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Celltrion's New Insights on ZYMFENTRA® Efficacy in Crohn's Disease

On November 26, 2025, Celltrion, Inc. announced a significant post-hoc analysis of the LIBERTY-CD study, which illustrates the efficacy of their treatment ZYMFENTRA® (infliximab-dyyb) remains consistent regardless of the disease location in Crohn's disease (CD). Published in the journal Clinical Gastroenterology and Hepatology, these findings highlight the potential of ZYMFENTRA in addressing the varying needs of patients suffering from this challenging condition.

With Crohn's disease affecting a considerable number of individuals globally, the new analysis specifically points to the fact that ZYMFENTRA is effective across both ileum-dominant and colon-dominant forms of the disease. This consistency is crucial, especially because conditions associated with the terminal ileum often lead to poor long-term health outcomes.

As emphasized by Prof. Jean-Frédéric Colombel, MD of the Janowitz Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai, the outcomes substantiate ZYMFENTRA's applicability as an effective treatment option across various anatomical segments afflicted by Crohn's disease. According to the study, they analyzed endoscopic data from 329 patients, revealing that those treated with the subcutaneous formulation of infliximab—ZYMFENTRA—showed superior efficacy when compared to placebo across all evaluated endpoints.

The results from the study revealed striking differences in patient outcomes at Week 54. For those with ileum-dominant CD, the clinical remission rate was 60.95%, while the colon-dominant group reported a slightly higher rate of 66.95%. In stark contrast, only 37.25% and 29.09% of the placebo groups achieved similar results, respectively. Response rates reflected this trend, with clinical response rates recorded at 62.86% versus 41.18% in ileum-dominant patients, and 67.80% versus 38.18% in those with colon dominance. Remarkably, endoscopic response rates also mirrored these outcomes, reinforcing the treatment's effectiveness up to the terminal ileum.

Nam Lee, Vice President of Global Medical Affairs at Celltrion, expressed optimism about these findings. He indicated that with 70-80% of Crohn’s disease patients having ileal involvement at the time of diagnosis, the implications of an effective treatment for the ileum could benefit a vast number of patients requiring attention in this area. The full analysis entitled “Endoscopic response to subcutaneous infliximab by disease location” can now be accessed online in Clinical Gastroenterology and Hepatology.

What is ZYMFENTRA®?

ZYMFENTRA (infliximab-dyyb) is a subcutaneous treatment indicated for maintenance therapy in adults with moderately to severely active ulcerative colitis or Crohn's disease following intravenous infliximab treatment. This medication works by blocking tumor necrosis factor-alpha (TNF-alpha), a protein that can excessively act in certain diseases, enabling the immune system to harm healthy parts of the body.

Safety Considerations

While ZYMFENTRA presents significant therapeutic possibilities, potential risks associated with the medication cannot be overlooked. Patients treated with ZYMFENTRA carry an increased risk of serious infections, necessitating vigilance for signs of infections such as tuberculosis and certain fungal infections.

Furthermore, the use of ZYMFENTRA has been correlated with complications such as malignancies, including lymphomas and rare types of cancers, particularly in young adults, thereby emphasizing the importance of risk assessment prior to treatment initiation.

In conclusion, the post-hoc analysis of the LIBERTY-CD study presents promising evidence that ZYMFENTRA is effective for patients with Crohn’s disease regardless of disease location. With ongoing research and clinical trials, Celltrion continues to explore the full potential of its innovative products to enhance patient care and address the unmet needs in this therapeutic domain.