Celltrion Confirms Consistent Therapeutic Effects of Zympentra in Small Bowel-Type Crohn's Disease

Overcoming the Limitations of Existing Treatments

Celltrion announced on November 26 that the results of a global phase 3 post-hoc analysis of Zympentra, the subcutaneous (SC) formulation of Remsima (ingredient: infliximab) for autoimmune diseases, have been published in a prestigious international academic journal.

Zympentra. Celltrion

The published study is a post-hoc analysis of the 'LIBERTY-CD' clinical trial conducted on patients with Crohn's disease, and it appeared in the SCI journal 'Clinical Gastroenterology and Hepatology.' This journal ranks in the top 6% of its field based on impact factor.

The LIBERTY-CD trial was conducted to confirm the superiority of infliximab SC maintenance therapy over placebo in patients with moderately to severely active Crohn's disease. The published paper provides a detailed analysis of treatment responses by region (such as the small intestine and colon) and by segment (including the terminal ileum, left colon, transverse colon, right colon, and rectum), as confirmed through colonoscopy.

Crohn's disease, a chronic inflammatory bowel disease, is classified according to the location of inflammation, such as small bowel type or colonic type. Among these, the small bowel type is relatively more difficult to diagnose compared to the colonic type and is more prone to complications such as perforation and stricture, resulting in differences in symptoms and disease progression. The academic community also points out that responses to drug therapy may vary depending on the affected region.

In this post-hoc analysis, it was confirmed that the group of patients who received infliximab SC maintenance therapy for one year showed significant therapeutic effects compared to placebo, regardless of the site of inflammation. Consistent treatment effects were observed across all inflammatory sites, from the small intestine and terminal ileum to the colon and rectum. This result differentiates Zympentra from existing Crohn's disease treatments, which often show varying efficacy depending on the location. The findings are expected to serve as important evidence for future treatment strategies and therapeutic choices involving infliximab SC.

Additionally, infliximab SC was shown to be unaffected by patient factors or treatment strategies in both small bowel and colonic types, providing evidence that it can deliver stable efficacy across various treatment approaches.

A Celltrion representative stated, "This post-hoc analysis demonstrates that Zympentra delivers consistent therapeutic effects regardless of the site of inflammation, suggesting the potential to overcome the limitations of existing treatments. Based on its proven convenience of administration and excellent efficacy, we will do our utmost to improve the quality of life for more patients and rapidly expand its prescription."

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