Abstract Number: 2644 • 2016 ACR/ARHP Annual Meeting
Patient Survey Regarding Generic and Bio-Similar Drugs
Background/Purpose: In Japan the market share for generic drugs is 50%, lower than that in Western nations. This is partially due to Japan’s insurance system,…Abstract Number: 603 • 2016 ACR/ARHP Annual Meeting
Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4
Background/Purpose: SB4 is approved by the European Medicines Agency as a biosimilar of the reference etanercept (ETN). Long term safety and efficacy of SB4 up…Abstract Number: 604 • 2016 ACR/ARHP Annual Meeting
Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
Background/Purpose: SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 24-week results of the phase III study have been reported.1 Efficacy,…Abstract Number: 621 • 2016 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT- P13 (Biosimilar Reference Infliximab) in a Real-Life Setting in 151 Patients with Rheumatoid Arthritis and Ankylosing Spondylitis: A Mid-Term Interim Analysis
Background/Purpose: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, the high…Abstract Number: 622 • 2016 ACR/ARHP Annual Meeting
Efficacy after Transition to SB5 from Reference Adalimumab (Humira®) Vs. Continuation of SB5 or Reference Adalimumab By Antibodies Developed after Transition from a SB5 Phase III Study
Background/Purpose : SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 52-week efficacy and safety results were reported previously. 1 Here…Abstract Number: 627 • 2016 ACR/ARHP Annual Meeting
Clinical and Immunogenicity Outcomes after Switching Treatment from Innovator Infliximab to Biosimilar Infliximab in Rheumatic Diseases in Daily Clinical Practice
Background/Purpose: Biosimilar infliximab is registered in Europe for the same therapeutic indications as innovator infliximab. In 2015, four rheumatology departments in the Netherlands decided to…Abstract Number: 638 • 2016 ACR/ARHP Annual Meeting
A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects
Background/Purpose: The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…Abstract Number: 721 • 2016 ACR/ARHP Annual Meeting
Safety and Efficacy of Switching from Originator to CT-P13 Infliximab Biosimilar in Patients Affected By Spondyloarthritis. a 6-Month Observational Study
Background/Purpose: Biosimilar infliximab (INX) was recently approved by the European Medicine Agency based on comparable pharmacokinetics, safety and efficacy profile to innovator INX for the…Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…Abstract Number: 438 • 2015 ACR/ARHP Annual Meeting
Comparison of the Stanford and Indian Health Assessment Questionnaires for Disability Outcomes in a Phase 3, Randomized, Double-Blind, Active Comparator Study of Infliximab and Biosimilar Infliximab BOW15 in Rheumatoid Arthritis
Background/Purpose: The Stanford Health Assessment Questionnaire (HAQ) includes several questions that are more relevant to rheumatoid arthritis (RA) patients in Western countries than to those…Abstract Number: 1221 • 2015 ACR/ARHP Annual Meeting
Characteristics and Outcomes of RA Patients Who Start Biosimilar Infliximab in South Korea
Background/Purpose: Recently biosimilar infliximab was approved in South Korea and it has been commonly used for rheumatoid arthritis (RA) patients who are resistant to conventional…Abstract Number: 1273 • 2015 ACR/ARHP Annual Meeting
Uptake of the First Biosimilar Infliximab Since Its Approval in South Korea
Background/Purpose: Development of tumor necrosis factor (TNF) inhibitors has been a major advance in treatment of systemic inflammatory diseases, such as rheumatoid arthritis. While TNF…Abstract Number: 1675 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Switched CT-P10 from Innovator Rituximab Compared to Those of Maintained CT-P10 in Patients with Rheumatoid Arthritis up to 56 Weeks
Background/Purpose: Pharmacokinetic (PK) equivalence and similarity of clinical efficacy, safety and immunogenicity up to week 24 were demonstrated between CT-P10, a biosimilar candidate for innovator…Abstract Number: 2057 • 2015 ACR/ARHP Annual Meeting
Antibodies to Infliximab in Remicade-Treated Rheumatic Patients Show Identical Reactivity Towards Biosimilars
Background/Purpose: Infliximab (IFX) is the most immunogenic of anti-TNFα drugs available to treat patients with rheumatic diseases. The recent approval of the first infliximab biosimilars in…
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