Abstract
A subcutaneous formulation of the infliximab biosimilar CT-P13 is safe and suitable to use in the treatment of inflammatory bowel disease (IBD). Stefan Schreiber and colleagues randomly assigned patients with active ulcerative colitis or Crohn's disease to receive subcutaneous CT-P13 every 2 weeks (n=66) or intravenous CT-P13 every 8 weeks (n=65), following a dose-loading phase. The ratio of geometric least-squares means of CT-P13 trough concentrations at week 22 was 1154·2% (90% CI 786·4–1694·0), indicating non-inferiority of the subcutaneous formulation relative to the intravenous formulation. At week 30, response rates were not significantly different in the subcutaneous CT-P13 group compared with the intravenous CT-P13 group. Clinical remission rates were also not significantly different between groups.
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