Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study

Abstract

Objective: To assess the efficacy, tolerability, and safety of CT-P13 (Remsima^®) in patients with Crohn’s disease (CD) or ulcerative colitis (UC). Methods: This was a prospective observational study performed in a single center in Norway. Patients with CD (n = 46) or UC (n = 32) received CT-P13 (5 mg/kg) by intravenous infusion at weeks 0, 2, and 6. Efficacy end points included remission at week 14, measured by a Harvey-Bradshaw Index score of ≤4 or partial Mayo score of ≤2. Levels of the inflammatory markers C-reactive protein and calprotectin were measured. Adverse events up to week 14 were also recorded. Results: Seventy-nine percent of CD and 56% of UC patients achieved remission at week 14. Significant reductions in C-reactive protein and calprotectin occurred between baseline and week 14. There were no unexpected adverse events reported during the study. Conclusion: CT-P13 is efficacious and well tolerated in patients with CD or UC.

Keywords:

• biosimilar
• Crohn’s disease
• CT-P13
• efficacy
• inflammatory bowel disease
• infliximab
• Norway
• safety
• ulcerative colitis

Acknowledgement

The authors would like to thank the Department of Medical Biochemistry at Oslo University Hospital, Radiumhospitalet, for analysis of infliximab/CT-P13 trough levels and anti-drug antibodies.

Financial & competing interests disclosure

The authors have no 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. Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing and referencing) was provided by Rick Flemming (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

Key issues

• The TNF antagonist infliximab has improved outcomes in patients with inflammatory bowel disease; however, the high cost of biologic drugs in comparison to traditional therapy options may restrict access to treatment for some patients.

• A biosimilar to infliximab, CT-P13 has been approved by the EMA for indications including Crohn’s disease and ulcerative colitis, based on evidence of efficacy and safety in ankylosing spondylitis and rheumatoid arthritis and extrapolation of clinical data to other, non-rheumatic indications. However, little direct evidence exists regarding the efficacy and safety of CT-P13 in patients with inflammatory bowel disease.

• This prospective observational study was performed in a single center in Norway and demonstrated the efficacy and safety of CT-P13 in patients with Crohn’s disease or ulcerative colitis.

• Current evidence does not suggest a difference between infliximab reference medicinal product and CT-P13 in these indications.

Notes