Publications by authors named "DaBee Jeon"
Introduction: This study aimed to demonstrate the interchangeability of biosimilar CT-P17 and European Union reference adalimumab (EU-adalimumab) in a repeated-switch scenario.
Methods: In this ongoing, randomized, double-blind, active-controlled, phase 3 study, adults with moderate-to-severe plaque psoriasis received 80 mg EU-adalimumab on day 1, then 40 mg 1 week later and every other week until week 11. At week 13, patients were randomized (1:1, via an interactive web response system) to continue EU-adalimumab ("continuous" group) or undergo repeated switches between CT-P17 and EU-adalimumab ("switching" group).
Background: CT-P47 is a candidate tocilizumab biosimilar that is currently in clinical development. We assessed the usability of CT-P47 self-administration via auto-injector (AI) in patients with rheumatoid arthritis (RA).
Research Design And Methods: This was a 12-week, single-arm, open-label, multiple-dose, Phase 3 study.
Background: This study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults.
Research Design And Methods: In this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS.
Background: CT-P43 is a candidate ustekinumab biosimilar in clinical development.
Objectives: This paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis.
Methods: This double-blind, phase III trial randomised patients (1:1) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I.
Article Synopsis
- CT-P47 is a biosimilar tocilizumab candidate being studied for its pharmacokinetic (PK) equivalence to the EU-approved reference drug in healthy Asian adults.
- The study used a double-blind, multicenter, parallel-group design, with participants receiving either CT-P47 or EU-tocilizumab, and focused on measuring various PK endpoints like AUC and maximum serum concentration (C).
- Results showed that CT-P47 had equivalent PK measures compared to EU-tocilizumab, was well-tolerated, and exhibited similar immunogenicity and safety profiles.
Article Synopsis
- A phase I double-blind trial in Japan compared the pharmacokinetics and safety of CT-P17 with EU-approved adalimumab in healthy adults.
- Participants were randomized to receive either CT-P17 or EU-adalimumab, with the main goal of assessing pharmacokinetic equivalence through measurements of serum concentration.
- Results showed that CT-P17 and EU-adalimumab had equivalent pharmacokinetics, and were similar in terms of safety and immunogenicity among the 204 participants who received the study drug.