Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: An international, randomised, double-blind, phase 3 non-inferiority study
The Lancet Apr 03, 2019
Ye BD, et al. - In this randomised, multicentre, double-blind, phase 3 non-inferiority study, researchers ascertained if CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy. Patients with active Crohn's disease who had not responded to, or were intolerant to, non-biological treatments were included. Patients were assigned randomly (1:1:1:1) to receive CT-P13, then CT-P13, then infliximab, then infliximab, or infliximab, then CT-P13, with week 30 switching. At weeks 0, 2, 6, and then every 8 weeks up to week 54, subjects received 5 mg/kg CT-P13 or infliximab. In patients with active Crohn's disease, this investigation showed non-inferiority of CT-P13 to infliximab. A new option for treating active Crohn's disease could be biosimilar CT-P13.
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