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: 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: 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: 1635 • 2016 ACR/ARHP Annual Meeting
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Efficacy and Safety of CT-P10, Rituximab Biosimilar Candidate, and Innovator Rituximab in Patients with Rheumatoid Arthritis: Result from Phase 3 Randomized Controlled Trial over 24…Abstract Number: 1709 • 2016 ACR/ARHP Annual Meeting
Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis
Background/Purpose: CHS-0214 is a proposed biosimilar of etanercept, a fusion protein inhibiting tumor necrosis factor. This Phase III multi-center study compared the efficacy and safety…Abstract Number: 2596 • 2016 ACR/ARHP Annual Meeting
Comparable Safety and Immunogenicity and Sustained Efficacy after Transition to SB2 (An Infliximab Biosimilar) Vs Ongoing Reference Infliximab (Remicade®) in Patients with Rheumatoid Arthritis: Results of Phase III Transition Study
Background/Purpose: SB2 is approved by the European Medicines Agency as a biosimilar of the reference infliximab (INF). The 30-week and 54-week results of Phase III…
ACR Meeting Abstracts