Publications by authors named "Yun Ju Bae"
Article Synopsis
- The study aimed to show that CT-P47 is as effective as the EU-approved tocilizumab (r-TCZ) in treating rheumatoid arthritis (RA) patients.
- Conducted as a double-blind, phase III trial, 471 patients were randomized to receive either CT-P47 or r-TCZ, with efficacy measured primarily through changes in Disease Activity Score at specified weeks.
- Results indicated that both treatments had similar efficacy, pharmacokinetics, safety, and immunogenicity profiles, confirming CT-P47's equivalence to r-TCZ even after patients switched from r-TCZ to CT-P47.
CT-P47 is a candidate biosimilar of tocilizumab. This 12-week, randomized, double-blind, parallel-design, phase 1 study aimed to demonstrate pharmacokinetic (PK) equivalence of CT-P47 and reference tocilizumab. Participants were healthy Japanese adults aged 18-55 years.
View Article and Find Full Text PDFBackground: 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: This study's objective was to demonstrate pharmacokinetic (PK) similarity and safety of denosumab biosimilar, CT‑P41, and United States-licensed reference denosumab (US-denosumab) in healthy male Asian adults, considering also pharmacodynamic (PD) outcomes.
Research Design And Methods: This double-blind, two-arm, parallel-group, Phase 1 study randomized (1:1) healthy males to a single (60-mg) subcutaneous dose of CT‑P41 or US-denosumab. Primary endpoints were area under the concentration - time curve (AUC) from time zero to infinity (AUC), AUC from time zero to the last quantifiable concentration (AUC), and maximum serum concentration (C).
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.
Background: We evaluated clinical effectiveness of regdanvimab (CT-P59), a severe acute respiratory syndrome coronavirus 2 neutralizing monoclonal antibody, in reducing disease progression and clinical recovery time in patients with mild-to-moderate coronavirus disease 2019 (COVID-19), primarily Alpha variant.
Methods: This was phase 3 of a phase 2/3 parallel-group, double-blind, randomized clinical trial. Outpatients with mild-to-moderate COVID-19 were randomized to single-dose regdanvimab 40 mg/kg (n = 656) or placebo (n = 659), alongside standard of care.
Article Synopsis
- A study compared the safety and effectiveness of adalimumab biosimilar CT-P17 to the reference adalimumab in patients with active rheumatoid arthritis (RA) over 52 weeks.
- Results showed that efficacy rates were similar across groups, with minimal joint damage and comparable drug levels regardless of whether participants switched to CT-P17 or remained on the reference drug.
- Both CT-P17 and the reference drug exhibited similar safety profiles, and switching between them did not significantly impact immunogenicity.
Article Synopsis
- - The study aimed to compare the pharmacokinetic equivalence and safety of an adalimumab biosimilar (CT-P17) delivered via an autoinjector (AI) and a prefilled syringe (PFS) in healthy volunteers.
- - A total of 193 participants were randomized to receive either CT-P17 AI or CT-P17 PFS, with results showing that the pharmacokinetic profiles (including key metrics like AUC and maximum serum concentration) were equivalent within the defined margins.
- - Both delivery methods were well tolerated, showing similar safety and immunogenicity profiles, indicating that CT-P17 AI and CT-P17 PFS can be considered equivalent for clinical use.
Article Synopsis
- The study aimed to compare the efficacy of a high-concentration adalimumab biosimilar (CT-P17) to the EU-approved version in patients with active rheumatoid arthritis (RA).
- It involved a randomized, double-blind phase III trial with 648 participants receiving either CT-P17 or EU-adalimumab for 24 weeks, measuring the 20% improvement response rate according to ACR criteria.
- Results showed that both treatments had an equivalent response rate of 82.7%, with comparable safety profiles, demonstrating that CT-P17 is as effective and safe as the original medication.
Article Synopsis
- The study tested the pharmacokinetic (PK) equivalence of the adalimumab biosimilar CT-P17 compared to both US-licensed and EU-approved adalimumab through a clinical trial with healthy participants.
- Participants were randomly assigned to receive either CT-P17, US-adalimumab, or EU-adalimumab, and the study measured key PK indicators like concentration-time curves and maximum serum concentration.
- Results showed that CT-P17 was pharmacokinetically equivalent to the other adalimumab versions, with similar safety and immunogenicity profiles, supporting its potential as a viable biosimilar option.
Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.
Rheumatology (Oxford)
December 2019
Objective: To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA.
Methods: Patients received 48 weeks' treatment with CT-P10 or United States- or European Union-sourced reference rituximab (US-RTX and EU-RTX, respectively). Patients entering the extension period (weeks 48-72) remained on CT-P10 (CT-P10/CT-P10; n = 122) or US-RTX (US-RTX/US-RTX; n = 64), or switched to CT-P10 from US-RTX (US-RTX/CT-P10; n = 62) or EU-RTX (EU-RTX/CT-P10; n = 47) for an additional course.
Background: Studies in patients with rheumatoid arthritis and advanced follicular lymphoma have shown that CT-P10, a rituximab biosimilar, has equivalent or non-inferior efficacy and pharmacokinetics to rituximab. We aimed to assess the therapeutic equivalence of single-agent CT-P10 and rituximab in patients with newly diagnosed low-tumour burden follicular lymphoma.
Methods: In this ongoing, randomised, double-blind, parallel-group, active-controlled, phase 3 trial, adult patients (≥18 years) with stage II-IV low-tumour-burden follicular lymphoma were randomly assigned (1:1) using an interactive web or voice response system stratified by region, stage, and age to CT-P10 or US-sourced rituximab.
Background: Studies in patients with rheumatoid arthritis have shown that the rituximab biosimilar CT-P10 (Celltrion, Incheon, South Korea) has equivalent efficacy and pharmacokinetics to rituximab. In this phase 3 study, we aimed to assess the non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared with rituximab, when used in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with newly diagnosed advanced-stage follicular lymphoma.
Methods: In this ongoing, randomised, double-blind, parallel-group, active-controlled study, patients aged 18 years or older with Ann Arbor stage III-IV follicular lymphoma were assigned 1:1 to CVP plus intravenous infusions of 375 mg/m CT-P10 or rituximab on day 1 of eight 21-day cycles.
Objectives: To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).
Methods: This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg) was administered intravenously every 8 weeks from week 62 to week 102.
Growth factors play multiple and critical roles in wound repair processes. Platelet-derived growth factor (PDGF) is a potent growth factor that is particularly important in the early inflammatory phase of wound healing. In order to extend the half-life of PDGF, polymeric encapsulation is used.
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