Abstract: A novel subcutaneous formulation of the infliximab biosimilar CT-P13 might be a more convenient option for patients with Crohn's disease, if results presented by Stefan Schreiber (Kiel, Germany) and colleagues are confirmed in an ongoing formal efficacy trial. 44 patients with active Crohn's disease were treated with intravenous CT-P13 at weeks 0 and 2, and at week 6 were randomly assigned to one of four cohorts—one with continued dosing of intravenous CT-P13, or one of three different doses of subcutaneous CT-P13. All patients received treatment for 30 weeks. Efficacy measures—including change from baseline in the Crohn's disease activity index and clinical remission—were similar in those receiving subcutaneous CT-P13 compared to those with intravenous CT-P13, as were safety profiles. A lower proportion of patients were positive for anti-drug antibodies following treatment with subcutaneous CT-P13 than with the intravenous formulation. Pharmacokinetic and pharmacodynamic modelling suggested that subcutaneous and intravenous formulations were similar in patients with active Crohn's disease.
Publication Year: 2018
Publication Date: 2018-06-14
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 1
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