC infliximab in patients according to disease locations (ileal, ileocolonic or colonic).

The finding shows SC infliximab maintenance therapy was effective across all disease locations with statistically significant higher rate of endoscopic response at Week 54 compared to placebo. At Week 54, patients receiving SC infliximab maintenance therapy achieved a significantly higher numerical and/ or statistical clinical remission rate compared to placebo across all disease locations (ileal: 45.5% vs 16.7%, P=0.065; ileocolonic: 68.1% vs 48.5%, P=0.083; colonic: 67.0% vs 29.1%, P<0.001). A greater proportion of patients who received SC infliximab achieved endoscopic response than those who received placebo across all disease locations (ileal: 36.4% vs 5.6%, P=0.019; ileocolonic: 61.1% vs 27.3%, P=0.006; colonic: 52.5% vs 18.2%, P<0.001). Patients who achieved both clinical remission and endoscopic response at Week 54 showed similar proportional differences between SC infliximab and placebo, irrespective of disease location (ileal: Δ30.3%, P=0.009; ileocolonic: Δ32.7%, P=0.003; colonic: Δ35.7%, P<0.001).⁴

Additional Post-Hoc Analyses

A separate post-hoc analysis on dose escalation in both UC and CD patients (LIBERTY-CD & UC Dose Escalation) found that dose escalation with SC infliximab after loss of response (LoR) resulted in rapid clinical recapture in both CD and UC patients, with significantly elevated serum infliximab levels in early recapturers.⁵

Finally, a post-hoc analysis from LIBERTY-CD study (LIBERTY-CD 2Y Immunogenicity) examined the role of anti-drug antibodies (ADA) in patients treated with SC infliximab. The analysis shows that despite the occurrences of ADAs, there was no significant impact on drug persistence and clinical efficacy up to and including Week 102.⁶

“The combined achievement of both endoscopic and histologic remission is an emerging therapeutic target in ulcerative colitis (UC), and it has been associated with lower clinical relapse rates and reduced corticosteroid use,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the digital oral presentation. “It is encouraging to see more treatment options such as subcutaneous infliximab, that can help achieve these important goals. This is a positive step forward, as these outcomes contribute not only to better disease control but also to improved long-term prognosis and quality of life for patients.”

“We are pleased to present important data points, including the impact of SC infliximab on achieving endoscopic and histologic remission in UC, as well as insights into dose escalation after loss of response in IBD,” said Nam Lee, Vice President of Global Medical Affairs at Celltrion. “These findings provide valuable evidence to support physicians in clinical practice and reinforce our commitment to enhancing treatment options and improving patient outcomes.”

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.^7,8

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

¹ Jean F. Colombel et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: 2 years results of the LIBERTY-CD study. Poster (Su1762). Presented at DDW 2024. Available at: https://www.gastrojournal.org/article/S0016-5085(24)02326-6/abstract [Last accessed February 2025]
² Bruce E. Sands et al., Subcutaneous infliximab (CT-P13 SC) for ulcerative colitis: 2-year extension results of the LIBERTY-UC study. Poster (Su1779). Presented at DDW 2024. Available at: https://www.gastrojournal.org/article/S0016-5085(24)02343-6/pdf [Last accessed February 2025]
³ Jean F. Colombel et al., Endoscopic and histologic outcomes in patients with moderate-to-severe ulcerative colitis treated with infliximab: A post hoc analysis of the Phase 3 LIBERTY-UC study. Digital Oral Presentation (DOP 001). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i77/7967018 [Last accessed February 2025]
⁴ Stefan Schreiber et al., Efficacy of subcutaneous infliximab maintenance therapy according to disease location in patients with moderate-to-severe Crohn’s disease: A post hoc analysis of the Phase 3 LIBERTY-CD study. Poster (P0702). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i1374/7967805 [Last accessed February 2025]
⁵ Marla C. Dubinsky et al., Time to clinical recapture after dose escalation of subcutaneous Infliximab (CT-P13 SC) following loss of response: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials. Poster (P1142). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i2091/7971751 [Last accessed February 2025]
⁶ Bruce E. Sands et al., Impact of immunogenicity on 2-year clinical outcomes in patients with moderate-to-severe Crohn’s disease treated with subcutaneous infliximab: A post hoc analysis of the Phase 3 LIBERTY-CD study. Poster (P0638). Presented at ECCO 2025. Available at: https://academic.oup.com/ecco-jcc/article/19/Supplement_1/i1255/7967790 [Last accessed February 2025]
⁷ Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.
⁸ Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.

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