INCHEON, SOUTH KOREA --  Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Celltrion also presented endoscopic outcomes from the post-hoc analysis of the LIBERTY-CD study.3

These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.

Two-year results of CT-P13 SC LIBERTY studies

The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials. The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.

In the CT-P13 SC LIBERTY-CD study, a total of 180 patients with moderately to severely active CD entered into the extension phase up to Week 102 and received CT-P13 SC 120mg regardless of the previous assigned arm of maintenance phase. 154 (85.6%) patients completed the extension phase, and efficacy results, including clinical remission, clinical response, endoscopic remission, endoscopic response, and corticosteroid-free remission, were generally maintained at Week 102 compared to Week 54. No new safety issues were reported during the extension phase.

In the CT-P13 SC LIBERTY-UC study, a total of 237 patients with moderately to severely active UC entered into the extension phase and received CT-P13 SC regardless of the previous treatment group randomized at the start of maintenance phase. The LIBERTY-UC study demonstrated sustained efficacy through Week 102, with 208 (87%) patients completing the extension phase. Clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at Week 102 compared to Week 54. No new safety concerns were observed during the extension phase.

“These data reinforce the efficacy and safety profile of subcutaneous infliximab (CT-P13 SC), and demonstrate it can be used as a long-term treatment option for patients living with moderately and severely active CD and UC patients,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the poster presentation. “The combination of convenience with robust clinical data has the potential to offer benefits for patients navigating the challenges of managing IBD.”

Post-hoc analysis of CT-P13 SC LIBERTY-CD study

A separate post hoc analysis investigated the pattern of endoscopic mucosal healing across intestinal segments in patients with CD receiving CT-P13 SC maintenance treatment in the Phase 3 LIBERTY-CD study.

The endoscopy study led to high and consistent endoscopic mucosal healing rates across all segments up to one year, including the terminal ileum, with CT-P13 SC maintenance therapy. The rates of endoscopic complete mucosal healing and partial mucosal healing were significantly higher in the CT-P13 SC arm compared to placebo.

“The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion. “These study results capture our ongoing commitment to the IBD community and underscore our mission to improve patients’ lives by targeting diseases with high unmet needs.”

A total of 32 abstracts regarding CT-P13 SC were presented at the ECCO congress.