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

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.

Conclusions: CT-P13 is efficacious and well tolerated in patients with CD or UC.