Abstract Number: 2406 • 2019 ACR/ARP Annual Meeting
Hepatobiliary Events in >5000 Patients with Inflammatory Arthritis Treated with Biosimilar or Originator Etanercept in Routine Care, Results from the Danish Nationwide DANBIO Registry
Background/Purpose: Marketing of biosimilar biological drugs may significantly reduce drug costs if comparable safety and efficacy of originator and the biosimilar can be documented. In…Abstract Number: 205 • 2019 ACR/ARP Annual Meeting
Does a Mandatory Non-medical Switch from Originator to Biosimilar Etanercept Lead to Increase in Healthcare Use and Costs? A Danish Register-based Study of 1620 Patients with Inflammatory Arthritis
Background/Purpose: Marketing of cheaper biosimilar biological agents has created financial incentives for switching from the corresponding originator drugs (=non-medical switch). The economic benefit might potentially…Abstract Number: 207 • 2019 ACR/ARP Annual Meeting
Effects of Successive Switches to Different Biosimilars Infliximab on Immunogenicity in Chronic Inflammatory Diseases in Daily Clinical Practice
Background/Purpose: To determine whether the successive switches from innovator infliximab to a first then a second biosimilar infliximab, or from a first to a second…Abstract Number: 251 • 2019 ACR/ARP Annual Meeting
Long-term Financial Impact of Switching from Reference to Biosimilar Etanercept When Considering Short-term Formulary Management Costs in the US
Background/Purpose: Biosimilars have enabled some US institutions and payers to achieve significant financial savings after implementing a formulary change from the reference biologic. However, within…Abstract Number: 310 • 2019 ACR/ARP Annual Meeting
Efficacy, Immunogenicity and Cost Analysis of a Systematic Switch from Originator Infliximab to Biossimilar CT-P13 of All Patients with Inflamatory Arthritis from a Single Center
Background/Purpose: Biotechnological drugs are a fundamental resource for the treatment (Tx) of rheumatic patients (Pts). Biosimilar drugs are intended to be as effective as the…Abstract Number: 514 • 2019 ACR/ARP Annual Meeting
A Pooled Analysis of 1-year Clinical Outcomes Among 6-month Responders and Non-responders from Three Randomized Controlled Studies of TNF Inhibitor Biosimilars in Patients with Rheumatoid Arthritis
Background/Purpose: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomized, double-blind studies were conducted to compare efficacy and safety between…Abstract Number: 519 • 2019 ACR/ARP Annual Meeting
Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components
Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…Abstract Number: 536 • 2019 ACR/ARP Annual Meeting
PERFUSE: A French Prospective/Retrospective Non-interventional Cohort Study of Infliximab-naïve and Transitioned Patients Receiving Infliximab Biosimilar SB2; An Interim Analysis
Background/Purpose: SB2 is approved in the EU as an infliximab (IFX) biosimilar, having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the reference. There…Abstract Number: 540 • 2019 ACR/ARP Annual Meeting
Comparing Real-world Retention Rates in a Matched Cohort of Rheumatoid Arthritis Patients Who Either Remained on the Etanercept Originator or Switched to a Biosimilar
Background/Purpose: In Germany, the first etanercept biosimilar was licensed in 2016. In contrast to other European countries there is no uniform recommendation for the prescription…Abstract Number: 541 • 2019 ACR/ARP Annual Meeting
Multicenter, Evaluator-blinded, Randomized, Non-inferiority Study, to Assess the Efficacy, Safety and Immunogenicity of Etanercept Biosimilar (EtaBS) vs. Reference Etanercept (EtaRef) in Combination with Methotrexate for the Treatment of Patients with Rheumatoid Arthritis
Background/Purpose: Enerceptan® (EtaBS) has been developed as a proposed biosimilar of etanercept. Phase I study demonstrated pharmacokinetic equivalence with EtaRef.Methods: A multicenter, non-inferiority, randomized, assessor -blinded,…Abstract Number: 542 • 2019 ACR/ARP Annual Meeting
‘BENEFIT’ Pan-European Observational Study to Evaluate the Real-world Effectiveness of SB4 Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis: A Switch Success Story
Background/Purpose: SB4, a biosimilar to the reference ETN, received EU marketing authorisation in January 2016, based on the totality of evidence from pre-clinical and clinical…Abstract Number: 549 • 2019 ACR/ARP Annual Meeting
US Rheumatologists’ Beliefs and Knowledge About Biosimilars – an Ongoing Survey
Background/Purpose: A systematic review of survey literature from 2014-2018 found that clinicians in the US and Europe are cautious about biosimilar use (JMCP; 2019;25:102). We…Abstract Number: 1115 • 2019 ACR/ARP Annual Meeting
Switching Patterns Among Patients with Chronic Inflammatory Diseases Switching to an Infliximab Biosimilar or Remaining on Originator Infliximab (REMICADE)
Background/Purpose: Chronic inflammatory diseases (CIDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), Crohn's disease (CD), and ulcerative colitis…Abstract Number: 1116 • 2019 ACR/ARP Annual Meeting
Non-medical Switching from Reference to Biosimilar Etanercept – No Evidence for Nocebo Effect – a Retrospective Analysis of Real-life Data
Background/Purpose: Real-world data about switching patients from originator product to a biosimilars are important to assess and to document the outcome of switches in clinical…Abstract Number: 1118 • 2019 ACR/ARP Annual Meeting
US Community Rheumatologists’ Knowledge and Perceptions of Biosimilar Expanded Indication Approval by Extrapolation
Background/Purpose: To expand treatment options, increase access to life-saving medications, and lower healthcare costs through competition, the US Congress created an abbreviated licensure pathway for…
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