A5100731806- Rheumatoid Arthritis Research and Therapies
- Systemic Lupus Erythematosus Research
- Biosimilars and Bioanalytical Methods
- Spondyloarthritis Studies and Treatments
- Autoimmune and Inflammatory Disorders Research
- Bone and Joint Diseases
- Monoclonal and Polyclonal Antibodies Research
- Lymphoma Diagnosis and Treatment
- Chronic Lymphocytic Leukemia Research
- Vasculitis and related conditions
- Inflammatory mediators and NSAID effects
- Pharmaceutical studies and practices
- Systemic Sclerosis and Related Diseases
- Gout, Hyperuricemia, Uric Acid
- Bone health and treatments
- Inflammasome and immune disorders
- Psoriasis: Treatment and Pathogenesis
- Microscopic Colitis
- Bone Metabolism and Diseases
- Ocular Diseases and Behçet’s Syndrome
- Hepatitis C virus research
- Osteomyelitis and Bone Disorders Research
- Inflammatory Myopathies and Dermatomyositis
- T-cell and B-cell Immunology
- Case Reports on Hematomas
Inha University
2014-2023
Samsung Medical Center
2023
Sungkyunkwan University
2023
Gachon University Gil Medical Center
2022
Texas Plastic Surgery
2022
Chonnam National University Hospital
2022
Inha University Hospital
2012-2021
Korea University
2018
Center for Rheumatology
2016
United Arab Emirates University
2011
<h3>Objectives</h3> To compare the efficacy and safety of innovator infliximab (INX) CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. <h3>Methods</h3> Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients disease despite MTX (12.5–25 mg/week) were randomised receive 3 mg/kg CT-P13 (n=302) or (n=304) folic acid. The primary endpoint was American College Rheumatology 20% (ACR20)...
<h3>Objectives</h3> To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). <h3>Methods</h3> Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised receive 5 mg/kg CT-P13 (n=125) or INX (n=125). Primary endpoints area under concentration-time curve (AUC) at steady state observed maximum serum concentration (C<sub>max,ss</sub>)...
Abstract Objective To assess the safety and efficacy of golimumab in methotrexate (MTX)–naive patients with active rheumatoid arthritis (RA). Methods MTX‐naive RA (n = 637) were randomized to receive placebo plus MTX (group 1), 100 mg 2), 50 3), or 4). Subcutaneous injections administered every 4 weeks. The dosage MTX/placebo capsules started at 10 mg/week escalated 20 mg/week. primary end point, proportion meeting American College Rheumatology 50% improvement criteria (achieving an ACR50...
Objectives To assess the efficacy and safety of switching from infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing in patients with rheumatoid arthritis (RA) for an additional six infusions. Methods This open-label extension study recruited RA who had completed 54-week, randomised, parallel-group comparing RP (PLANETRA; NCT01217086 ). (3 mg/kg) was administered intravenously every 8 weeks 62 102. All received concomitant methotrexate....
Objectives To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining treatment in patients with ankylosing spondylitis (AS). Methods This open-label extension study recruited AS who completed a 54-week, randomised controlled comparing CT-P13 RP (PLANETAS). (5 mg/kg) was administered intravenously every 8 weeks week 62 102. Efficacy end points included proportion achieving Assessment SpondyloArthritis international Society...
Objective. To evaluate efficacy and safety of CE-224,535, a selective P2X 7 receptor antagonist, versus placebo, in patients with active rheumatoid arthritis (RA) inadequate response to methotrexate (MTX). Methods. In our phase IIA study ( ClinicalTrials.gov no. NCT00628095 ; A6341009), aged ≥ 18 years RA were randomized receive either CE-224,535 (500 mg bid) or placebo for 12 weeks; all continued stable background dose 7.5 MTX. Results. The American College Rheumatology 20% (ACR20) rate...
CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®). The aim this study was to compare 54-week efficacy, immunogenicity, safety, pharmacokinetics (PK) and pharmacodynamics (PD) RP in patients with active rheumatoid arthritis (RA). In multinational phase III double-blind study, RA an inadequate response methotrexate (MTX) were randomized (1:1) receive (3 mg/kg) or at weeks 0, 2, 6 then every 8 week 54 combination MTX (12.5–25 mg/week). Efficacy...
Objective To demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) inadequate responses or intolerances to antitumour necrosis factor agents. Methods In this randomised phase I trial, active RA were randomly assigned (2:1) receive 1000 mg RTX at weeks 0 2 (alongside continued methotrexate therapy). Primary endpoints area under the serum concentration–time curve from time zero last quantifiable concentration (AUC 0–last )...
Objectives: This phase II, dose-ranging, double-blind, placebo-controlled, randomized study (NCT01463059) evaluated efficacy and safety of olokizumab (OKZ), a humanized anti-interleukin 6 monoclonal antibody, in Asian patients with moderately-to-severely active rheumatoid arthritis (RA) who had previously failed anti-TNF therapy.
This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 innovator rituximab (RTX) patients with rheumatoid arthritis (RA). Adults active RA were treated CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced (EU-RTX; MabThera®) at weeks 0 2. The co-primary pharmacokinetic endpoints area under the serum concentration–time curve (AUC) from...
To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after single switch, during multinational, randomized, double-blind Phase 3 trial involving patients with RA.Patients received 48 weeks' treatment CT-P10 or United States- European Union-sourced reference (US-RTX EU-RTX, respectively). Patients entering extension period (weeks 48-72) remained on (CT-P10/CT-P10; n = 122) US-RTX (US-RTX/US-RTX; 64), switched to from (US-RTX/CT-P10; 62) EU-RTX (EU-RTX/CT-P10; 47) for an...
The aim of this study was to determine whether skin temperature measurement by digital thermography on hands and feet is useful for diagnosis Raynaud's phenomenon (RP). Fifty-seven patients with RP (primary RP, n = 33; secondary 24) 146 healthy volunteers were recruited. After acclimation room 30 min, thermal imaging palmar aspect dorsal taken. Temperature differences between palm (center) the coolest finger foot dorsum first toe significantly differed controls. area under curve analysis...
Objective: To compare the pharmacokinetics (PK), safety and tolerability of biosimilar infliximab (CT-P13 [Remsima®, Inflectra®]) with two formulations reference medicinal product (RMP) (Remicade®) from either Europe (EU-RMP) or USA (US-RMP). Methods: This was a double-blind, three-arm, parallel-group study (EudraCT number: 2013–003173-10). Healthy subjects received single doses (5 mg/kg) CT-P13 (n = 71), EU-RMP 71) US-RMP 71). The primary objective to PK profiles for three formulations....
To evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.gov NCT01270997).Patients active RA received 25 mg or ETN subcutaneously twice-weekly MTX 48 weeks a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was proportion patients achieving American College Rheumatology 20% response (ACR20) at week 24 per-protocol study...
Women with Systemic Lupus ErythematosusWe performed a multicenter cross-sectional study of 134 sexually active systemic lupus erythematosus (SLE) patients to investigate the prevalence and risk factors for high human papilloma virus (HPV) infection cervical cytological abnormalities among Korean women SLE.In this study, HPV testing routine cytologic examination was performed.HPV typed using hybrid method or polymerase chain reaction.Data on 4,595 healthy were used comparison.SLE had greater...
Objective To assess 2‐year golimumab efficacy/safety in patients with active rheumatoid arthritis (RA) who had never taken methotrexate (MTX). Methods RA MTX (n = 637) were randomized (1:1:1:1) to placebo + (group 1), 100 mg 2), 50 3), or 4) every 4 weeks. Nonresponders based on week 28 swollen/tender joint counts changed treatment as follows: group 1 added mg, 2 MTX, 3 increased and no change. Most (85%) initiated at subsequently 52. After the last patient completed 52 blinding was broken,...
Diagnosis of adult-onset Still's disease (AOSD) is difficult because a lack pathognomonic findings and markers. The aim this study was to investigate the efficacy interleukin (IL)-18 free IL-18 in diagnosis follow-up patients with AOSD.Levels inflammatory cytokines, IL-18, binding protein (IL-18BP), were compared 80 AOSD 90 controls. divided into active inactive groups according activity, subdivided remission subgroup low activity subgroup. We erythrocyte sedimentation rate (ESR), C-reactive...
To evaluate the safety and efficacy of golimumab through 5 years in adults with active rheumatoid arthritis (RA) who had not previously received methotrexate (MTX).In GO-BEFORE study, 637 MTX-naive adult patients RA were randomized (1:1:1:1) to placebo + MTX (group 1), 100 mg 2), 50 3), or 4). Inadequate responders groups 1, 2, 3 entered early escape at week 28 MTX, respectively; remaining group 1 could cross over 52. Assessments included American College Rheumatology 20%/50%/70% improvement...
We propose a minimax formulation for removing backdoors from given poisoned model based on small set of clean data. This encompasses much prior work backdoor removal. the Implicit Bacdoor Adversarial Unlearning (I-BAU) algorithm to solve minimax. Unlike previous work, which breaks down into separate inner and outer problems, our utilizes implicit hypergradient account interdependence between optimization. theoretically analyze its convergence generalizability robustness gained by solving...
The objective of this study was to investigate clinical and radiographic features gender differences in Korean patients with adult-onset ankylosing spondylitis. Multicenter cross-sectional studies were conducted the rheumatology clinics 13 tertiary referral hospitals. All had a confirmed diagnosis spondylitis according modified New York criteria. Clinical, laboratory, evaluated disease activities assessed using Bath activity index. Five hundred five recruited. male female ratio 6.1:1....