Subcutaneous Infliximab Recaptures Disease Control After Treatment Interruption
New data from LIBERTY studies show subcutaneous infliximab effectively restored and maintained disease control in Crohn's disease and ulcerative colitis patients after drug holiday of 16 weeks or more, with sustained efficacy through Week 102.
Celltrion, Inc. 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. The data will be presented as a poster presentation at the 21st Congress of the European Crohn's and Colitis Organisation (ECCO), to be held from February 18-21 in Stockholm, Sweden.
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.
A professor of pediatrics and director of the IBD Center at the Icahn School of Medicine at Mount Sinai stated that 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. The professor noted it's reassuring to see that not only can disease control be effectively recaptured 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.
A professor at University Hospital Schleswig-Holstein, Department of Medicine I, Kiel, Germany, stated that in clinical practice, patients may experience treatment interruption for clinical and non-clinical reasons, and initiation of treatment demands careful consideration of the risks. This data provides evidence that subcutaneous infliximab can effectively and safely recapture disease control, offering a viable treatment option for both clinicians and patients.
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 Vice President of Global Medical Affairs at Celltrion stated that the comprehensive data from the studies reinforces the growing body of evidence supporting subcutaneous infliximab as a critical treatment option for the gastroenterology community. The data presented at ECCO 2026 further demonstrate the company's leadership and long-standing commitment to raising standards of care in gastroenterology and to improving the lives of people with Inflammatory Bowel Disease.
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. 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.