Abstract Number: 559 • 2018 ACR/ARHP Annual Meeting
Radiographic Progression Based on Baseline Demographics and Disease Characteristics from Three TNF-Alpha Inhibitor Biosimilar Studies in Patients with Rheumatoid Arthritis
Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. Radiographic data were assessed using the modified Total Sharp Score (mTSS)…Abstract Number: 977 • 2018 ACR/ARHP Annual Meeting
Nurse Led Safe Switching from Original Reference Product Infliximab to Biosimalar in Patients with Juvenile Idiopathic Arthritis and Uveitis – a Single Centre Experience Including Baseline and Post Switch Infliximab Levels and Antibodies
Background/Purpose: Original Reference Product (ORP) Infliximab lost market exclusivity in europe in early 2015. The Scottish National Health service (SNHS), runs a national procurement system…Abstract Number: 1532 • 2018 ACR/ARHP Annual Meeting
Impact of Immunogenicity on Clinical Efficacy and Administration Related Reaction in TNF Inhibitors: A Pooled-Analysis from Three Biosimilar Studies in Patients with Rheumatoid Arthritis
Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. The phase III randomized, double-blind clinical studies comparing the efficacy and…Abstract Number: 1769 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India
Background/Purpose: Though rituximab(RTX) has become a standard of care for remission induction and maintenance in Granulomatosis with Polyangiitis(GPA), there is very limited data on the…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: 2461 • 2017 ACR/ARHP Annual Meeting
Rituximab Is Effective in the Treatment of Rheumatoid Arthritis Irrespective of Body Mass Index; Up to 48 Weeks Results from Phase 3 Study
Background/Purpose: High body mass index (BMI) is known to be associated with inadequate clinical response to anti-TNF agents in RA patients.1 However, there are limited…Abstract Number: 2484 • 2017 ACR/ARHP Annual Meeting
When Etanercept Switch Fails – Clinical Considerations
Background/Purpose: On January 14th 2016 EMA approved the biosimilar Etanercept (SB4, Benepali) for clinical use. A non-medical switch from originator Etanercept (ETA, Enbrel) to SB4…Abstract Number: 2492 • 2017 ACR/ARHP Annual Meeting
The Long-Term Safety and Durability of Response of Chs-0214, a Proposed Biosimilar to Etanercept: An Open-Label Safety Extension Study
Background/Purpose: CHS-0214 is a proposed biosimilar to etanercept for the treatment of rheumatoid arthritis and other auto-immune diseases. Two randomized, double-blind studies demonstrated equivalence of…Abstract Number: 2795 • 2017 ACR/ARHP Annual Meeting
Comparison of Switching from the Originator Rituximab to the Biosimilar Rituximab GP2013 or Re‑Treatment with the Originator Rituximab in Patients with Active Rheumatoid Arthritis: Safety and Immunogenicity Results from a Multicenter, Randomized, Double-Blind Study
Background/Purpose: GP2013, is a biosimilar to European Union (EU) approved reference rituximab (RTX), developed in a stepwise approach that adheres to stringent biosimilar development guidelines.…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…
ACR Meeting Abstracts