Celltrion Publishes New Study Supporting ZYMFENTRA® Efficacy

Celltrion, Inc. has announced the publication of a post-hoc analysis from the LIBERTY-CD study, affirming the consistent efficacy of ZYMFENTRA® (infliximab-dyyb) across various disease locations in patients with Crohn’s disease. The findings were published in the peer-reviewed journal, Clinical Gastroenterology and Hepatology, on November 26, 2025.

The study analyzed endoscopic data from the phase 3 LIBERTY-CD trial, which focused on patients with moderately-to-severely active Crohn’s disease receiving maintenance treatment with subcutaneous infliximab. The analysis included 329 patients, revealing that 52.6% had colon-dominant Crohn’s disease, while 47.4% were diagnosed with ileum-dominant Crohn’s disease.

According to Prof. Jean-Frédéric Colombel, MD at the Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, the results are significant. “The consistency of treatment effect across disease locations is important, as ileal Crohn’s disease is highly correlated with negative long-term outcomes, and the terminal ileum is the most challenging segment to treat,” he stated.

The study reported that at Week 54, patients treated with ZYMFENTRA® achieved greater efficacy outcomes across all endpoints compared to those receiving a placebo, regardless of disease location. Specifically, the rates of clinical remission were 60.95% in the ileum-dominant group and 66.95% in the colon-dominant group, compared to 37.25% and 29.09%, respectively, in the placebo cohort.

Clinical responses also demonstrated a similar trend, with rates of 62.86% versus 41.18% in the ileum-dominant group and 67.80% versus 38.18% in the colon-dominant group. Moreover, endoscopic response rates further indicated that ZYMFENTRA® outperformed placebo across all ileocolonic segments, including the terminal ileum.

Nam Lee, Vice President of Global Medical Affairs at Celltrion, emphasized the importance of effective treatments for ileal involvement in Crohn’s disease. “As 70-80% of patients with Crohn’s disease have ileal involvement at diagnosis, effective treatment of the ileum has the potential to benefit a large proportion of patients with Crohn’s disease,” he noted.

The comprehensive manuscript titled “Endoscopic response to subcutaneous infliximab by disease location: A post hoc analysis of the LIBERTY-CD study” is now available for review in Clinical Gastroenterology and Hepatology.

ZYMFENTRA® is a prescription medication administered via subcutaneous injection for the maintenance treatment of moderately-to-severely active ulcerative colitis and Crohn’s disease, following treatment with an intravenous infliximab product. It works by blocking the action of tumor necrosis factor-alpha (TNF-alpha), a protein linked to inflammatory responses in various diseases.

As a biologic treatment, ZYMFENTRA® has received approval from the FDA and is expected to maintain patent protection for its dosage form until 2037 and its route of administration until 2040.

In clinical trials, patients treated with ZYMFENTRA® have shown notable improvements, but it is important to note potential risks. Serious infections, malignancies, and hepatotoxicity have been observed in patients receiving TNF blockers, including infliximab products. Patients should be monitored closely for these effects.

Celltrion, Inc. is a leading biopharmaceutical company based in Incheon, South Korea, specializing in the development of innovative therapeutics. The company is recognized for its pioneering efforts in the biosimilar market, aiming to enhance patient care globally.

For further information about ZYMFENTRA® and Celltrion’s full range of products, visit their official website.