Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn's disease and ulcerative colitis - experiences from a single center.

Abstract

BACKGROUND:

CT-P13 is the first biosimilar monoclonal antibody to infliximab (IFX); it has been approved for the same indications as its IFX counterpart in Hungary. The aim of this study was to assess the efficacy of CT-P13 induction therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC).

METHODS:

Patients diagnosed with CD and UC, who were administered CT-P13, were prospectively enrolled. Disease activity was estimated at the start and after the induction therapy. In patients with UC, sigmoideoscopy was also performed at the end of the induction therapy.

RESULTS:

Eighteen CD and 21 UC patients were enrolled. Induction treatment was completed in 16 of the CD and 15 of the UC patients. In those with luminal CD, clinical response and remission was achieved in 6 (37.5%) and 8 (50%) of the patients at Week 8. In UC, clinical response and remission was achieved in 3 (20%) and 10 (66.7%) patients at Week 8. Mucosal healing was shown in 11 patients.

CONCLUSIONS:

This was the first study to prospectively evaluate the outcome of CT-P13 induction therapy in CD and UC. Our results confirm that induction with CT-P13 is safe and effective.

• Authors: Klaudia Farkas, Mariann Rutka, Anita Bálint, Ferenc Nagy, Renáta Bor, Ágnes Milassin, Zoltán Szepes, Tamás Molnár
• Journal: Expert opinion on biological therapy (Expert Opin Biol Ther) Vol. 15 Issue 9 Pg. 1257-62 ( 2015) ISSN: 1744-7682 [Electronic] England
• PMID: 26134250 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Biosimilar Pharmaceuticals
• CT-P13
• Gastrointestinal Agents
• Infliximab

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (chemistry, metabolism, therapeutic use)
• Biosimilar Pharmaceuticals (therapeutic use)
• Colitis, Ulcerative (drug therapy, pathology)
• Colonoscopy
• Crohn Disease (drug therapy, pathology)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Infliximab (chemistry, metabolism)
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome
• Young Adult