CT-P13 comparable to infliximab at 54 weeks for ankylosing spondylitis .
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Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study
Arthritis Res Ther. 2016 Jan 20;18(1):25250 ankylosing spondylitis patients were randomized to receive 5mg/kg of either CT-P13 or Infliximab through intravenous infusion for 54 weeks. The purpose of this study was to compare CT-P13, a biosimilar drug, to a known efficacious treatment of this pathology to determine its efficacy, immunogenicity, pharmacokinetics, and safety. The findings displayed similar results between groups for all patient reported efficacy outcomes, adverse events, and pharmacokinetic parameters, as well as in the proportion of patients testing positive for anti-drug antibodies at 54 weeks.
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