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: 2439 • 2017 ACR/ARHP Annual Meeting
Switching from RA Originator to Biosimilar in Routine Clinical Care: Early Data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis
Background/Purpose: Biosimilars, biopharmaceuticals assessed by regulatory agencies to have efficacy and safety similar to their reference products, were introduced to the UK market in February…Abstract Number: 2441 • 2017 ACR/ARHP Annual Meeting
A Phase III, Multicenter, Double-Blind, Randomized, Parallel-Group Study to Evaluate the Similarities between LBEC0101 and Etanercept Reference Product in Terms of Efficacy and Safety in Patients with Active Rheumatoid Arthritis Inadequately Responding to Methotrexate
Background/Purpose: LBEC0101 has been developed as a biosimilar to the etanercept reference product (ETN-RP). This study was to evaluate the similarities between LBEC0101 and ETN-RP…Abstract Number: 2445 • 2017 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar, CT-P10, after a Single Switch from Innovator Rituximabs in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 72 Weeks
Background/Purpose: Similarity of pharmacokinetic, efficacy and safety between CT-P10 and reference rituximab (RTX) were shown in the phase 3 randomized controlled trial (NCT02149121) up to…Abstract Number: 2447 • 2017 ACR/ARHP Annual Meeting
Effectiveness and Tolerability of Benepali in Rheumatoid Arthritis Patients Switched from Enbrel
Background/Purpose: Benepali, the etanercept biosimilar, is licenced in the UK for rheumatoid arthritis (RA) and costs less than Enbrel. This study aimed to evaluate the…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: 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: 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…
ACR Meeting Abstracts