Abstract Number: 2797 • 2017 ACR/ARHP Annual Meeting
Etanercept Biosimilar GP2015 Has Equivalent Efficacy and Safety to Etanercept Originator in Patients with Moderate to Severe Rheumatoid Arthritis: The Phase 3 Equira Study
Background/Purpose: The biosimilarity of GP2015 and etanercept originator product (ETN) has been previously demonstrated in patients with chronic plaque-type psoriasis.1 The randomized, double-blind, phase 3…Abstract Number: 1037 • 2017 ACR/ARHP Annual Meeting
Biosimilar Knowledge Among US Rheumatologists – a Survey
Background/Purpose: Four biosimilar tumor necrosis factor α (TNFα) inhibitors have been approved by the FDA in the United States as of April 2017. This survey…Abstract Number: 2798 • 2017 ACR/ARHP Annual Meeting
A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment for Patients with Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Therapy
Background/Purpose: This double-blind, randomized study evaluated efficacy, safety and immunogenicity of PF‑06438179/GP1111, a potential infliximab biosimilar, vs infliximab sourced from the EU (infliximab-EU) in patients…Abstract Number: 1041 • 2017 ACR/ARHP Annual Meeting
Real-World Utilization of Biosimilars for Management of Rheumatoid Arthritis (RA) in the US
Background/Purpose: A biosimilar product is a biological product highly similar to another FDA-approved biological product, reference product, and has no clinically meaningful differences in safety…Abstract Number: 2799 • 2017 ACR/ARHP Annual Meeting
Efficacy, Safety and Immunogenicity in Randomized, Double-Blind (DB) and Open-Label Extension (OLE) Studies Comparing FKB327, an Adalimumab Biosimilar, with the Adalimumab Reference Product (Humira®; RP) in Patients (pts) with Active Rheumatoid Arthritis (RA)
Background/Purpose: FKB327 is a proposed biosimilar of the adalimumab RP. A randomized, DB, Phase 3 study (NCT02260791) compared the efficacy, safety, pharmacokinetics (PK) and immunogenicity…Abstract Number: 1549 • 2017 ACR/ARHP Annual Meeting
A Non-Medical Switch from Originator Infliximab to Biosimilar CT-P13 in 36 Patients with Ankylosing Spondylitis: 6 – Months Clinical Outcomes from the Czech Biologic Registry Attra
Background/Purpose: A non-medical switch from originator (INX, Remicade) to biosimilar infliximab (CT-P13, Remsima) was conducted in 36 patients with ankylosing spondylitis (AS) in one clinical…Abstract Number: 2800 • 2017 ACR/ARHP Annual Meeting
Long-Term Safety and Efficacy of Biosimilar Infliximab (CT-P13) after Switching from Originator Infliximab: Results from the 26-Week Open Label Extension of a Randomized Norwegian Trial
Background/Purpose: TNF-inhibitors (TNFi) have improved treatment of rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA) , Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque…Abstract Number: 1550 • 2017 ACR/ARHP Annual Meeting
One-Year Clinical Outcomes in 1623 Patients with Inflammatory Arthritis Who Switched from Originator to Biosimilar Etanercept – an Observational Study from the Danish Danbio Registry
Background/Purpose: According to Danish national guidelines issued in April 2016, a non-medical switch from originator (ETA, Enbrel) to biosimilar Etanercept (SB4, Benepali) (50 mg s.c.)…Abstract Number: 2879 • 2017 ACR/ARHP Annual Meeting
Switching from Adalimumab to Chs-1420: A Randomized, Double-Blind Global Clinical Trial in Patients with Psoriasis and Psoriatic Arthritis
Background/Purpose: CHS-1420 is a proposed biosimilar to adalimumab. A phase 3, randomized, double-blind, multicenter study evaluated the equivalence of CHS-1420 to adalimumab in patients with…Abstract Number: 2260 • 2017 ACR/ARHP Annual Meeting
Communication Strategies Are Highly Important to Avoid Nocebo Effect When Performing Non-Medical Switch from Originator Product to Biosimilar Product: Danish Results from Applying the Parker Model a Qualitative 3-Step Research Model
Background/Purpose: Introducing a non-medical switch from originator to a biosimilar product in the management of chronic arthritis, i.e. switching patients in remission or low disease…Abstract Number: 2438 • 2017 ACR/ARHP Annual Meeting
Open Label Transitioning from Originator Etanercept to Biosimilar SB4 Compared to Continuing Treatment with Originator Etanercept in a Historical Cohort in Rheumatic Diseases in Daily Practice
Background/Purpose: Blinded transitioning from originator infliximab (INX) to biosimilar CT-P13 was not inferior to continuing INX treatment.1 Open label mandatory transitioning resulted in a slightly…Abstract Number: 19L • 2016 ACR/ARHP Annual Meeting
Biosimilar Infliximab (CT-P13) Is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway
Background/Purpose: TNF-inhibitors (TNFi) have improved treatment of spondyloarthritis (SpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), Crohn’s disease (CD), ulcerative colitis (UC), and chronic plaque…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…
ACR Meeting Abstracts