Abstract Number: 1936 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Background/Purpose: GP2017, a proposed adalimumab biosimilar, matched reference adalimumab (refADL) in preclinical and pharmacokinetics studies.1,2 The confirmatory efficacy and safety study in patients with plaque-type…Abstract Number: 2154 • 2018 ACR/ARHP Annual Meeting
Biosimilar Infliximab Treated-Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis in France: Characteristics and Clinical Outcomes
Background/Purpose: CT-P13 was the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Reflect trial has been set up to evaluate in real life…Abstract Number: 2367 • 2018 ACR/ARHP Annual Meeting
Acceptance Rate and Sociological Factors Involved in the Switch from Originator to Biosimilar Etanercept (SB4)
Background/Purpose: Biosimilars represent major potential savings while preserving treatment quality. However, few data are known on how to address the switch from originator to biosimilar…Abstract Number: 2384 • 2018 ACR/ARHP Annual Meeting
Biosimilar Use in Young Adults with Juvenile Idiopathic Arthritis in Germany
Background/Purpose: The first biosimilars have been approved for the treatment of juvenile idiopathic arthritis (JIA) in the last two years. To date, only a few…Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting
Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study
Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…Abstract Number: 2796 • 2017 ACR/ARHP Annual Meeting
A Randomized, Double Blind Trial over 52 Weeks to Demonstrate Bioequivalence of GP2013 and Reference Rituximab in Patients with Rheumatoid Arthritis
Background/Purpose: Rituximab (RTX) is a mAB indicated for the treatment of RA in patients with inadequate response to anti-TNF therapy. The current study compares the…Abstract Number: 455 • 2017 ACR/ARHP Annual Meeting
Analysis of Real-World Treatment Patterns in a Matched Sample of Rheumatology Patients with Continuous Infliximab Therapy or Switched to Biosimilar Infliximab
Background/Purpose: Biosimilar infliximab (CT-P13) was first approved in Europe in 2013.This study compared treatment (tx) patterns of Turkish pts with a diagnosis of rheumatoid arthritis(RA)…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.)…
ACR Meeting Abstracts