Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

ABSTRACT

Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn’s disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period.

Patients and methods: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled. Clinical response was assessed at week 14 and week 54. Predictive factors for disease outcome at week 54 were evaluated.

Results: 57 CD and 57 UC patients were included; 55 CD and 49 UC patients completed the induction therapy and 50 CD and 46 UC patients completed the 54-week treatment period. Clinical remission was achieved in 65.5% of CD and 75.5% of UC patients at week 14. Rate of continuous clinical response was 51% in both CD and UC at week 54. None of the examined parameters were predictive to the clinical outcome neither in CD, nor in UC.

Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD. Response rates at week 54 were similar in CD and UC.

KEYWORDS:

• Crohn’s disease
• ulcerative colitis
• CT-P13
• biosimilar
• long-term efficacy
• predictors

Declaration of interest

PL Lakatos has been a speaker and/or advisory board member for AbbVie, Egis Pharmaceuticals PLC, Falk Pharma GmbH, Ferring Pharmaceutical Ltd, Genentech, Hospira, Kyowa Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, Merck Sharp and Dohme, Otsuka Pharma, Pharmacosmos, Pfizer Inc, Roche and Takeda and has received unrestricted research grants from AbbVie, Merck Sharp and Dohme and Hospira/Pfizer Inc. 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 apart from those disclosed.

Additional information

Funding

The authors are supported by the National Research, Development and Innovation Office (grant no. 119809), the Hungarian Scientific Research Fund (grant no. 115345), the János Bolyai Research Scholarship of the Hungarian Academy of Sciences (award no. BO/00632/14/5) and the New National Excellence Program of the Ministry of Human Capacities (award no. ÚNKP-ÚNKP-16-4).