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.

Keywords:

• Crohn’s disease
• CT-P13
• efficacy
• infliximab biosimilar
• ulcerative colitis

Acknowledgments

Study design, data collection, supervision of patient selection and manuscript preparation: Tamas Molnar, Klaudia Farkas, Mariann Rutka; study design, data collection, and manuscript preparation: Tamas Molnar, Klaudia Farkas, Zoltán Szepes, Ferenc Nagy; data collection and manuscript preparation: Klaudia Farkas, Anita Bálint, Renáta Bor, Ágnes Milassin. All authors have approved the final draft submitted.

Declaration of interest

This paper was supported by the János Bolyai Research Scholarship of the Hungarian Academy of Sciences (BO/00632/14/5) and OTKA PD 105948 (PI: Dr Klaudia Farkas). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

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