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Expert Rev Gastroenterol Hepatol · Jan 2015
Observational StudyBiosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study.
- Jørgen Jahnsen, Trond Espen Detlie, Simen Vatn, and Petr Ricanek.
- a 1 Akershus University Hospital, Lørenskog, Norway.
- Expert Rev Gastroenterol Hepatol. 2015 Jan 1; 9 Suppl 1: 45-52.
ObjectiveTo assess the efficacy, tolerability, and safety of CT-P13 (Remsima(®)) in patients with Crohn's disease (CD) or ulcerative colitis (UC).MethodsThis 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.ResultsSeventy-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.ConclusionCT-P13 is efficacious and well tolerated in patients with CD or UC.
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